Body Language Issue 52

july/aug

52 The UK Journal of Medical Aesthetics and Anti-Ageing www.bodylanguage.net

MARKING PATIENTS Surgeon’s tips for pre-op mapping

PSYCHOLOGY

How toxin treats depression

BURN SCARS

Success with fractional CO2

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contents

body language number 52 16

PEER PRESS REVIEW David Williams surveys academic and association journals to report on advances in research

16 SURGERY CHARTING SUCCESS Markings in aesthetic procedures are the plastic surgeon’s map to arriving at a good or excellent result, writes Mr Michael Cadier

Assistant Editor Helen Twinam 01273 622 944 helent@face-ltd.com

19

Classified Sales Simon Haroutunian 020 7514 5982 simon@face-ltd.com

19 SURGERY GYNAECOMASTIA Gynaecomastia, or “man boobs”, is a two-component problem, writes Mr Alex Karidis. He describes a combination treatment, using power-assisted liposuction with a modified pull-through technique

23 PSYCHOLOGY

Publisher Head of Sales Raffi Eghiayan 020 7514 5101 raffi@face-ltd.com Contributors Mr Michael Cadier Mr Alex Karidis Dr Raj Persaud Dr Peter Bruggen Mr Anthony Erian Dr Tapan Patel Eddie Hooker Dr Masud Haq Professor Syed Haq Dr Stephen Bassett Andy Pickett Dr Dennis Hurwitz Dr Luiz Toledo Dr Christine Coffey Geoff Bond Dr David Goldberg Mr Lucian Ion Dr Matteo Tretti Clementoni Professor Syed Haq Dr Soren Demin Mr Taimur Shoaib

ANALYSES Reports and comments

14 RESEARCH

Editor David Williams 01273 622 944 david@face-ltd.com

Designer Helen Unsworth 020 7514 5981 helen@face-ltd.com

9 OBSERVATIONS

TURN THAT FROWN UPSIDE DOWN Dr Raj Persaud and Dr Peter Bruggen report on research that injected botulinum toxin for alleviating symptoms of depression

24 CLINICAL

27

LIP READING Filling out the lips requires good technique and an appreciation of their geometry. Mr Anthony Erian discusses how he produces beautiful aesthetic lips

27 LASER BURNS SCAR REVISION Traditional ablative laser treatments for scarring are well documented but have a history of side effects and extended downtime. Dr Tapan Patel discusses the use of fractional CO2 laser for treating burns scars

30 INSURANCE HOW MUCH FOR COVER? Insurance premiums are always a source of much discussion.

Eddie Hooker discusses how insurance companies calculate the premiums they charge for policies

41 ISSN 1475-665X The Body Language® journal is published six times a year by FACE Ltd. All editorial content, unless otherwise stated or agreed to, is © FACE Ltd 2012 and cannot be used in any form without prior permission. The single issue price of Body Language is £10 in the UK; £15 rest of the world. A six-issue subscription costs £60 in the UK, £85 in the rest of the world. All single issues and subscriptions outside the UK are dispatched by air mail. Discounts are available for multiple copies.

Printed by Buxton Press Ltd. Enquiries, orders and all other mail should be addressed to Body Language, 2D Wimpole Street, London, England, W1G 0EB. To contact Body Language by telephone, please call us on +44(0)20 7514 5982.

Editorial e-mail: editorial@face-ltd.com Advertising: advertising@face-ltd.com Body Language can be ordered online at www.bodylanguage.net body language www.bodylanguage.net

32 REGULATION CALLED TO ACCOUNT Misinformation abounds in medicine’s regulatory circles, particularly pertaining to the safety of approved devices.

Helen Twinam delves into European and American medical regulations to report on how they promote safety

41 SPECIAL REPORT THYROID DISORDERS Controversy surrounds the best methods for diagnosing thyroid disorders and there are numerous opinions on how best to manage the condition. Many patients on thyroid hormone replacement are either under- or over-replaced. Dr Masud Haq and Professor Syed Haq unravel some of these issues

3

body language

editorial panel Dr Jean Carruthers MD, FRCSC, FRC is clinical professor in the department of ophthalmology and visual sciences at the University of British Columbia in Vancouver, where she specialises in facial cosmetic surgery. With her husband, Dr Alastair Carruthers, she has received the Kligman award from ASCDAS .

number 52

47

62

Rohit Kotnis MRCS (Lon), Dip SEM (Ed) practises from clinics in Oxfordshire and Buckinghamshire and is a trainer in advanced botulinum toxin and dermal filler applications. He has published extensively in musculoskeletal and trauma research journals and specialises in sports and soft tissue injuries.

Professor Syed Haq trained at Harvard Medical School, Massachusetts General Hospital and Tufts University, New England Medical Center. Professor Haq is Director of The London Preventative Medicine Centre, Harley Street.

Syed is an honorary consultant at the Chelsea and Westminster Hospital NHS Foundation Trust.

Professor Andy Pickett has worked on botulinum toxins for over 23 years. Andy has lectured around the world on the products, translating the science into practical understanding for injectors. In 2011 Andy founded Toxin Science Ltd and is head of development at Q-Med.

45 PRODUCTS Fiona Collins and Marie Duckett are registered nurses and members of the Royal College of Nursing forum for nurses in aesthetic medicine. Their clinic, Fiona and Marie Aesthetics Ltd, is based in Harley Street.

Anthony Erian FRCS (Erg) FRCS (Ed) is an aesthetic plastic surgeon with more than 30 years’ experience.

He is a member of the American Academy of Aesthetic and Restorative Surgery and chairman of the European Academy of Aesthetic Surgery. Mr Erian practices in Cambridge and Harley St. Dr Stephen Bassett is medical director of the Aesthetic Training Academy and ShapeCYMRU Cosmetics. He is a Syneron luminary and member of the Merz academy, focusing on RF facial procedures. He is a barrister, fellow of the Society of Advanced Legal Studies and a legal consultant.

Elizabeth Raymond Brown, Phd, CRadP, MSRP authored the internationally recognised BTEC qualifications in medical and aesthetic laser/IPL therapies and national occupational standards in light-based therapies.

She is now director of education at LCS Academy Ltd in Milton Keynes.

Dr Séan Cummings MBBS T(GP), DRCOG, DFFP, MRCGP, LLM is a cosmetic doctor practising in Harley Street. Dr Cummings has more than 20 years’ experience as a practitioner and has a masters degree in medical law.

Dr Cummings works as an expert witness and has sat on GP disciplinary hearings Renato Calabria MD is part of the voluntary faculty of the Department of Plastic Surgery at the University of Southern California, Los Angeles. He is a member of the American Society of Plastic Surgery, and the International Society of Plastic Surgery. Dr Calabria practises in Beverly Hills, Milan and Rome.

Dr Bessam Farjo MB ChB BAO LRCP&SI practises hair restoration at his clinics in Manchester and London.

Dr Farjo is a fellow International College of Surgeons, founder member British Association of Hair Restoration Surgeons and president of the International Society of Hair Restoration Surgery.

Dr Masud Haq BSc, MRCP, MD is a consultant in diabetes and endocrinology who practises at Tunbridge Wells and 10 Harley Street. Dr Haq is a graduate of Guy’s and St Thomas’s Hospital, and he trained at Johns Hopkins in the US and in Melbourne. He has written for numerous publications and has a particular interest in the thyroid and menopause.

4

ON THE MARKET Latest arrivals that are stirring discussion in aesthetics

47 PEER TO PEER LASERS, DIETS AND LONGEVITY Our expert panel cover a range of topics from laser recommendations to weight loss, oxidative stress and our 60,000 year old ancestors

52 ESSAY CRAFTSMANSHIP AND CREDIBILITY Aesthetic medicine is distinguished by the direct communication between patient and practitioner and the pleasure both experience in receiving and delivering a good result.

Dr Stephen Bassett elaborates on why medical practitioners should revel in this relative simplicity

55 RESEARCH DISPELLING A FEW MYTHS Botulinum toxins’ versatility continues to march on. Andy Pickett discusses some of the advances toxins have made in academic and clinical study while addressing popular misconceptions

58 SURGERY L BRACHIOPLASTY WITH LIPO Good candidates for L brachioplasty with liposuction are healthy and concerned about excess skin and fat of the entire upper arms and are prepared to accept a long scar running along the inner arm, writes Dr Dennis Hurwitz

62 SURGERY BRAZILIAN BUTTOCKS The pioneer of the Brazilian buttock technique revisits his procedure 25 years later. Dr Luiz Toledo says it still stirs debate at congresses despite years of success

66 COMMENT CONCLUSION Letter from the Editor, cartoon

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Azzalure® Abbreviated Prescribing Information Presentation: Botulinum toxin type A (Clostridium botulinum toxin A haemagglutinin complex) 10 Speywood units/0.05ml of reconstituted solution (powder for solution for injection).

Indications: Temporary improvement in appearance of moderate to severe glabellar lines seen at frown, in adult patients under 65 years, when severity of these lines has an important psychological impact on the patient. Dosage & Administration: Botulinum toxin units are different depending on the medicinal products. Speywood units are specific to this preparation and are not interchangeable with other botulinum toxins. Reconstitute prior to injection. Intramuscular injections should be performed at right angles to the skin using a sterile 29-30 gauge needle.

Recommended dose is 50 Speywood units (0.25 ml of reconstituted solution) divided equally into 5 injection sites,: 2 injections into each corrugator muscle and one into the procerus muscle near the nasofrontal angle. (See summary of product characteristics for full technique). Treatment interval should not be more frequent than every three months. Not recommended for use in individuals under 18 years of age. Contraindications: In individuals with hypersensitivity to botulinum toxin A or to any of the excipients. In the presence of infection at the proposed injection sites, myasthenia gravis, Eaton Lambert Syndrome or Amyotrophic lateral sclerosis. Special warnings and precautions for use: Use with caution in patients with a risk of, or clinical evidence of, marked defective neuro-muscular transmission, in the presence of inflammation at the proposed injection site(s) or when the targeted muscle shows excessive weakness or atrophy. Patients treated with therapeutic doses may experience exaggerated muscle weakness. Not recommended in patients with history of dysphagia, aspiration or with prolonged bleeding time. Seek immediate medical care if swallowing, speech or respiratory difficulties arise. Facial asymmetry, ptosis, excessive dermatochalasis, scarring and any alterations to facial anatomy, as a result of previous surgical interventions should be taken into consideration prior to injection.

Injections at more frequent intervals/higher doses can increase the risk of antibody formation. Avoid administering different botulinum neurotoxins during the course of treatment with Azzalure. To be used for one single patient treatment only during a single session. Interactions: Concomitant treatment with aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) may potentiate effect of botulinum toxin. Pregnancy & Lactation: Not to be used during pregnancy or lactation. Side Effects: Most frequently occurring related reactions are headache and injection site reactions.

Generally treatment/injection technique related reactions occur within first week following injection and are transient and of mild to moderate severity and reversible. Very Common (≥ 1/10): Headache, Injection site reactions (e.g. erythema, oedema, irritation, rash, pruritus, paraesthesia, pain, discomfort, stinging and bruising). Common (≥ 1/100 to < 1/10): Facial paresis (predominantly describes brow paresis), Asthenopia, Ptosis, Eyelid oedema, Lacrimation increase, Dry eye, Muscle twitching (twitching of muscles around the eyes). Uncommon (≥ 1/1,000 to <1/100): Dizziness, Visual disturbances, Vision blurred, Diplopia, Pruritus, Rash, Hypersensitivity. Rare (≥ 1/10,000 to < 1/1,000): Eye movement disorder, Urticaria. Adverse effects resulting from distribution of the effects of the toxin to sites remote from the site of injection have been very rarely reported with botulinum toxin (excessive muscle weakness, dysphagia, aspiration pneumonia with fatal outcome in some cases).

Packaging Quantities & Cost: UK 1 Vial Pack (1 x 125u) £64.00 (RRP), 2 Vial Pack (2 x 125u) £128.00 (RRP) IRE 2 Vial Pack (2 x 125u) €187.05 (RRP). Marketing Authorisation Number: PL 06958/0031 (UK), PA 1609/001/001(IRE). Legal Category: POM. Full Prescribing Information is Available From: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts.

WD17 1DS, UK. Tel: +44 (0) 1923 208950 Fax: +44 (0) 1923 208998. Date of Revision: January 2011.

Adverse events should be reported.

Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Galderma (UK) Ltd.

Azzalure® is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.

The passage of time

A secret to reveal beauty

Azzalure® is a Botulinum Toxin Type A for aesthetic use.

• Fast onset of action (median time to onset 2-3 days)1 • Long duration of action (up to 5 months)1 • High level of patient satisfaction (93% after 6 months, following one treatment session)2

References 1. Azzalure® Summary of Product Characteristics.

2. Ascher B et al. J Am Acad Dermatol 2004; 51: 223-33.

Azzalure® is a registered trademark of Galderma.

Date of preparation: February 2012 AZZ/005/0212

an aesthetic choice

observations

PIP implants ‘substandard, not toxic’ Expert group’s review says implants pose no long-term risk, but critics deem report ‘premature’ Since the dawn of the Poly Implant Prosthese (PIP) scandal, there has been much hearsay and speculation. Inflated rupture rates and fears of carginogenic properties have fanned the anxious flames of women with the implants. A government report by professor Sir Bruce Keogh’s expert group has attempted to quell public concern, revealing the implants pose minimal longterm risk to health. But critics say the report is premature and that a more in-depth examination is needed.

Health secretary Andrew Lansley ordered the review in December 2011, following conflicting and inconsistent rupture data submitted by private clinics. The group’s final report, published on 18 June, studied information on 240,000 implants of different makes, given to 130,000 women, as well as findings from 5,600 removal operations.

They state that worldwide testing of PIP gel material has not revealed anything that could cause a long-term threat to human health, and it is not toxic or carcinogenic.

Studies have found the implant material contains a higher concentration of siloxanes, which are chemically similar to silicone but have a lower molecular weight. These do not present a health risk, the

group says, and are found in a number of consumer hair- and skin-care products.

But while the PIP material has been deemed safe, the report concedes the implants have a much higher rupture rate and are therefore a “substandard product”. The rate of rupture rises from 6–12% after five years, to 15–30% after 10 years—around twice that of other implant brands.

Scottish campaign group PIP Implants Scotland says the report is predictable and does little to allay fears. Spokesperson Trisha Devine says the published results were disappointing. “We thought the rupture rate would be higher than officials expected and we were hoping for a fresh insight into the scandal.

“Instead we get a rehashed version of the previous government report,” she says, “which states that the implants are defective and says they’re likely to rupture, spilling industrial silicone into our bodies. How are those of us with PIP implants supposed to feel about that?

Does the government expect us to be relieved?”

On rupturing, the implants have been found to cause reactions around the implant area in a small number of women, resulting in tenderness and swollen lymph glands. But this causes no significant health

concern, says the report. The group states that the advice so far given to women with the implants remains unchanged.

Patients who decide to keep their implants should be followed up on an annual basis and be made aware of all signs associated with an implant rupture, according to guidelines issued independently by surgical associations participating in the group (www.rcseng.ac.uk/publications/docs/pip-statement).

Earlier this year, advice issued by government officials played down rupture fears, stating that patients should not routinely have the implants removed. Andrew Lansley said in January that it was not advisable because the risk would outweigh the benefit of removing the implants”.

But the British Association of Aesthetic Plastic Surgeons, represented on the expert group by its president, Mr Fazel Fatah, stresses that all women should be offered removal by their provider; not just those with rupture or associated symptoms.

“Available data shows that, should intact implants be left in the body, there is still a 15–30% chance that patients may need removal or replacement surgery at some stage,” says Mr Fatah. “That ‘silent’ ruptures do not manifest in outward symptoms will in all likelihood not reassure many of

those affected, so we welcome the decision that any and all women should be given the option to discuss their individual needs and should be fully supported by their provider, whatever their choice, removal or monitoring,” Mr Fatah says.

Professor Laurence Kirwan, a consultant plastic and reconstructive surgeon who has offices in the UK and US, agrees that all those with the implants should be offered removal. But he says the report is premature and lacks reassurance.

“The effects of any substance can take many years to evaluate—besides which we know that these implants will self-destruct. So are we seriously suggesting that the GP and the tertiary specialist will be able to change the likely outcome with a verbal reassurance?”

“I would not take much comfort in a suggestion to wait and see if the breast changes in shape or for some associated symptoms before seeking removal. Once again it is a masterful brew of scientific reasoning without the addition of a pinch of common-sense or humanity,” says Professor Kirwan.

A separate review by Sir Bruce Keogh is under way (see “PIP and CE marking,” p38), investigating industry regulation for cosmetic interventions, and assessing the need for a breast implant registry.

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observations

Convenience drives aesthetic market Home-use devices a growing segment Purse strings have tightened and convenience embraced as more people opt for homebased aesthetic treatments, according to a report from healthcare intelligence provider GlobalData.

The annual report, Aesthetic Lasers and Energy Devices— Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2018, analyses the global aesthetic devices market, which by 2018 is anticipated to double in value to $3bn.

Home-use devices are the fastest growing segment and is projected to grow by 13% within six years, says GlobalData.

Applications include hair removal, facial rejuvenation and wrinkle and acne treatments.

The market is kept buoyant because of the need for repeated usage to achieve desired results.

In its 2011 report, Glo-

balData stated that emerging economies had huge potential for body contouring procedures because of rising income and increased affordability. This year’s report focuses on a sharp increase in obesity rates in economies such as China and India.

Around 38% of Chinese and 20% of Indians are overweight, says the report. Increased obesity, both in Western and emerging economies, will lead to more bariatric and body contouring procedures. Laser-assisted liposuction may drive the market for minimally invasive body contouring devices.

Fractional non-ablative lasers will dominate the skin resurfacing market, owing to lower costs, downtime and convenience. “These treatments all share a focus on accessibility within a modern busy lifestyle,” says GlobalData.

Dermal bra technique results get even better Modifications improve efficacy, say authors A surgical technique reported in 2003 for reduction mammaplasty or mastopexy has shown even better results following long-term follow-ups and modifications.

A study, published in the June issue of Plastic and Reconstructive Surgery, shows successful long-term outcomes for the dermal bra technique for mammaplasty and ptosis. In the 2003 study, of the 32 patients treated, 28 had satisfactory results, including good mammary appearance, an ‘invisible’ scar, stable breast projection and lasting results. The overall complication rate was 12.5%.

Long-term study investigators looked at 347 patients across China who underwent the technique between 2003– 2011, 213 of whom were fol-

lowed for up to two years after the procedure. About 8% of patients suffered short-term complications, such as haematoma, delayed wound healing, fat necrosis, deep folds and numbness of the nipple-areola complex.

Long-term complications, including widened scar and enlarged areola, irregular areola, secondary ptosis, sunken nipple-areola complex, numbness, cysts and chronic infection, occurred in 6.6% of patients.

Three modifications were made to improve the technique: W- or V- shaped gland resection, medial rotation of the gland flap and modified purse-string suture. Complication rates and satisfaction rate of latter treatments were improved, according to the study.

body language www.bodylanguage.net

60

second brief

UNDER THE SKIN Nearly half of skin disease sufferers have been verbally abused by a member of the public, and 17% have contemplated suicide, according to a survey of 729 people, carried out by the British Skin Foundation.

Respondents were asked about their skin condition, such as eczema, acne or psoriasis, and its daily impact.

Dr Anthony Bewley, spokesperson for the British Skin Foundation, says the psychological impact of skin disease is often underestimated. “Many patients consider their skin conditions to be more psychologically damaging than diabetes or heart disease.”

68%

say the number one issue caused by their skin disease was a fall in self-confidence

20%

of people have been bullied regularly about their appearance

46%

of people with a skin disease have been verbally abused by a member of the public

12%

have suffered physical abuse by a member of the public at least once

56%

say their condition is a major obstacle in making new friends

20%

say their skin disease was the driving factor for the breakdown of a relationship

29%

class their skin condition as an active barrier in finding a partner

42% feel the biggest area affected is their work life 37%

of people have received unfair treatment at work or full-time education

17%

have been driven to contemplate suicide because of their condition, and 16% have self-harmed Source: The British Skin Foundation

11

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observations

training & events Facial defects self-repair JULY

SEPTEMBER

16th July SkinGeeks London Theory and Practical, London W: skingeeks.co.uk

1st September Dr Brian Franks Advanced Dermal Fillers (Volumising) Training Course Part III, London W: drbrianfranks.com

17th - 18th July Introduction to Dermal Fillers, Skincare & Chemical Peels Courses, Wigmore Medical, London W: wigmoremedical.com/events

1st September Microsclerotherapy and Facial Telangiectasia Course, Wigmore Medical, London W: wigmoremedical.com/events

18th July HealthXchange Obagi Training Workshop, London W: obagi.uk.com 19th July Cosmetic Courses Dermaroller, Chemical Peel & Microdermabrasion Training Course, National Training Centre, The Paddocks Clinic, Bucks W: cosmeticcourses.co.uk

3rd September LCS Academy Laser/IPL Core of Knowledge Course, Milton Keynes W: lcsacademy.co.uk 3rd September HealthXchange Obagi Training Workshop, London W: obagi.uk.com

4th - 8th September 21st Congress of the International Society of Aesthetic Plastic Surgery, Geneva, Switzerland 19th - 22nd July European Academy of Dermatol- W: isapscongress2012.org ogy and Venereology Psychodermatology Course, Brussels, Belgium 10th - 12th September Stratum Corneum VII, All W: eadv.org Nations Centre, Cardiff W: stratumcorneum2012.com 20th July Dr Brian Franks Foundation Botulinum Toxin Training Course Part I, London 12th September Skin Laser Applications Course, W: drbrianfranks.com Lynton Clinic Training Centre, Cheadle, Cheshire W: lynton.co.uk 20th - 21st July ORBS Interim Year Meeting: Technical Workshop, Nottingham 12th - 15th September Laser Innsbruck 2012: W: orbsmeetings.com Advances and Controversies in Laser and Aesthetic Surgery, Innsbruck, Austria 20th - 22nd July Aesthetic Surgery / Anti-Aging W: laserinnsbruck.com Medicine: The Next Generation Symposium, The Conrad New York 15th September Cosmetic Courses Foundation W: nextgenmtg.org Botulinum Toxin & Dermal Fillers Training Course, National Training Centre, The Paddocks Clinic, 21st July Dr Brian Franks Foundation Dermal Bucks Fillers Training Course Part I, London W: cosmeticcourses.co.uk W: drbrianfranks.com 15th - 16th September Cosmoderm XIX, 22nd July Introduction to Dermal Fillers & Toxins Mumbai, India Courses, Wigmore Medical, London & W: escad.org Newcastle W: wigmoremedical.com/events 17th - 20th September LCS Academy BTEC Medical Laser/IPL Qualification, Milton Keynes 24th - 25th July SkinBrands SkinCeuticals Training W: lcsacademy.co.uk Course, Ealing, London W: skinbrands.co.uk 17th September SkinGeeks London & Oxford Theory and Practical, London & Oxford AUGUST W: skingeeks.co.uk 1st - 2nd August Eden Aesthetics Agera & Epionce Training, Marriot Renaissance Hotel, Manchester W: edenaesthetics.com

19th - 22nd September 42nd Annual European Society for Dermatological Research Meeting, Venice, Italy W: esdr.org

7th August Sculptra Training Course, Wigmore Medical, London W: wigmoremedical.com/events

26th - 28th September XVIII International Course of Plastic and Aesthetic Surgery of Clinica Planas, Barcelona, Spain W: clinicaplanas.com

11th August Cosmetic Courses Foundation Botulinum Toxin & Dermal Fillers Training Course, National Training Centre, The Paddocks Clinic, Bucks W: cosmeticcourses.co.uk 16th August Advanced Toxins and Fillers Course, Wigmore Medical, London W: wigmoremedical.com/events 22nd August Core of Knowledge Training Course, Lynton Clinic Training Centre, Cheadle, Cheshire W: lynton.co.uk 23rd August SkinGeeks AQ Growth Factor and Stem Cells Training, Wigmore Medical W: skingeeks.co.uk

27th - 30th September 21st European Academy of Dermatology and Venereology Conference, Prague, Czech Republic W: prague2012.eadv.org OCTOBER 3rd October Vascular and Pigment Masterclass, Lynton Clinic Training Centre, Cheadle, Cheshire W: lynton.co.uk 12th - 14th October 8th European Masters in Aesthetic and Anti-Aging Medicine (EMAA), Palais des Congres, Paris, France W: euromedicom.com

23rd - 26th August 4th European Plastic Surgery Research Council Meeting, Hamburg W: epsrc.eu

13th October Cosmetic Courses Foundation Botulinum Toxin & Dermal Fillers Training Course, National Training Centre, The Paddocks Clinic, Bucks W: cosmeticcourses.co.uk

25th August Dr Brian Franks Lips Course (Dermal Fillers Part II), London W: drbrianfranks.com

13th October Microsclerotherapy and Facial Telangiectasia Course, Wigmore Medical, London W: wigmoremedical.com/events

26th - 28th August 6th International DermatoEpidemiology Association Congress, Malmo, Sweden W: idea2012.net

26th - 30th October Plastic Surgery 2012, New Orleans Convention Center, New Orleans W: plasticsurgery.org

31st August Dr Brian Franks Advanced Botulinum Toxin Training Course Part II, London W: drbrianfranks.com

If you have an item you would like included in Training & Events, send it for consideration to editorial@bodylanguage.net

body language www.bodylanguage.net

in frog embryos

Mechanism promising for regenerative medicine A “self-correcting” mechanism in developing organisms has been found to recognise and repair head and facial abnormalities, according to developmental biologists. The process could lead to new reconstructive approaches in correcting birth defects such as cleft lips and microphthalmia (eye abnormalities).

Researchers at Tufts University, Massachusetts, have shown that developing organisms are not genetically hard-wired.

Their study, using a tadpole model with a set of predetermined cell movements resulting in normal facial features, finds cell groups measure their shape and position in relation to other organs and perform movements and remodelling functions to compensate for abnormalities.

Senior researcher Dr Michael Levin says the developmental process is more flexible than once thought. “We found when we created defects in the face experimentally, facial structures move around and mostly end up in their correct positions. This suggests that what the genome encodes ultimately is a set of dynamic, flexible behaviours by which the cells are able to make adjustments to build specific complex structures.

“If we could learn how to bioengineer systems that reliably self-assembled and repaired deviations from the desired target shape, regenerative medicine, robotics and even space exploration would be transformed,” he says.

To make one side of each frog embryo “abnormal”, the team injected specific mRNA

into one cell at the two-cell stage of development, inducing craniofacial defects.

A geometric morphometric analysis was performed to measure the position of 32 facial landmarks. Images taken as the tadpoles aged showed that abnormalities, particularly in the jaws and branchial arches, became less apparent. Eye and nose tissue also became more normal over time.

The study concludes that tadpoles with severe facial abnormalities show a shift in facial structures to repair the malformation. The system seemingly detected deviations and performed corrective actions, said the study authors.

Results showed an information exchange process whereby a structure triangulates its distance and angle from a singular, stable reference point.

The biologists have proposed that these signals, or “pings”, are exchanged between an organising centre—such as the brain or neural network—and individual craniofacial structures.

The researchers say the findings mean congenital malformations of craniofacial structures could potentially be corrected in humans. Further studies at a molecular level will shed more light on the mechanism behind facial changes.

“We were astounded to see that, long before they underwent metamorphosis and became frogs, these tadpoles had normal looking faces. Imagine the implications of an animal with a severe birth defect that, with time alone, can correct that defect,” says Dr Levin.

Abnormalities were induced to craniofacial structures, such as the eye and jaw, which became less apparent as the tadpoles aged 13

peer press review

Peer press review David Williams surveys academic and association journals to report on advances in research A New Umbilical Reconstruction Technique Used for 306 Consecutive Abdominoplasties Validation of a lip fullness scale for assessment of lip augmentation Kane MA, Lorenc ZP, Lin X, Smith SR. Plast Reconstr Surg 2012 May;129(5):822e-8e.

Given the growing use of dermal fillers for cosmetic lip augmentation, a validated instrument with which to measure lip fullness is desirable in the clinic and as an efficacy endpoint in clinical studies. The authors developed and conducted a validation study of a Medicisdeveloped lip fullness scale.

The Medicis Lip Fullness Scale consists of separate fivepoint scales for the upper and lower lips, with three photographs exemplifying each grade.

Five board-certified dermatologists or plastic surgeons assessed 85 test photographs for each lip on two separate occasions for the first round of validation (photograph versus photograph).

Three of the evaluators also graded lip fullness in 39 live subjects, followed two weeks later by scoring of the same subjects’ photographs for the second round of validation (live versus photographic).

Within-observer agreement between the two sequential photographic evaluations was almost perfect (weighted k=0.81).

Between-observer weighted k values ranged 0.60–0.83 for the upper lip and 0.61–0.82 for the lower lip. Exact agreement between the live and photographic assessments of the same subjects was 60% and 52% for upper and lower lips, respectively.

The Medicis Lip Fullness Scale showed high inter-rater and intra-rater reliability in comparisons of test photographs and moderate to substantial reliability in live assessment of patients versus photographs.

14

Cló TC, Nogueira DS. Aesthetic Plast Surg 2012 Jun 4 [Epub ahead of print].

The search for a natural-looking umbilicus that does not compromise the aesthetic outcome of abdominoplasty began in the 1950s and coincides with the period that saw increasing exposure of the female body. Since then, umbilical transposition has been favoured by most surgeons.

This report describes a new technique for umbilical reconstruction using a small X-shaped incision that creates four V-shaped flaps, which are sutured to the aponeurosis with absorbable sutures. This technique was used for 306 consecutive abdominoplasty patients, and a survey was performed to determine their level of satisfaction with the surgical outcome.

A natural-appearing umbilicus was created with no visible scars, a low complication rate (9%), and high patient satisfaction. The technique had a low complication rate and allowed the creation of a new umbilicus with a natural appearance in a rapid, safe and simple manner.

Human embryonic stem cell encapsulation in alginate microbeads in macroporous calcium phosphate cement for bone tissue engineering Tang M, Chen W, Weir MD, TheinHan W, Xu HH. Acta Biomater.

2012 May 22. [Epub ahead of print]

Human embryonic stem cells (hESC) are promising for regenerative medicine applications because of their strong proliferative ability and multilineage differentiation capability. To date there have been no reports on hESC seeding with calcium phosphate cement (CPC).

The objective of this study was to investigate hESC-derived mesenchymal stem cell (hESCd-MSC) encapsulation

in hydrogel microbeads in macroporous CPC for bone tissue engineering. To form embryoid bodies, (EB) hESC were cultured and the MSC were then migrated out of the EB. CPC contained mannitol porogen to create a porosity of 64% and 218-μm macropores, with 20% absorbable fibres for additional porosity when the fibres degrade. hESCd-MSC encapsulated in microbeads in CPC had good viability from one to 21 days. ALP gene expression at 21 days was 25-fold that at one day.

Osteocalcin (OC) at 21 days was two orders of magnitude of that at one day. ALP activity in colorimetric p-nitrophenyl phosphate assay at 21 days was fivefold that at one day. Mineral synthesis by the encapsulated hESCd-MSC at 21 days was sevenfold that at one day.

Potential benefits of the CPC-stem cell paste include injectability, intimate adaptation to complex-shaped bone defects, qne ease in contouring for aesthetics in maxillofacial repairs.

HESCd-MSC were encapsulated in alginate microbeads in macroporous CPC, showing good cell viability, osteogenic differentiation and mineral synthesis for the first time. The hESCd-MSC-encapsulating macroporous CPC construct is promising for bone regeneration.

Daily self-monitoring of body weight, step count, fruit/vegetable intake, and water consumption: a feasible and effective long-term weight loss maintenance approach Akers JD, Cornett RA, Savla JS, Davy KP, Davy BM. J Acad Nutr Diet. 2012 May;112(5):685-692. e2. Epub 2012 Apr 25.

A two-group 12-month weightloss maintenance (WTLM) intervention trial was conducted from June 2007 to February 2010 to determine the feasibility and effectiveness of a WTLM intervention for older

adults using daily self-monitoring of body weight, step count, fruit/vegetable (F/V) intake, and water consumption.

Forty weight-reduced individuals (mean weight lost=6.7±0.6 kg; BMI [calculated as kg/m(2)] 29.2±1.1), age 63±1 years, who had previously participated in a 12-week randomised controlled weightloss intervention trial, were instructed to record daily body weight, step count, and F/V intake (WEV [defined as weight, exercise, and F/V]). Experimental group (WEV+) participants were also instructed to consume 16 fl oz of water before each main meal (three times daily), and to record daily water intake.

Outcome measures included weight change, diet/physical activity behaviors, theoretical constructs related to health behaviours, and other clinical measures. Statistical analyses included growth curve analyses and repeated measures analysis of variance.

Over 12 months, there was a linear decrease in weight (β=0.32, P<0.001) and a quadratic trend (β=0.02, P<0.01) over time, but no group difference (β=-0.23, P=0.08). Analysis of the 365 days of self-reported body weight for each participant determined that weight loss was greater over the study period in the WEV+ group than in the WEV group, corresponding to weight changes of -0.67kg and 1kg, respectively, and an 87% greater weight loss (β=-0.01, P<0.01). Overall compliance to daily tracking was 76% ±5%.

Daily self-monitoring of weight, physical activity, and F/V consumption is a feasible and effective approach for maintaining weight loss for 12 months, and daily selfmonitoring of increased water consumption may provide additional WTLM benefits.

Reviewing the peer press is Body Language editor David Williams

body language www.bodylanguage.net

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surgery Mr Michael Cadier

CHRIS SATTLBERGER/SCIENCE PHOTO LIBRARY

Charting success

Patient being marked up before undergoing surgery for breast enlargement and abdominal sculpturing

Markings in aesthetic procedures are the plastic surgeon’s map to arriving at a good or excellent result, writes Mr Michael Cadier

A

s far back as 800BC, Indian rhinoplasty markings for surgery were described.

Noses that had been cut off as punishments were shown as being reconstructed using a flap of skin from the forehead.

In 1597, Taggliacozzi described a technique to rebuild noses—often sliced off in duels—using skin from the arm. It was only in the 18th century that the Indian

niques have developed and patient expectations have increased.

Where marking is often seen is in patients undergoing liposuction, first described in the 1950s by Illouz. At first, the technique was relatively crude, but now the cannulas are finer, with a diversity of tips for different parts of the body.

A variety of aids— pneumatic, ultrasound and laser—have been developed to refine the technique. Reflecting the preci-



MR MICHAEL CADIER



rhinoplasty, frequently the technique of choice nowadays, was rediscovered.

Today’s plastic surgeon has to be meticulous in the execution of his or her craft. A fundamental part of this is preoperative marking of the surgical site.

Planning is essential in aesthetic surgery where relatively subtle differences determine a poor and a good result, or a good and an outstanding result. Over the past 10-20 years, a wealth of new tech-

16

body language www.bodylanguage.net

surgery Mr Michael Cadier

sion of the procedure is the technique “liposculpture” rather than its less-elegant forebear, liposuction.

Liposculpture involves a careful assessment of the patients’ concerns, an evaluation of the problem, and a plan for the procedure itself. The markings are done with the patient often in a standing position.

The areas to be lipo-sucked are contoured like a geographical map. Zones are added to help ensure underlying structures are not damaged or to show where deep adhesion is required to maintain form. Areas where fat transfer may be required are added.

Finally, the entry points and direction of the cannula’s passage are planned for sufficient cross-tunnelling to create a smooth contour. Although the scars from the entry points are small they are nonetheless carefully planned to hide them in creases, freckles and avoid tell-tale regular scars. Careful pre-operative marking— even in what, at first instance, appears to be a relatively simple procedure such as breast augmentation can be important. If the pocket that is created is too large or incorrectly positioned, the implant will not sit correctly.

If using an infra-mammary approach, positioning the incision in the site of the new crease and not the existing one helps to ensure the scar is inconspicuous and not on the breast itself—the pitfall of an inexperienced surgeon.

The dissection of the muscle may be marked, especially when using a dualplane technique. This produces a more natural appearance and at the same time provides a modest uplift effect.

Facelifts Ageing shows the effects of gravity: the soft tissues are pulled downwards off the facial skeleton. This is made worse by the loss of elasticity in the skin.

Additionally, repeated muscle contrac-

tions stretch the skin and cause crease lines, or rhytides, to occur. As the face ages soft tissues atrophy, in particular, the fat in the cheeks and the temple regions.

Many patients worry they will end up with a windswept appearance—overtight and odd-looking. This may have been true. Facelift markings illustrate how surgery has evolved. New techniques enable surgeons to create a rejuvenated effect while avoiding the classical surgical stigmata.

Modern facelifts address all of these problems by performing multiplanar, volumetric lifts, which are often enhanced by lipofilling. Multiplanar lifts enable the skin and soft tissues to be moved in different directions (or vectors). The skin is usually moved mostly in an upwards direction (correcting gravitational changes), and the soft tissues moved in a vector more inclined backwards.

The MACS-style lifts (first described in 2000) allow a purse-stringing effect on the soft tissues of the cheek that moves not only the jowls upwards and backwards but also brings tissues in from the anterior cheek into the central cheek, frequently hollowed out during ageing. Fat transfer has been revolutionised by the Coleman technique, making lipofilling relatively simple and reliable.

Learning So how does the modern plastic surgeon learn the surgical markings and techniques? In the past, some of this surgery was undertaken in the NHS and mentoring was the rule.

Methods of charting do differ. For tummy tucks, many will eyeball and cut as they go; others do precise 10 x 10cm grids on the patients to ensure precision of excision and closure.

Typical marking tools comprise a specialist marker with a coarse or fine tip and a fine ruler. Incisions may be tattooed, such as for cleft lip repairs or cosmetic ear

corrections where a pre-op tattoo (with a needle) of the cartilage through the skin is undertaken so as to show which portion of the ear cartilage is to be addressed once the skin flaps are elevated. Callipers are used for fine measurements (in eyes) and preformed shapes (in nipple/areola re-siting during breast reductions).

Different colours distinguish areas to be lipo-filled or liposucked, although most of the time colours are employed for demonstration for articles or teaching slides.

Sometimes surgeons have to remark during a procedure. This is most common during mastopexy/augmentation where the markings have always to be adjusted after insertion of the breast implant, which is why it is one of the more difficult procedures, the result really relying on the experience, skill and artistry of the operator.

Fellowships A variety of specialist aesthetic fellowships now exist that teach surgical markings, how to modify them intra-operatively and how they relate to modern concepts in facial and body rejuvenation.

Also, the Royal College of Surgeons has an intercollegiate fellowship programme that enables trainees to be exposed to a variety of speciality groups.

The British Association of Aesthetic Plastic Surgeons has established an on-going aesthetic fellowship for senior trainees. Consultants wishing to hone their skills have regular opportunities to enrol in master classes in facial sculpturing— popular among facial plastic surgeons.

There is little doubt that surgical marking in aesthetic plastic surgery is vital in ensuring that the best possible result is achieved. The challenge for the modern plastic surgeon is the learning and development of these skills.

Michael Cadier, MA (Oxon), FRCS(Plast) is a consultant plastic surgeon



1 For a breast augmentation, the dissection of the muscle may be marked to produce a more natural appearance while providing a modest uplift 2 In the ankle region surgeons avoid the main neurovascular bundle, the fibula bone, and the Achilles’ tendon 3 Surgical markings show the separate vectors to be used, the jowl point that will form the apex of a purse string, and the posterior border of the platysma muscle, which provides a cradle for the neck. This needs to be elevated to correct the sagging body language www.bodylanguage.net

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surgery Mr Alex Karidis

Gynaecomastia, or “man boobs”, is a two-component problem, writes Mr Alex Karidis.

He describes a combination treatment, using power-assisted liposuction with a modified pull-through technique

Gynaecomastia T

he ideal male chest is flat and firm, with skin contoured tautly around well-developed pectoral muscles, leaving a clear masculine appearance. The word gynaecomastia, “female-like breasts”, is originally Greek and was introduced by Galen in the second century AD. The condition is prevalent—around 30–50% of the male population has palpable breast tissue. Statistics compiled by the American Society for Aesthetic Plastic Surgery show that 20,000 gynaecomastia procedures were performed in the US in 2011. In the UK, gynaecomastia was the second most common surgical procedure for men, according to the British Association of Aesthetic Plastic Surgeons.

The condition is unilateral in a third of cases and accounts for around 85% of male breast masses. Gynaecomastia occurs in up to 40% of adolescent boys aged 14–15.5 years. It usually regresses within two years of onset, but a small percentage carry on, either unilaterally or bilaterally.

Approximately 80% of the condition is idiopathic, and considered physiologic.

The other 20% is associated with hormonal and other conditions. Gynaecomastia is caused by transient alteration of the androgen to oestrogen ratio and occurrence is genetically determined.

Some pharmacological agents have been known to cause and induce gynaecomastia, such as those containing oestrogen, those that inhibit testosterone synthesis, finasteride, prescribed for male pattern baldness, and long-term use of marijuana. body language www.bodylanguage.net

Patient history and physical examination are key elements in diagnosing the condition. In general, stable long-standing cases require no routine work-up.

While physical breast examination will obviously produce red flags and the need for further evaluation, laboratory testing is still necessary for patients who find their gynaecomastia is still growing or has suddenly started to grow. Workups are necessary for patients experiencing increased sensitivity, pain or lactation.

Treatment Surgery is still the mainstay of treatment.

Until the 20th century, the submammary lunar incision, as described by Galen, was still in use. But liposuction revolutionised the treatment of gynaecomastia in the mid-1980s. At that time, conventional lipo-cannulas were used. But lipoplasty has evolved and numerous methods now exist to extract or cavitate fat.

Power-assisted liposuction (PAL) uses devices such as the MicroAire system, which comprises a conventional cannula connected to a handpiece.

The electric-driven technique facilitates the procedure. Less force is required, important in areas with more fibrous tissue, resulting in a less labour-intensive procedure. No heat is generated from the tips and the fat extracted can be reused.

The handpiece is heavier than conventional suction-assisted lipoplasty. In some machines, excess vibration can also be transmitted to the practitioners’ hand during use, leading to discomfort.

I use PAL for the fatty component of

the condition. But gynaecomastia is a two-component problem. There is excess fat as well as fibroglandular tissue, with varying degrees of both.

It is not like any other area of lipodystrophy in the body; it needs to be treated differently. Removal of the fatty component of the problem serves only as a means to an end. Lipoplasty facilitates the removal of the glandular or fibroglandular component by exposing it. There is a strong fibrotic element to the fat in the chest, so while PAL is not the only option, it is an effective one.

The key element in successful treatment is removal of the fibroglandular components, which lipoplasty techniques don’t address. Almost all cases of gynaecomastia have a glandular element—no matter how much fat you take out, you’ll still be left with the gland so the patient will still, technically, have gynaecomastia.

So another technique must be used in combination. The gland is dense and won’t cavitate or melt. Numerous techniques have been introduced to minimise traditional scarring associated with gynaecomastia, using small incisions through the armpit or the inframammary crease and combining modalities such as ultrasound, liposuction and endoscopy.

Since 1998, I have treated 548 patients between 17 and 72 years—an average age of 32 years. Patients have an average of 374ml fat aspirated each side, and 13g of fibrogland resection .

Prior to surgery, I mark the patients standing. Nearly 90% of my patients have had the treatment under general anaes19

surgery Mr Alex Karidis

thetic and the rest under local anaesthesia with twilight sedation. I infiltrate these patients using an axillary approach for the lipoplasty, with the arms at 90 degrees.

I use a 4mm incision for the lipoplasty and a 4mm cannula, although on some occasions I will use a 3mm cannula. I perform a thorough sectioning of the marked areas until the fibroglandular component is effectively “uncloaked” or denuded.

You can palpate it underneath the skin with your hand.

I use a modified pull-through method to remove the fibrogland via an 8–10mm periareolar incision at the 6pm position in all my patients, except those with massive weight loss, who require skin resection and/or nipple graft.

Undermining Following incision, I undermine everything around the area using tenotomy scissors. I go down to the pectoral fascia and release the gland from the underlying fascia. This is facilitated by the previous liposuction.

Once free, segments of the gland are pulled through the incision. We don’t

suture the incisions and place the patient in compression garments immediately afterwards. Average operating time is around 35 minutes. It’s important to assess the skin tone. Obvious skin flaccidity with marked thinning and history of past weight loss means you have to look at the position of the nipple areola complex.

If this is not significantly ptotic, I would perform the same technique but more conservatively, leaving a thicker skin fat flap and less aggressive gland removal. But I do explain to these patients that volume removal will be more limited. Don’t forget, these patients are sensitive about this condition, and they want a flat chest. If the nipple areola complex is grossly ptotic, I would add some form of skin excision to the procedure.

Skin contraction is important. The majority of patients will contract, providing enough tissue is removed to allow contraction. If you leave behind pockets of fat, it won’t be able to wrap and redrape. Disruption of the fibrous bands beneath the skin is important, as is excision of fibroglandular tissue, and PAL is a good tool for this.

Before and four months after PAL and pull through technique, extracting 575ml fat and 65g fibroglandular tissue each side

Before and five months after treatment, extracting 650ml fat and 75g fibrogland each side

Preop and five months after aspiration of 225ml fat and 101g fibrogland

Visible scarring is minimal, as the technique is performed through small incisions in the armpit and directly under the areola.

20

In this area of skin tightening, skin contraction is technique-dependent rather than technology-dependent. The patients can contract when the operation is performed properly.

Tips My advice is to aim for a flat result but do not skeletonise the skin entirely. Leave about 6–7mm of fat on the underside.

You hear reports about nipples and areola caving in, so make sure you feather out the edges. If you leave a ring of fat around the areola, you will get a discrepancy, or “step off”. If you feather the fat, you’ll be fine.

Stay off the pectoralis major fascia.

If you start disrupting this, you can get tethering and consequent problems on the overlying skin. You can sometimes get wrinkling of the nipple areola complex and tethering at the areola incision but these always settle down.

Always open up the areola to look for the gland. Even if you’re tempted not to, make sure you do so. You’re always going to find something. Even if it’s 2–3g of gland, and you miss it, that patient will come back to haunt you to say they’re not happy with the result. Leave 2–3mm thickness under the areola.

Always do a second, third and fourth survey after liposuction. If you think you’re finished, go back in, have a look and see if you’ve missed anything.

Pay particular attention to the lateral sides, as you will get displacement when the patient is supine, and tissue can be missed when it falls to the sides. Otherwise, the fat will move back into place when the patient stands up and they won’t be pleased with the result. Despite temptation, do not suture the incision sites.

As for complications, I’ve seen nine haematomas in the last 13 years, which required evacuation. Nowadays, we evacuate them in outpatient. You can manually compress them and the patient doesn’t feel it, so you don’t need to take them back into theatre. We have seen one major infection and 12 revision surgeries—a 2.2% touch-up rate.

By combining PAL with a modified pull-through technique, we have corrected gynaecomastia and provided good body contours in 98% of our patients.

We’re able to minimise scarring in those who do not require skin excisions and can get good contraction of the skin if the procedure is performed properly.

Mr Alex Karidis is a cosmetic surgeon who works from the Hospital of St John and St Elizabeth in London body language www.bodylanguage.net

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psychology Dr Raj Persaud and Dr Peter Bruggen

Turn that frown upside down Dr Raj Persaud and Dr Peter Bruggen report on research that injected botulinum toxin for alleviating symptoms of depression

W

e look upset because we feel distraught. But how often have we intuitively felt that if someone just tried to look happier, it might have a positive impact on their mood? Could it be that looking sad contributes to low mood? This would have revolutionary implications for understanding the causes of low mood and the treatment of depression.

Botulinum toxin injections are one of the most common procedures in aesthetic medicine. The toxin inhibits corrugator and procerus muscle activity, or the treatment of frown lines.

Two teams of researchers led by Axel Wollmera and Tillmann Krugerb, based in Switzerland and Germany, have turned conventional thinking on its head. The study, published in the Journal of Psychiatric Research, has found that by injecting botulinum toxin into the glabellar region, the symptoms of depression can be alleviated.

Critics of such studies say that it’s not the Botox that cheers us up, it’s the aesthetic impact—we look better than we did before, so we’re happier. However, the subjects recruited for this study were suffering from long-standing clinical depression. Patients had, on average, a 16-year history of clinically low mood.

The individuals were also selected because of their lack of concern over facial appearance; given the choice, they would not have chosen to have Botox treatment.

Trial The study, “Facing depression with botulinum toxin: A randomized controlled trial”, involved patients who had not benefited from standard anti-depressant prescription medication.

In 15 patients, botulinum toxin was injected once into the glabella. Another 15 were injected with placebo salt water. Improvements in mood were achieved after just one injection. Six weeks after a single treatment, scores on a standard depression rating scale for those injected with the toxin were reduced on average by 47.1%. The placebo-treated group experienced only a 9.2% reduction in the measurement of their depression.

The researchers chose two specific muscles in the face to inject into—the corrugator supercilii and the procerus. These muscles are particularly associated with negative expressions.

The first is responsible for pulling the eyebrows down, producing vertical wrinkles on the forehead, and is the key muscle in expressing distress. The procerus pulls the skin between the eyebrows down, is associated with transverse forehead lines and is particularly targeted for the correction of wrinkles.

This part of the face has long been linked to depression.

Since the Victorian era, the “omega” sign of depression—or omega melancholicum—features wrinkling of the skin above the nose and between the eyebrows, resembling the Greek letter omega, or Ω. This omega sign was believed to be diagnostic of a depressive disorder. body language www.bodylanguage.net

William James, a psychology professor at Harvard University, referred to a facial feedback hypothesis by saying, in 1890: “Refuse to express a passion, and it dies”. Wollmera and Krugerb argue that this suggests strong historical support for mutual interaction between emotions and facial muscle activity, rather than just one-way traffic.

Expression To test the idea that by expressing an emotion we feel that mood, recent scientific studies have aimed to alter facial expression and investigate if emotional experience is subsequently affected. To ensure scientific credibility, these studies must manipulate facial emotion while eliminating or minimising the participants’ awareness they are being asked to produce an emotional expression.

For example, one experiment involved subjects holding a pen between their teeth. They were producing a simulation of smiling without the subjects being aware that this was the point of the experiment. The expression caused them to find cartoons funnier.

In another study, golf tees were attached to either side of a subject’s forehead. The participants were asked to move the two tees closer together, producing a simulation of frowning, without the subjects realising they were being asked to glower. When the tees were closer together, subjects rated unpleasant photographs more negatively.

The authors of the toxin study speculate that the treatment may act comparably to a relaxation exercise. In which case, patients wouldn’t need Botox to get the benefits of this treatment.

They could just learn relaxation techniques and apply them specifically to their facial muscles.

Another theory about the study’s results could be that a more positive facial expression improved social interaction, contributing to improved mood. By looking in the mirror, subjects may have felt they looked more cheerful. This could have led them to believe they were happier which, in turn, elevated mood.

However, a purely aesthetic benefit can be excluded as the reason for mood improvement, argue the authors, because the selected patients were not concerned about the appearance of their frown lines. The improvement in mood found was not caused by feeling better about an improvement in appearance. One participant’s depression remitted with the botulinum toxin treatment but they, in fact, disliked the facial appearance it produced.

The authors conclude that their clinical trial shows facial expressions associated with depression are not just the consequences of clinically low mood. Negative expressions may be integral components of the disorder, and can be targeted in an entirely new approach. Learning to smile more or frown less may just be the latest scientifically validated treatment for depression.

Dr Raj Persaud is a consultant psychiatrist in private practice. Dr Peter Bruggen is a retired consultant psychiatrist 23

clinical Anthony Erian

Lip reading Filling out the lips requires good technique and an appreciation of their geometry.

Mr Anthony Erian discusses how he produces beautiful aesthetic lips

L

ip surgery is among the more difficult challenges. The criteria of beauty for the lips include a fuller look, symmetry, contour definition, and a slightly protruding Cupid's arch. Lips should represent youth, romance and beauty.

The lips are the shape of a soft M for the upper (labium superius) and a W for the lower lip (labium inferius). The lower lip is usually larger.

The border between the lips and the surrounding skin is referred to as the vermillion border, or simply the vermilion. The vertical groove on the upper lip is known as the philtrum. The skin of the lip, with three to five cellular layers, is very thin compared with typical face skin, which has up to 16 layers.

The lip skin contains fewer melanocytes—cells that produce melanin pigment—which is why lips have light skin 24

colour. The blood vessels appear through the skin of the lips, which leads to their notable red colour. This is less prominent with darker skin, because the skin of the lips contains more melanin and appears more dark.

The skin of the lip forms the border between the exterior skin of the face and the interior mucous membrane of the inside of the mouth. As the lip skin is neither hairy nor has sweat or sebaceous glands, it does not have the usual protective layer of sweat and body oils, which keep the skin smooth, inhibit pathogens, and regulate warmth. For these reasons, the lips dry out faster and become chapped more easily. The basic parts of the mouth and lips are: • upper lip (labium superfluous entafada)—the strip of smooth skin that borders the upper edge of the mouth. It is usually thinner than the lower lip and

can have pronounced peaks to either side of a groove at the centre of the mouth.

• lower lip (labium inferius)—the strip of smooth skin that borders the lower edge of the mouth. It is usually wider and vertically deeper than the upper lip.

• vermilion—the border of the skin of the lips and the surrounding skin of the face. In some individuals this is more pronounced; in others the two skin types seem to almost blend. For contouring, inject the vermilion border.

• Cupid’s bow—the area in the middle of the upper lip, which straightens with age.

Carefully placed dermal filler can restore the youthful look of the Cupid's bow.

• philtral columns—the groove-like indentation often found at the centre of the upper lip. It is responsible for the biggest difference in shape between the upper and lower lips and becomes more pronounced when the mouth is puckered. This is an body language www.bodylanguage.net

clinical Anthony Erian

especially important aspect of the lip that requires attention during treatment. For correction, inject directly into the subdermal layer • dry part—the part under the lip that separates the dry and wet part and is usually used for fullness. For fullness, inject the dry part of the inner lip.

• wet part—adjacent to the dry part and is important for pouting. To accentuate or restore pouting, inject the wet part of the inner lip.

The oral commisure requires separate injection.

Ageing lips show a loss of lip projection, lengthening of white lip, flattening of philtrum, flattening of Cupid’s bow, dermal and subcutaneous atrophy, and atrophy of orbicularis oris.

To achieve a balanced lip size, the ratio of the height of the upper lip to that of the lower is ideally 1.4:1.6. body language www.bodylanguage.net

Technique Good anatomical knowledge of the nerve supply is vital to the success of the local.

The infraorbital nerve is a branch of the maxillary trunk. It supplies not only the upper lip but also much of the skin of the face between the upper lip and the lower eyelid, except for the bridge of the nose.

The mental nerve is a branch of the mandibular trunk (via the inferior alveolar nerve). It supplies the skin and mucous membrane of the lower lip and labial gingiva (gum) anteriorly.

My kit includes sterile gloves, a magnifying light, and a mirror. I use betadine antiseptic solution to clean the area. I apply Emla cream local anaesthetic to the lip and skin surrounding the lips about 30–60 minutes before the procedure. I perform a complete dental block, which is vital to the procedure, as lip rejuvenation is painful. I inject with hyaluronic acid (HA) fillers, which are based on a natural part of the extracellular matrix of bone and cartilage. HA fillers absorb water and form a gel, which creates volume and degrades over 9–12 months.

Fat transfer techniques have been used to produce aesthetically appealing lips, but there is steep learning curve to this technique. We prefer the Pearl technique, which injects small aliquots of fat parcels in multiple layers. I do not recommend non-absorbable material or Gortex, as they can produce long-term complications.

I perform an intramuscular injection using a very fine needle on a Luer-lock syringe. In the upper lip, I insert the needle into the mucosa and point upwards on either side of the philtrum to fill Cupid’s bow and obtain slight eversion. The remaining upper lip is injected through injections at corner of the lips at a 45 degree angle, progressing slowly towards the midline and philtrum.

For the best results, inject the filler superficially (under the dermal layer).

When approaching the Cupid's bow or arch, do so from the inferior direction; otherwise, it creates inversion of the lip.

In the lower lip, I insert the needle in similar positions to the upper lip. The lip margins are injected superficially to achieve contour definition. I inject parallel beneath the skin, with slow injection on withdrawal to obtain uniform distribution. Each injection deposits about 0.1cc of injectable material. This will achieve eversion of the vermilion border, enhance convexity, produce fuller lips, and produce a more youthful appearance because of the improved philtrum and Cupid’s bow.

You can gently massage the injected areas afterwards. The patient will be able

to see the result immediately, which is an additional benefit. A touch-up may be considered at anytime.

Be mindful of the arterial supply to avoid bruising, because the lips have a rich blood supply. The facial artery is one of the six non-terminal branches of the external carotid artery. It supplies the lips by its superior and inferior labial branches, each of which bifurcate and anastomose with their companion artery from the other side.

Sometimes the lips may swell and be red for 1–2 days; however, when this occurs it is minimal and can be camouflaged with make-up. Clients may continue to work and socialise. No antibiotic or antiviral treatment is required. Ice packs for 24 hours may be used to reduce swelling, and simple pain medication such as Paracetamol may be taken if necessary. Very rarely do complications occur, but those that do are infection, allergic reaction, persistent erythema, lumps and bleeding.

Other rarer complications for implantable materials include seromas, malposition, infection, extrusion, long-term inflammation and capsule formation.

Lip augmentation can be performed alone or with facial surgery. Operative procedures may be considered. This includes operations that involve advancement, lift and roll techniques. The complications, however, may be significant and hypertrophic scarring, asymmetry, numbness, and lumpiness may arise.

Mr Anthony Erian is a plastic surgeon and is on the Body Language editorial panel

Before and after injecting the lips with HA 25

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Precision in practice

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MICROMEDICS

laser Dr Tapan Patel

Burns scar revision Traditional ablative laser treatments for scarring are well documented but have a history of side effects and extended downtime. Dr Tapan Patel discusses the use of fractional CO2 laser for treating burns scars

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asers can be used to manipulate the texture, appearance and structure of mature scars caused by thermal burns or surgery. Dr Jill Waibel, medical director at Miami Dermatology and Laser Institute in Florida, was one of the first doctors to pioneer the treatment. Among her first patients were a set of triplets who, as children, were involved in a house fire and sustained third-degree burns. Dr Waibel performed a series of treatments with significant cosmetic and functional improvement.

At the same time, doctors at the San Antonio Air Force Base and the San Diego Naval Base were developing the treatment on wounded military personnel injured in Iraq and Afghanistan.

It has two handpieces: ActiveFX provides a large 1.3mm spot size, and DeepFX a much smaller 120μm spot. The smaller beams penetrate further into the skin.

In determining the parameters, we need to consider the following factors: • Pulse width (PW). This refers to the time over which the total energy is delivered. If the PW is too long, there is less ablation and more coagulation and, possibly charring, of the tissue. Accordingly, we need the PW to be as short as possible. The UltraPulse has an extremely short PW which allows for an ideal ablation to coagulation ratio.

• High energy. Scar tissue is thick and to penetrate this adequately, we require a high energy. The Ultrapulse is a 240W Ablation laser and there is in development a handpiece which will The two main technologies used are CO2 (10600nm) and allow 150mJ per spot and up to 4mm penetration into the Er:YAG (2940nm) lasers. These ablative lasers produce outputs tissue that are strongly absorbed by water. With water as the chromo- • Density. This refers to the spacing between the individual phore, the laser energy results in instant vapourisation of the beams. For scar treatment a low density is preferable to avoid skin on impact. These lasers bulk heating of the tissue. have been extensively used to We typically employ a high resurface skin that has been energy, short pulse width, low damaged by photoageing or density pattern. The effect of acne scarring. the laser is to create holes in the Results seen with traditionscar that act as a mechanical al ablative lasers for rejuvenafenestration—similar to skin tion were impressive. But they needling. These holes appear were associated with signifito relax tension in the scar. cant side effects and downtime Biopsies have shown that because of the severity of the these channels can be populatinjury produced. This type of ed by normal tissue. The chandevice would not be useful in nels can also be used to deliver treating mature burns scars. drugs such as topical steroids.

The original continuous Heat in the skin activates wave CO2 lasers produced a heat shock proteins which have total loss of skin in the treata role in the wound repair procment area, leading to sideess. This activation produces effects, complication rates and more collagen synthesis and longer healing. The concept less collagen breakdown. of fractional photothermolysis A paper published in 2011 was a breakthrough in how lashows that, if you compare patThe laser creates holes in the burn scar, acting as a mechanical fenestrasers could be used. Fractional tion. Before and after treatment, showing the fractional injury appears terns of wounding with laser systems divided a beam into to relax tension in the scar, allowing for the mouth to open further energy, scalpel and needling, a number of smaller beams— the laser produces the most sigonly a fraction of the skin is treated and the untreated skin can nificant heat shock protein up regulation. allow more rapid healing.

Researchers in America looked at the histology of burn scars For scars, I use the Lumenis UltraPulse fractional CO2 laser. after laser treatment and found an inversion of the collagen ratio, body language www.bodylanguage.net

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laser Dr Tapan Patel

Katie Piper sustained major chemical burns to her face, neck and chest, resulting in severe scarring and a thick contracted scar limiting her neck movement

KATIE PIPER PHOTOS: DR MATTEO TRETTI CLEMENTONI

Before and after the second laser treatment. The contracture was improved, and Katie reported easier movement with neck flexion and rotation

Before and after three laser procedures, showing a 7 degree improvement to her assymetric smile

Laser treatment provided a 5mm functional improvement in ectropion in Katieâ&#x20AC;&#x2122;s left eye 28

with a return towards the ratio found in normal, healthy tissue.

This whole concept is a real paradigm shift. A laser previously used to tighten and contract elastotic skin can now be used in a contracted scar to lengthen it. In other words, whether it is elastotic, sun-damaged, or hypertrophic scarred skin, fractional injury will steer it towards a more normal pattern.

The procedure has a high safety margin and itâ&#x20AC;&#x2122;s well tolerated.

In over 4000 treated patients in America, almost all reported some improvement, both cosmetically and functionally. That improvement appears accumulative, with repeat treatments.

Treatments are generally performed two months apart. The procedure is also quick to perform and requires only topical anaesthesia and cooling for the majority of patients.

There are some issues regarding the treatment that patients will need to be counseled on. If someone has sustained a thermal injury, it must be explained that we will be inducing another thermal injury to treat the original burn, which may be upsetting for the patient.

Patients may be able to smell the burnt skin during treatment, and this can potentially provoke post-traumatic stress. Additionally, patients often have altered anatomy physiology and pain mechanisms.

Katie Piper Katie was the victim of a savage acid attack which resulted in her sustaining major chemical burns to her face, neck and chest.

Her immediate treatment was at Chelsea and Westminster Hospital under the care of consultant plastic surgeon, Mr Mohamed Jawad. Mr Jawad introduced Katie to myself and my colleague Dr Matteo Tretti Clementoni, a plastic surgeon from Milan. Dr Clementoni is one of the most experienced laser practitioners worldwide and initially trained me on the UltraPulse. Katie had the laser treatment in London and Dr Clementoni and I performed three procedures.

When we first met her, one of the limitations was the thick, contracted scar that was limiting her neck extension and giving her an asymmetric smile. The contracture went down to her chest. We used a high energy and low density setting for these contracted scars. Where we wanted to retexture, we increased the density followed by an all-over resurfacing.

After one treatment, we could appreciate a subtle but definite improvement. This was confirmed by Katie who reported improved range of movement with neck flexion and rotation. The results improved with the second and third treatment.

Before laser treatment, she had a degree of ectropion in her left eye, and afterwards she had a 5mm improvement. Her asymmetric smile was straightened, with a seven-degree improvement after three treatments.

Katie has been a true survivor in every sense and has founded the Katie Piper Foundation, which provides help and support for burns victims, some of whom have come to our clinic for laser treatment. This treatment is still at an embryonic stage and there is still a lot of work to be done to establish parameters and protocols. It is vital to bear in mind that scars can be worsened if the parameters are too aggressive and not all systems will be suitable to perform the treatment.

Although the results may appear subtle, just a few millimeters increase in range of motion in a limb can be the difference between a patient requiring feeding or rediscovering some independence.

Dr Tapan Patel is a physician with an interest in dermatology. He is also founder and medical director of VIVA clinic in London body language www.bodylanguage.net

advertorial SkinCeuticals

Inside and out photo protection SkinCeuticals, a leading authority in antioxidant skincare, offers scientifically proven protection against photo damage by combining a sunscreen with a topical antioxidant

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o help protect the skin during sun exposure, SkinCeuticals has developed potent antioxidant formulas that have been scientifically proven to provide significant photo protection against UVA stress in skin.

The true pioneer of antioxidant serums and state-ofthe-art, serum-in-a-gel technology, SkinCeuticals’ topical antioxidants have been scientifically evaluated and proven to neutralise free radicals caused by UV exposure and other environmental sources.

In addition, they prevent the formation of thymine dimers, UV-induced collagen breakdown and help diminish the appearance of photo ageing.

Phloretin CF Gel Revolutionising the texture of SkinCeuticals topical antioxidants while maintaining the integrity and efficacy of the original serum formula, Phloretin CF Gel is the latest offering by the leading antioxidant brand. Formulated with an optimised acid combination of 2% phloretin, 10% L-ascorbic

acid and 0.5% ferulic acid, this serum-in-a-gel protects skin from reactive molecules created by environmental insults, known to cause DNA mutations and damage among the integral cell types.

As supported by clinical studies, the phloretin molecule enhances the efficacy of vitamin C and ferulic acid for increased synergy while regulating pigment production.

This trusted antioxidant trio accelerates cell turnover and stimulates collagen synthesis to boost skin’s structure for a firmer, brighter complexion.

The state-of-the-art gel technology allows actives to be suspended in a gel matrix at an acidic pH to penetrate skin down to the target site, just like an aqueous serum.

On contact with the skin, the serum is released from the gel matrix in a controlled manner and driven down to the target site for maximum penetration.

This slower delivery system makes Phloretin CF Gel ideal for those with more sensitive skin types, as well as those who prefer a gellifer format.

Protective state-of-the-art UV filters Like the rest of the SkinCeuticals line, the Protect range of sunscreens has cutting edge formulations to ensure maximum efficacy: l Broad-spectrum protection available in a variety of textures. l Dual protective and corrective properties. l Fragrance-free and high tolerance formulas to suit even the most sensitive skins.

They contain state-of-the-art UV filters Mexoryl SX and XL, providing superior, photo stable protection against short and long UVA rays.

Mexoryl SX and XL works synergistically with octinoxate and titanium dioxide to deliver broad-spectrum UVA and UVB coverage that contains reduced sun filter chemicals.

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Formulation constraints met Until now, due to formulation constraints, only an aqueous serum met the strict Duke antioxidant parameters: l Must contain pure L-ascorbic acid, the chrially correct form of vitamin C. l Must contain a high concentration of L-ascorbic acid, between 10-15%. l Must be formulated at an acidic pH, ideally between 2-3.5.

Typically, gelifiers cannot be formulated at a low enough pH to conform to these constraints. However, SkinCeuticals has unveiled new serum-in-a-gel technology that allows actives to be suspended in an acidic pH solution while still meeting the strict vitamin C parameters established by Duke University research.

Effectively formulated antioxidants can help neutralise UV-induced free radicals not blocked by sunscreens.

Protection from UV light is required all year round and sunscreen is always the first line of defence from the harmful effects of the sun. However, sunscreens alone can provide only a maximum of 55% protection from free radical attack. Therefore, a complete preventative programme is required containing a topical antioxidant and a broad-spectrum UVA/UVB SPF. Brightening UV Defense PF30 SkinCeuticals new Brightening UV Defense SPF30 is designed to provide year-round UVA and UVB protection in an elegant formula providing up to 12 hours’ hydration. It has dual protective and corrective properties, protecting skin from the range of UV rays known to cause unwanted pigmentation and accelerated ageing, while correcting existing signs of skin discolouration to encourage a brighter, smoother and more radiant complexion.

Fragrance-free and suitable for all skin types, Brightening UV Defense SPF30 is enriched with mint extract. The formulation works to dramatically improve the uneven, dull appearance of photo-aged skin caused by prolonged sun exposure and excess melanin production.

It has a lightweight, hydrating texture that contains the HyperBright Complex, a compound targeting hyperpigmentation that reduces excess UV-induced pigmentation by 42.9%, while preventing future pigmentation.

For adequate protection from the damaging effects of sunrays, a comprehensive programme including an antioxidant and sunscreen is required. When used together, they help to provide up to 96% protection against the harmful effects of the sun and combat the reactive oxygen species UV light creates, a defense from the premature skin ageing that the sun is known to cause.

For further information call SkinCeuticals on T: 020 8762 4987 29

insurance Eddie Hooker

How much for cover?

Insurance premiums are always a source of much discussion.

Eddie Hooker discusses how insurance companies calculate the premiums they charge for policies

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he difficulty for commercial risktakers is where they pitch their pricing and whether certain treatments are already protected by the defence organisations, thus duplicating the separate policy’s cover. However, both the MPS/DDS and MDU/DDU now make clear distinctions on their membership rates and procedure exclusions for their sectors of the medical profession.

The problems are not limited to professional practitioners. Many beauty salons and beauticians/therapists regularly purchase often inadequate cover, thinking that they have full-blown medical malpractice insurance when, in many cases, the protection provided is limited to certain low-risk procedures or excludes cover for advice and financial loss.

In most cases the issue boils down to how much the practitioner is willing to pay for his or her protection. Defence organisations normally charge a premium membership fee for practitioners undertaking cosmetic procedures and scales of charges depend on the amount of work performed and the types of procedure undertaken.

Therefore, a practitioner whose main income is derived from aesthetic procedures may find that paying the higher membership fee is more beneficial than buying top-up insurance from a commercial provider. But as stated many times in previous articles, you must check that the procedures that you perform are covered by your membership scale.

When setting premium rates for aesthetic procedures, insurers look at various risk indicators. New products and procedures entering the aesthetic market are increasing all the time. Many products are derivatives or the re-branding of older, better established products; some are variations on a theme. However, insurers are not generally medical experts, and their understanding of these products is crucial to their view of the risk presented to them.

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Insurance is broadly based on historical data and, in the case of aesthetic medicine, evidence of credible clinical trials are of paramount importance if an insurer is to accept and place a price on insuring the procedure. Too many products are brought to market without this information and without a thought for insurance for the practitioners who are to use them.

The marketing and use of a product with unknown long-term side-effects become the problem of insurers many years down the line when claims start to come in. There are many examples of problems with products without formal or robust clinical trials. However safe the product is thought to be by sectors of the medical profession, insurers and defence bodies often refuse to provide protection. Evidence of safeness and honesty in the success of the procedure is essential.

Competence Of equal importance to an insurer is who the product is sold to and the competence of the practitioner using it. Medical malpractice policies insure the practitioner, not the product, although as discussed, the safeness of the product is considered.

Recent bad press experienced by several procedure trainers highlighted the problems facing the cosmetic industry and why government legislation and regulation is only a matter of time.

Practitioners, for a modest fee, can be trained in a new procedure in a short period, and in many cases the understanding of the product and procedure are not correctly assessed by the trainer.

Cosmetic training courses are easy to set up. In some instances they are conducted by practitioners who, themselves, have only just completed their training course.

There are no common standards employed by training courses and no independent assessment of the course tutors, let alone the structure of the course.

Beauticians, who are used to undertaking procedures such as facials, manicures, massage and the like, can be trained in the use of a laser machine in as short a time as one day. However safe the equipment is deemed to be by the manufacturer, in the wrong hands they can prove dangerous.

Insurance itself is now a heavily regulated industry and its own managers and trainers have to be proven competent by industry organisations and external bodies. It is a natural evolution that insurers will expect the industries that it insures to follow the same or similar assessment.

Insurers have a good understanding of the costs of litigation—after all, it’s their day job. Most claims are predominantly made up of litigation costs. In the majority of claims, it is the lawyers that walk away with the most money.

Cosmetic techniques are relatively expensive and are used in elective procedures. The patients or clients that request these treatments tend to be a self-selecting group with sometimes high and unrealistic expectations. These factors taken together represent an above average potential for litigation.

While evidence points to most aesthetic procedures to be safe, should something go wrong the results can often be catastrophic. Insurers need to build a pool of premiums to protect their exposure when, eventually, a large claim is presented.

Many of these claims are “long-tail” with evidence and counter evidence commonly taking months and sometimes years.

For insurance premiums or membership costs to slow their increase or to start to reduce, the cosmetic and aesthetic industry needs to start to improve its standards and provide more concise and understandable information to the insurance industry and patients alike.

Eddie Hooker is chief executive officer of Hamilton Fraser Cosmetic Insurance body language www.bodylanguage.net

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regulation Helen Twinam

Called to account Misinformation abounds in medicine’s regulatory circles, particularly pertaining to the safety of approved devices.

Helen Twinam delves into European and American medical regulations to report on how they promote safety

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harges of over- and under-regulation of drugs and medical devices are often aimed at regulators, Industry scandals such as PIP do little to help foster understanding. In the US and Europe—the two largest markets for medical products—authorities are working hard to improve regulatory practices, and filling gaps uncovered by past mistakes.

The Food and Drug Administration (FDA) regulates pharmaceutical drugs, food safety, dietary supplements, vaccines, medical devices and cosmetics across the US. As defined by the agency, a drug is any product intended for use in the diagnosis, cure mitigation, treatment or prevention of disease, and that is intended to affect the structure or any function of the body.

In 2011, the FDA approved 35 new medicines; the second highest number of approvals in the past 10 years.

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Drug manufacturing companies import products from all over the world, and so regulation must extend to all aspects of the drug production cycle. A 2012 FDA Global Engagement report has signalled the regulator’s intention to become a global public health agency, rather than a domestic one, by gathering coalitions of local regulators into a world-wide product monitoring forum.

Active pharmaceutical ingredient (API) production has shifted in recent years to Asia and, according to the FDA, imports of pharmaceutical products to the US from 2005 to 2011 doubled.

China, India and Eastern Europe have the largest number of FDA-registered drug manufacturing companies outside the US. These countries offer low-cost products but, with the move, the FDA will try to ensure conformance with API good manufacturing practice. body language www.bodylanguage.net

regulation Helen Twinam

The FDA has established 13 foreign posts to improve global drug quality, but more robust regulation requires cooperation between partnering countries. The FDA’s move will result in more regular site inspections by local regulators, as well as the European Medicines Agency (EMA) and FDA, and adherence to international standards.

FDA approval Drug manufacturers seeking FDA approval must first test a new drug on animals for toxicity, followed by submission of an Investigational New Drug (IND) application. The FDA reviews the IND to ensure that proposed human trials do not place human subjects at unreasonable risk of harm.

Clinical studies take place in three phases. The first, which focuses on safety, uses 20–80 healthy human volunteers to determine the drug’s side-effects. Phase two involves larger groups to find out the drug’s effectiveness on subjects with a certain disease or condition. Patients receiving the drug are monitored and the data compared with that of patients taking a placebo.

The final phase involves large-scale studies on thousands of patients, with different populations and dosages, and combining it with other medicines. The manufacturer then submits a New Drug Application (NDA) to the FDA, which includes trial data and manufacturing information. Following review, product packaging and labelling are checked and manufacturing facilities are inspected. If satisfactory, the application is approved.

Post-marketing monitoring requires that the agency is advised of any unexpected or serious adverse events through submission of periodic safety updates.

The drug is approved for a specific indication but can be legally used to treat other indications, otherwise known as offlabel. Botox is a prime example—there are many off-label uses for which the injectable has been proven effective.

Manufacturers cannot, however, market the drug for any indication other than the one for which it is approved. In 2010, Botox Therapeutic manufacturer Allergan agreed to a $600 million settlement over charges that it illegally promoted the toxin for unapproved uses.

In the UK, doctors are also legally allowed to prescribe medicines off-label. But General Medical Council guidance states that practitioners must be satisfied there is no better alternative and that there is a sufficient evidence base to demonstrate its safety and efficacy.

In the US, biological therapeutic agents—otherwise known as blood products, gene therapy, vaccines, cell and tissue-based products—are dealt with by the Center for Biologics Evaluation and Research. New biologics follow a similar approval process to drugs.

Cosmetic products are not subject to FDA approval and are regulated by the same agency branch that governs food regulation. But the rise in popularity of cosmeceuticals, which combine topical cosmetics with pharmaceuticals, have attracted criticism and required clearer definition by the FDA. The Food, Drug and Cosmetic Act does not recognise the term. “A product can be a drug, a cosmetic or a combination of both, but the term “cosmeceutical” has no meaning under the law,” states the FDA. “While drugs are subject to an intensive review and approval process by the FDA, cosmetics are not approved prior to sale. If a product has drug properties, it must be approved as a drug.”

When cosmeceuticals first appeared on the market, consumers assumed they had passed the rigorous FDA safety testing assigned to drugs. The agency now requires that these products do not market themselves as containing drug properties unless body language www.bodylanguage.net

substantiated by scientific evidence and having undergone appropriate testing and approval as a drug.

The FDA has undergone much scrutiny and has been accused of both under- and over-regulation. Ultimately, though, the agency must ensure strong regulation within a short timeframe. Patients losing their lives, owing to delays in the drug approval process—particularly during the 80s’ AIDS epidemic—has led to expedited approval for drugs used to treat serious diseases or to fill a medical need. Drug effectiveness can be based on a surrogate endpoint, such as a blood test or x-ray, or portions of the application can be submitted as the information becomes available.

Medical devices Medical devices comprise a huge range of products, from bandages to laser platforms. The FDA’s Center for Devices and Radiological Health (CDRH) regulates and monitors manufacturers and importers of all medical devices on the US market.

There are three classes for medical devices, for both FDA and Europe—I, II and III—each requiring different control and assessment. In America, class I devices, such as bandages or latex gloves, require the least regulation, because they have been shown to present little risk of illness or injury. Class II devices are subject to extra controls such as labelling requirements and post-market surveillance.

Class III devices need an additional premarket approval (PMA)—akin to a new drug application—involving a scientific review. These devices are categorised as those that support or sustain human life or present a significant risk of illness or injury to the patient.

If a new device is deemed similar to a device already on the market, it can be submitted through a premarket notification, also known as a 510(k). Fast-tracked products reaching the market as Class II devices through a 510(k) are not considered approved by the FDA but can be marketed and sold across the US. According to the agency, around 90% of medical devices on the US market are cleared through the 510(k) process.

However, no clinical evidence is needed to prove the product’s safety and, as critics have pointed out, many of the products Class III devices, such as breast implants, need additional premarket approval akin to a new drug application

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regulation Helen Twinam

Approval for new drugs involves three phases of clinical trials, focusing on safety, effectiveness and dosage

used for comparison have never received safety reviews themselves. A 2011 report by America’s Institute of Medicine (IOM) heavily criticised the 510(k) clearance process, stating that, while the process speeds up evaluation of class II devices, it does not provide a reliable premarket screen of device safety. They called on the FDA to develop a new framework using premarket clearance and improved postmarket surveillance for class II devices.

While the IOM suggested a regulation overhaul, others have suggested raising review fees in line with those for drug applications, to cover expenses needed for a more thorough review process. A new drug application costs around $1.8 million and a PMA $220,050; a 501(k) pre-notification costs just over $4,000.

The FDA has no plans to get rid of the 510(k) but has recently amended the process by making some areas of assessment more rigorous and others more streamlined. The appeals process is being updated for devices that don’t receive clearance and the information required for each submission is being clarified.

But even with a fast-track option, review times for medical

Classification of dermal fillers

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nlike Botox, which is classed as a prescription-only drug, dermal fillers are classed as class III medical devices in both the EU and America.

However, FDA clearance is required for approved wrinkle filling products in the US, whereas only a CE mark is needed across Europe. While fillers have a generally good safety profile, aesthetic bodies in the UK are calling for fillers to be reclassified and to undergo stricter regulation.

Over 160 fillers are available in the UK which, according to their classification, do not need to be prescribed or administered by a doctor or medical aesthetic professional. They are simply regulated by production standards, rather than efficacy.

By contrast, the FDA has so far approved only 14 dermal fillers.

The 2010 UK deregulation bill means anyone can provide aesthetic injectable or laser treatments. The independent register Treatments You Can Trust (TYCT) was established as an alternative to statutory regulation to monitor providers.

But many agree that dermal fillers are poorly monitored. A 2011 report published in the Journal of the European Academy of Dermatology and Venereology Sally Taber: Significant showed the scope to strengthen existing medical device consedirectives quences of

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Calls for dermal fillers to be reclassified as medicines

side-effects associated with Novabel, a soft tissue filler launched by Merz Aesthetics in 2009. Four of the 10 patients in the study developed swelling and granulomatous reactions in areas treated with the filler.

After contacting the manufacturer, the authors were told there was no data available for these side-effects and they were most likely a result of “suboptimal injection technique.” The product was later removed from the market following multiple reports of side-effects.

The report concludes: “The inadequate response of manufacturer to our reporting the side-effects along with the available data on the registration process of dermal fillers confirmed that the area is not well regulated. The status of dermal fillers as class III medical devices, and the process of their approval and marketing in the EU, need to be reconsidered to avoid unnecessary and serious adverse reactions.”

Following the PIP implant scandal, BAAPS urged more government regulation to safeguard consumers and establish stronger controls in the UK. The association has called for dermal fillers to be reclassified as medicines. The

move would provide an audit trail to prescribers supplying beauticians, creating another public safety measure.

Others have called for stronger directives within the existing process. Sally Taber, spokesperson for Treatments You Can Trust, says: “TYCT wishes to strengthen the assessment, registration and manufacturing quality of medical devices ultimately leading to better patient safety and outcomes. We believe there is significant scope to strengthen the existing medical device directives and guidelines which will ultimately lead to better quality medical devices being made available.”

According to the MRHA, dermal fillers are not likely to be reclassified anytime soon. An MHRA spokesperson said: “Injectable aesthetic fillers placed on the market with a medical purpose come within the definition of a medical device and not a medicine and are therefore regulated under the terms of the Medical Devices Directive.”

Injectable filler medical devices come within one of the highest risk classifications, says MRHA, and the manufacturer must be able to provide evidence of the safety, quality and performance of their product before they can place it on the market.

“They are required to meet specified requirements which include having clinical evidence to support the claims made, a risk assessment on the device and a conformity assessment certification from a competent, notified body designated to undertake this function by a European member state's national regulatory authority,” the regulator says.

body language www.bodylanguage.net

Wigmore Medical 020 7514 5104 invasix@wigmoremedical.com

regulation Helen Twinam

devices are much higher in the US than in Europe. A 2010 report by Stanford University, FDA Impact on US Medical Technology Innovation, compared regulatory timelines between the US and Europe. A medical device, submitted for both 510(k) and CE marking, took an average 31 months from first communication to clearance with the FDA. The same product took only seven months for certification to be awarded in the EU. A bipartisan bill passed by the US Senate to help fund the FDA will aim to speed up the approval of new drugs and medical devices. On top of fees already collected by the FDA by brandname drug and medical device manufacturers, the legislation will require generic drugmakers to pay for FDA review and product approval. This new fee is estimated to raise $300m per year and would reduce approval time to 10 months.

European Medicines Agency In the European Union, the European Medicines Agency (EMA) acts as a non-regulatory agency, coordinating the evaluation and monitoring of medical products regulated by individual state bodies. Marketing authorisation issued by the EMA is valid across all EU member states and the European Economic Area.

Each country’s regulatory authority is responsible for monitoring product safety profiles.

The Medicines and Healthcare Products Regulatory Agency (MHRA) was formed in 2003 following a merge of two other agencies—the Medicines Control Agency and Medical Devices Agency—resulting in a unified regulatory body overseeing both drugs and medical devices.

The MHRA works with other regulatory bodies: the EMA, FDA, National Patient Safety Agency and the National Institute for Health and Clinical Excellence (NICE). The UK medicine licensing process is similar to that required by the FDA. The license, or marketing authorisation, requires sufficient safety testing, clinical trials and submission of data for assessment by the MHRA. However, most new types of medicine are licensed by the EMA, for general approval across all EU states.

New medicines are followed up for two years and labelled with a black triangle to show the medicine needs to be monitored carefully for unknown side-effects. Serious adverse events are reported to the MHRA which can then withdraw the product or suspend production. The black triangle is removed only

Cosmeceuticals aren’t recognised by the FDA. If they have pharmaceutical properties, they must pass through the drug approval process

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when the agency is satisfied of the drug’s safety in large numbers of patients.

Across the EU, medical devices have to conform with EC directives, shown by a CE mark on the product, which allows for free movement within the European market. In legal terms, the CE mark is not a quality mark.

But medical devices must comply with EEC directives and prove to be safe and function Medical devices in Europe are givin a medical-technical way, as en a CE mark to show the proddescribed in the manufacturer’s uct’s compliance. Use of the FDA logo on packaging is forbidden, “intended purpose”. as the agency says it would signify Manufacturers must first its endorsement of a private orverify whether a product falls ganisation, product or service into the definition of a medical device, according to Directive 93/42/EEC. They must then carry out a conformity assessment and sign an EC declaration of conformity to confirm that the product meets the requirements of the directive. This enables an enforcement authority to identify who is responsible for a product and what that person claims to have done to CE mark it. Once on the market, it is the responsibility of the country’s regulatory body to monitor.

In the UK, the MHRA licenses medicines but does not approve or control medical devices. It acts as a “competent authority”; appointed by the government to ensure medical directives are applied. But if CE-marked products arouse safety concerns and are reported to the MHRA—such as early on in the case of PIP implants (see panel)—the regulator cannot stop the product being sold in the UK and can only inform users and recipients of the potential risks.

As with the FDA, EU approval for medical devices is granted for a specific use with specific medical indications. Approval does not mean the product is safe for any use and neither approval guarantees good results—clinical outcomes are always operator-dependent.

To help ensure patient safety, industry regulation and licensing of devices must be balanced. In the US, laws differ by state.

In many areas, only qualified physicians and registered nurses are allowed to perform cosmetic laser or injectable procedures.

In others, a physician must supervise the treatment.

In the UK, the regulation of cosmetic laser or IPL operators is hotly debated within the industry and has divided opinion.

Healthcare professionals carrying out treatments for “disease, disorder or injury” using laser or IPL devices require registration with the Care Quality Commission (CQC). But those performing cosmetic laser or injectable treatments do not and are, effectively, unregulated.

In October 2010, a UK bill deregulated injectable cosmetic and laser procedures, meaning that anyone could provide such treatment. Treatments You Can Trust, which works with the DoH, CQC and Health Protection Agency, provides an alternative to statutory regulation. Those registered and assessed receive a quality assurance mark, showing they have attained a high standard of care.

Ultimately, for medical device regulation to be truly effective, each healthcare provider or clinic must always employ suitable device management practices—ensuring consistent monitoring and record-keeping, training practices and following manufacturers’ instructions. Just because a device is deemed “safe” by authorities, practitioners must not become complacent.

37

regulation Helen Twinam

PIP and CE marking Reviews into the roles of UK regulators during the Poly Implant Prosthese crisis reveal failings in communication and manufacturer inspections

I

n light of the PIP scandal, a review of clinithe CE marking process,” Mr Fatah says. cal governance and medical device regulation Mr Tim Goodacre, chairman of the profesis being undertaken by NHS medical director sional standards committee at BAPRAS, agrees Sir Bruce Keogh. A separate investigation by that routine incident reporting and review of outHealth Minister Lord Howe has looked into the come data by surgeons and providers should be the role of the DoH and MHRA and has concluded norm. “This endorses our current programme to “serious lessons must be learned” from the scandal. establish robust and rigorously used systems of data The FDA banned use of the implants across the collection by our members and indeed all plastic US in 2000 after questions were raised about their surgeons. We naturally also support fully the recmanufacture. Jean-Claude Mas, founder of the comommendation that a well designed breast implant pany, received a warning letter from the FDA deregistry be re-established, and believe that such a Jean Claude Mas: PIP was prewarned of scribing the PIP implants as “adulterated” and citing process could act as a model or template for other inspections—docu11 deviations from good manufacturing practices. higher risk implanted devices.” ments and containers But the French and, consequently, UK governmenThe EU Medical Devices directive is due to be would be made to “disappear” tal authorities were not made aware of the warning. redrafted in September and the European ComThe implants were finally banned in 2010 when mission has stated its intention to rewrite legisit was discovered that industrial grade silicone was lation. European Health and Consumer Policy being used in the manufacturing process. Lord Commissioner John Dalli says patients' health is Howe’s report concedes that regulation alone canthe priority. not prevent deliberate fraud and the MHRA fol“I have proposed to the health ministers a set lowed clinical and scientific advice. However, UK of the most urgent and important actions, which authorities should have adopted a “higher level of should be implemented under the current legislaproactive public communication”, Lord Howe says, tive framework in the course of this year. We are and the MHRA should review its communications taking on board the lessons learned from the PIP capability and improve report analysis about higher case in the upcoming revision of the Medical DeCommissioner Dalli: risk medical devices.

Strengthening legislavices legislation to be tabled before the summer. tion of market surveilThe review states that all EU regulators need to In particular, we will strengthen the legislation in lance and vigilance develop a better support network for early detecrelation to market surveillance, vigilance and function of problems and the sharing of information. tioning of notified bodies,” Mr Dalli says.

But in the face of a lack of public confidence in the The proposal includes stringent measures to asMHRA, Lord Howe has assured that the regulator sess all high risk medical devices prior to sale and will be better prepared in the future. the implementation of “implant cards” showing “This report won’t repair the distress caused to detailed information for consumers. women who have PIP implants, but it should give MEPs have adopted a non-binding resolution them and the public reassurance that we have idencalling for medical devices to be subject to the tified the lessons, that we will take all steps to act same pre-authorisation inspection rules as medion them, and that, should something like this hapcines—such as unannounced test visits by inspecLord Howe: UK aupen again, our systems for dealing with it will be tors—and compulsory breast implant registers in thorities should have stronger,” Lord Howe says. all EU member states. adopted higher level The British Association of Aesthetic Plastic A key failing recognised in the PIP case was the of proactive public communication Surgeons has proposed a six-point plan to help CE inspection process, or rather “prewarning” of inestablish tighter controls for aesthetic providers. spection visits. Local regulator TÜV Rheinland sent Measures included establishing an implant register, inspectors to the manufacturing site but company reclassifying dermal fillers as medicines and revalidation and executives were pre-informed of the visit. Mr Mas has said the mystery shopping in CE marking. Fazel Fatah, BAAPS presi- regulator announced its visits 10 days beforehand. dent, attributes much of the PIP crisis to poor post-marketing "That was the routine,” he said to French journalists. “I surveillance of medical devices. “At BAAPS we feel there needs would give the order to hide all the documents regarding the to be significantly more stringent monitoring of all medical de- non-authorised PIP gel and as far as the containers were convices, including breast implants and all cosmetic injectables, via cerned, the staff would organise themselves to make them disapcompulsory, regular reporting of adverse effects and mystery pear." PIP’s technical director Thierry Brinon told investigators: shopping, which are all part of our regulation proposals.

"As long as organisations give us systematic notice of inspection, “This is an opportunity for the Department of Health to get it any kind of malpractice can be hidden." right, and put the necessary systems and checks in place to avoid a Sir Bruce Keogh’s review into the regulation of cosmetic interrepeat fiasco. Clearly changes are also needed at European level of ventions will be presented to the Health Secretary in March 2013.

38

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The Clarisonic Opal Sonic Infusion is the second major product in the Clarisonic family and utilises the same sonic technology to gently massage Anti-Ageing Sea Serum into the area around the eye where it matters most. The Sonic micro-massage visibly infuses more serum beneath the surface than finger tapping and starts to work immediately on the appearance of fine lines.

For more information contact uksales@clarisonic.com, clarisonic.co.uk Clarisonic is a registered trademark of Pacific Bioscience Laboratories, Inc. Sonicare is a registered trademark of Philips Oral Healthcare Inc., which is not affiliated with PBL or Clarisonic. © 2011 Pacific Bioscience Laboratories, Inc.

special report Dr Masud Haq and Professor Syed Haq

Thyroid disorders T

he prevalence of primary hypothyroidism in the general population varies but is reported to be as high as 4–5% (1 in 20 adults).

Of particular interest is that the incidence of hypothyroidism in the UK appears to be rising for no apparent reason. In the UK, levothyroxine is now the third most prescribed drug after statins and aspirin.

The most common cause of primary hypothyroidism in the Western population is autoimmune thyroiditis (also known as Hashimoto’s disease). In many other parts of the world, iodine deficiency remains the commonest cause.

Other common causes include surgical removal of part or all of the thyroid, post-radioiodine therapy, and various drugs such as amiodarone, lithium, thionamide, iodine and interferon. Transient hypothyroidism may be observed in subacute (de Quervain’s) thyroiditis, which typically follows a viral infection, and in post-partum thyroiditis. In both of these conditions the majority of patients body language www.bodylanguage.net

Controversy surrounds the best methods for diagnosing thyroid disorders and there are numerous opinions on how best to manage the condition. Many patients on thyroid hormone replacement are either under- or over-replaced. Dr Masud Haq and Professor Syed Haq unravel some of these issues regain normal thyroid function.

Congenital hypothyroidism, owing to a failure in normal thyroid development (agenesis or dyshormonogenesis), affects about 1 in 4000 births and is the commonest congenital hormonal disorder.

Diagnosis There are many classical symptoms commonly associated with hypothyroidism.

These include tiredness, weight gain, dry skin, cold intolerance, hair loss, constipation, puffiness around the eyes, face and hands, hoarse voice, muscle weakness and poor memory. Although the likelihood of hypothyroidism being present increases with the number of symptoms detected, an absence of symptoms does not rule out the diagnosis. Furthermore, these symptoms are non-specific and may be observed in other conditions such as anaemia, chronic fatigue, kidney and re-

nal disease, diabetes, adrenal insufficiency and vitamin D deficiency. Therefore, the diagnosis of hypothyroidism must be made biochemically.

The only validated method of testing thyroid function is on blood or serum, which must include measurement of thyroid‐stimulating hormone (TSH) and free thyroxine (FT4). There is no evidence to support the use of urine or saliva to test for thyroid function. Laboratories that measure thyroid function in this manner need to provide analytical and clinical validation to demonstrate their efficacy.

Overt primary hypothyroidism is typically diagnosed with a serum TSH concentration above the reference range in the presence of low FT4. If the TSH is raised but FT4 is in the normal range, this is referred to as subclinical hypothyroidism. A typical reference range for TSH is 0.27–4.2 mIU/L, with most pa41

special report Dr Masud Haq and Professor Syed Haq

tients with overt hypothyroidism having a TSH above 10 mIU/L. There are many controversies surrounding TSH reference ranges. First, because the TSH in the general population is not normally distributed, it has been suggested that the upper limit of the TSH reference range should be lowered.

Second, because the TSH distribution and reference limits are influenced by age and racial origin, the use of age and racestandardised TSH reference ranges have been suggested.

Treatment Synthetic levothyroxine first became available for clinical use in the 1930s.

However, it took many years before levothyroxine became preferable to desiccated thyroid extract as the treatment of choice for hypothyroidism. In 1952, Gross and Pitts-River identified the more potent liothyronine (tri-iodothyronine).

Levothyroxine is the treatment of choice for hypothyroidism. It has a seven-day half-life, therefore, permitting a daily dosing schedule. Conventionally, hypothyroid patients are advised to take levothyroxine on an empty stomach half an hour before breakfast to aid with absorption.

The aim of treating hypothyroidism is to render the patient back to the normal or “euthyroid” state. When starting levothyroxine therapy, serum TSH levels should be measured after 6–8 weeks after initiation of, or a change in dosage. Once the patient is on a stable dose, annual monitoring of serum TSH is recommended. It is widely accepted to aim for a TSH in the lower half of the normal range, ie, typically around the 2 mIU/L mark.

However, fine-tuning of TSH inside the reference range may be needed for individual patients. Overtreatment, leading to a suppressed TSH of below 0.1 mIU/L, should be avoided, as this can be associated with adverse skeletal health and palpitations, particularly in the elderly.

Patients with continuing symptoms after appropriate levothyroxine treatment should be further investigated to diagnose and treat the underlying cause.

Combination therapy A significant number of hypothyroid patients treated with levothyroxine do not feel completely well despite having normal TSH. In these patients it is possible that serum TSH may not accurately reflect tissue thyroid hormone concentrations. Indeed, many patients on levothyroxine do not achieve a physiological FT3/FT4 ratio despite serum TSH being 42

in the normal range, suggesting conversion of thyroxine to triiodothyronine may be impaired. These observations have led some to support triiodothyronine– levothyroxine treatment combination as necessary to restore tissue levels.

A meta-analysis, however, of several randomised controlled studies has concluded that combination therapy is not more effective than levothyroxine alone.

It is quite possible that combination therapy is effective only in a subgroup of patients. This is supported by a recent study, which showed patients with a common genetic variation in the deiodinase type 2 (DIO2) gene are associated with a greater response to combination therapy.

Desiccated pig thyroid extract Armour thyroid (Forest Pharmaceuticals) contains both thyroxine and triiodothyronine extracted from the purified thyroid gland of pigs. A single grain (60mg) contains about 38mcg of thyroxine and 9mcg of liothyronine in a ratio of 4:1.

This is in comparison to 14:1 of these hormones in the normal human thyroid.

In other words, Armour thyroid extract contains much higher amounts of T3 relative to T4.

Moreover, dessicated thyroid extract contains other substances apart from T4 and T3 making these preparations not as pure as synthetic thyroid hormone. Problems with stability can give rise to fluctuations in serum thyroid hormone levels.

This has led to previous recall of tablets by the US Food and Drug Administration (FDA).

There has never been a direct headto-head comparison of Armour thyroid vs Levothyroxine in the treatment of hypothyroidism and, as a consequence, Armour thyroid and similar preparations are available only on a private prescription basis.

Subclinical hypothyroidism Sub-clinical hypothyroidism is defined as being present when the serum TSH is above the upper limit of the reference range (usually 5–10mU/L), and FT4 levels are within the normal range. Although patients do not classically have symptoms, many do.

The prevalence in the general population has been reported to be as high as 8% but appears to be even more common in the elderly. There is evidence to suggest a proportion of these patients do progress towards overt hypothyroidism, particularly those with positive thyroid peroxidase antibodies.

A recent meta-analysis of 55,000 pa-

tients from 11 studies has demonstrated that subclinical hypothyroidism is associated with an increased risk of cardiovascular events and mortality, particularly if TSH is greater than 10 mIU/L. Most experts, therefore, recommend levothyroxine in patients with subclinical hypothyroidism when TSH levels are greater than 10 mIU/L. In women with subclinical hypothyroidism who are planning to conceive or who are pregnant, levothyroxine treatment should be considered. In the asymptomatic elderly patient, TSH should be monitored at three to six monthly intervals. Only when patients become symptomatic or there is a rising trend in TSH should treatment be considered. Even then, levothyroxine should be introduced gradually with close monitoring, as many such individuals will have coexisting cardiac disease.

Dr Masud Haq is a consultant endocrinologist and Professor Syed Haq is a consultant physician at the London Preventative Medicine Centre, 10 Harley Street. Both physicians are on the editorial board of Body Language References Vanderpump MP, Tunbridge WM, French JM, et al. “The incidence of thyroid disorders in the community: a twenty-year follow-up of the Whickham Survey,” Clin Endocrinol (Oxf). 1995;43(1):55–68.

Parle JV, Franklyn JA, Cross KW, Jones SR, Sheppard MC. “Thyroxine prescription in the community: serum thyroid stimulating hormone level assays as an indicator of undertreatment or overtreatment,” Br J Gen Pract.

1993;43(368):107–109.

Andersen S, Pedersen KM, Bruun NH, Laurberg P. “Narrow individual variations in serum T(4) and T(3) in normal subjects: a clue to the understanding of subclinical thyroid disease,” J Clin Endocrinol Metab. 2002;87(3):1068–1072.

Grozinsky-Glasberg S, Fraser A, Nahshoni E, Weizman A, Leibovici L. “Thyroxinetriiodothyronine combination therapy versus thyroxine monotherapy for clinical hypothyroidism: meta-analysis of randomized controlled trials,” J Clin Endocrinol Metab. 2006;91(7):2592–2599.

Rodondi N, den Elzen WP, Bauer DC, et al. “Subclinical hypothyroidism and the risk of coronary heart disease and mortality,” JAMA. 2010; 304(12):1365–1374.

Association for Clinical Biochemistry, British Thyroid Association, British Thyroid Foundation. “UK guidelines for the use of thyroid function tests,” 2006.

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onfidence is Reliable1,2 Rewarding3 Performance4,5 BOTOX® is licensed for the treatment of moderate to severe glabellar lines Delivers long-lasting patient satisfaction, time after time2,3 Has been used for over 20 years in over 26 million treatment sessions worldwide6 Is the world’s first and most studied botulinum toxin*7

BOTOX® (botulinum toxin type A) Abbreviated Prescribing Information Presentation: Botulinum toxin type A (from clostridium botulinum), 50 or 100 or 200 Allergan Units/vial. Indications: Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar lines), in adults <65 years, when the severity of these lines has an important psychological impact for the patient. Dosage and Administration: See Summary of Product Characteristics for full information. Do not inject into blood vessels. Doses of botulinum toxin are not interchangeable between products. Not recommended for patients <18 or >65 years. Use for one patient treatment only during a single session. Reconstitute vial with 1.25ml of 0.9% preservative free sodium chloride for injection (4U/0.1ml). The recommended injection volume per muscle site is 0.1ml (4U). Five injection sites: 2 in each corrugator muscle and 1 in the procerus muscle: total dose 20U. Contraindications: Known hypersensitivity to any constituent. Infection at proposed injection site(s). Warnings/Precautions: Relevant anatomy and changes due to prior surgical procedures must be understood prior to administration. Do not exceed recommended dosages and frequency of administration. Adrenaline and other anti-anaphylactic measures should be available. Reports of side effects related to spread of toxin distant from injection site, sometimes resulting in death. Therapeutic doses may cause exaggerated muscle weakness.

Caution in patients with underlying neurological disorder and history of dysphagia and aspiration.

Patients should seek medical help if swallowing, speech or respiratory disorders arise. Clinical fluctuations may occur during repeated use. Too frequent or excessive dosing can lead to antibody formation and treatment resistance. The previously sedentary patient should resume activities gradually. Caution in the presence of inflammation at injection site(s) or when excessive weakness/ atrophy is present in target muscle. Caution when used for treatment of patients with peripheral motor neuropathic disease. Use with extreme caution and close supervision in patients with defective neuromuscular transmission (myasthenia gravis, Eaton Lambert Syndrome). Contains human serum albumin. Procedure related injury could occur. Interactions No interaction studies have been performed. No interactions of clinical significance have been reported. Theoretically, the effect may be potentiated by aminoglycoside antibiotics or other drugs that interfere with neuromuscular transmission. Effects of administering different botulinum toxin stereotypes simultaneously, or within several months of each other, is unknown and may cause exacerbation of excessive neuromuscular weakness. Pregnancy: BOTOX® should not be used during preganancy unless clearly necessary.

Lactation: use during lactation cannot be recommended. Adverse Effects: See Summary of Product Characteristics for full information on side effects. Based on controlled clinical trial data, the proportion of patients that would be expected to experience an adverse reaction after treatment is 23.5% (placebo: 19.2%). In general, reactions occur within the first few days following injection and are transient. Pain/burning/stinging, oedema and/or bruising may be associated with the

injection. Frequency By Indication: Defined as follows: Very Common (> 1/10); Common (>1/100 to <1/10); Uncommon (>1/1,000 to <1/100); Rare (>1/10,000 to <1/1,000); Very Rare (<1/10,000). Infections and infestations. Uncommon: Infection. Psychiatric disorders. Uncommon: Anxiety. Nervous system disorders. Common: Headache. Uncommon: Paresthesia, dizziness. Eye disorders. Common: Eyelid ptosis. Uncommon: Blepharitis, eye pain, visual disturbance.

Gastrointestinal disorders. Uncommon: Nausea, oral dryness. Skin and subcutaneous tissue disorders. Common: Erythema, Uncommon: Skin tightness, oedema (face, eyelid, periorbital), photosensitivity reaction, pruritus, dry skin. Musculoskeletal and connective tissue disorders.

Common: Localised muscle weakness, Uncommon: Muscle twitching. General disorders and administration site conditions. Common: Face pain, Uncommon: Flu syndrome, asthenia, fever.

The following other adverse events have been reported since the drug has been marketed: dysarthria; abdominal pain; vision blurred; pyrexia; focal facial paralysis; hypoaesthesia; malaise; myalgia; pruritus; hyperhidrosis; diarrhoea; anorexia; hypoacusis; tinnitus; radiculopathy; syncope; myasthenia gravis; erythema multiforme; dermatitis psoriasiform; vomiting and brachial plexopathy; rash; psoriasiform eruption; anaphylactic reaction (angiodema, bronchospasm); alopecia and madarosis.

Adverse reactions possibly related to spread of toxin distant from injection site have been reported very rarely (exaggerated muscle weakness, dysphagia, or aspiration pneumonia which can be fatal). NHS Price: 50 Units: £77.50, 100 Units: £138.20, 200 Units £276.40. Marketing Authorization Number: PL 00426/0074 Marketing Authorization Holder: Allergan Pharmaceuticals (Ireland) Ltd., Westport, Co. Mayo, Ireland. Legal Category: POM. Date of preparation: November 2011.

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk Adverse events should also be reported to Allergan Ltd. UK_Medinfo@allergan.com or 01628 494026.

References: 1. De Almeida A et al. Dermatologic Surgery 2007;33:S37–43. 2. Carruthers A et al. J Clin Res, 2004;7:1–20. 3. Stotland MA et al. Plast Reconstr Surg, 2007;120:1386–1393.

4. Beer KR et al. J Drugs Dermatol, 2011;10(1) :39–44. 5. Lowe et al. Am Acad Dermatol, 2006;55:975-980. 6. Allergan data on file. BOTGL/001/SEP 2011 7. Allergan Data on File VIS/006/JUL2011. *Allergan botulinum toxin type A. Global figures. Launched in 1989 in the US. UK/1010/2011 Date of Preparation November 2011

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Convenient anti-ageing kit As most of us are always pressed for time, prepackaged kits that assemble the products needed for a holistic skin treatment are very much welcomed.

The Image MD Kit protocol is a daily, ongoing skincare protocol that the manufacturer says supports skin’s natural defense mechanisms, fights free radical damage from environmental exposure and compensates nutritional imbalance of cells.

The kit contains four products to target fine lines, wrinkles and droopy skin, crow’s feet, pigmentation, sun damage, age spots, dryness, dull, tired looking skin with rough complexion and reverses the signs of cellular damage.

Reconstructive Facial Cleanser is for daily cleanser that exfoliates, gently removes make-up as well as speeds up cellular turnover for rejuvenation. It also increases the ability for active ingredients to penetrate deeper into skin for maximum benefit, says SkinGeeks.

Reconstructive Serum with a stabilised vitamin C complex combats ageing effects with high concentration of anti-oxidants and “lightens, tightens and brightens”; Reconstructive Repair Crème blends retinol, glycolic acid and oil soluble vitamin C to resurface, rejuvenate and repair ageing skin; Reconstructive Moisturizer SPF 30 uses plant-derived stem cells to protect from UV. A high concentration of anti-oxidants ergothioneine, green-tea and resveratrol reduces free radical damage, says the manufacturer. Complementing the kit are Reconstructive Retinol Booster and Reconstructive Lightening Crème.

Skin Geeks Ltd; T: 01865 338046; E: info@skingeeks.co.uk; W: skingeeks.co.uk

Treating red raised scars Red raised scars are the target of SilDerm Scar Gel, a formulation of naturally occurring silicones. The gel takes up to three months to work, but results can be seen in two weeks, after which the scar will flatten and the redness will lighten, says SilDerm.

To use, the skin should have healed.

A thin layer of the gel is applied over the scar and left to dry. SilDerm claims the scar is effective for old scars up to 20 years old. But if the scar is flat, indented or white rather than red and raised, it will have little effect, the company says.

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REVENEZ 1, a web-based app for the IPad, has been devised by a US company to fast-track prospects to a clinic’s online marketing pages.

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45

Brushstrokes

PRIORI Cellular Recovery Serum mimics the skin’s own repair enzymes to normalise and repair cells. The core of the serum is identified as DNA enzyme complex, which repairs DNA damage both in the nucleus and the mitochondria to improve skin healing and reduce wrinkles and imperfections. Cellular Recovery Serum leaves the skin with a matte finish, making it good for use as a primer while boosting the anti-ageing performance and effectiveness of any skincare regimen, Priori claims.

peer to peer

Dr Soren Demin is a biotechnology researcher who works at the Harley Street Skin Clinic

Dr Christine Coffey is an aesthetic doctor and the UK & Training Doctor for PronoKal

Geoff Bond is an evolutionary lifestyle anthropologist and author of Deadly Harvest: The Intimate Relationship Between Our Health and Our Food

Dr David Goldberg is a dermatologist and laser expert. He is also director of Skin Laser & Surgery Specialists of New York and New Jersey

Dr Matteo Tretti Clementoni is a plastic surgeon at Istituto Dermatologico Europeo in Mllan, Italy

Mr Taimur Shoaib is a consultant plastic and reconstructive surgeon based in Glasgow

Mr Lucian Ion is a consultant plastic surgeon at the Chelsea and Westminster Hospital in London

Professor Syed Haq is director of the London Preventative Medicine Centre in Harley Street. He is also an honorary consultant at the Chelsea and Westminster Hospital NHS Foundation Trust

Lasers, diets and longevity Our expert panel cover a range of topics from laser recommendations to weight loss, oxidative stress and our 60,000-year-old ancestors Q How effective are lasers for treating stretch marks?

Dr David Goldberg: Almost every device that I’ve used over the last 25 years has been applied to stretch marks. The one you use depends on what you are trying to accomplish.

With early red stretch marks, you can use a pulsed dye laser, intense pulsed light source or a other vascular technologies to lighten the redness.

Fully developed stretch marks show a loss of pigmentation and atrophy. Your job is to make that scar look better.

We’ve had reasonably good experience with many devices, whichI shall group into non-ablative fractional lasers and radiofrequency. They’re not terribly aggressive; they all create new collagen and they make thestretch marks look better, which is most important.

If a patient has, say, five treatments and you review the progress six months later, they will look better. But they will still be there, so you have to create realistic expectations. You see pictures sometimes where the stretch mark has totally gone—what I call a “home run”—but few of us get that.

If you see improvement, this doesn’t mean the pigment is coming back, which is a whole other issue. Some devices can recreate the pigment. In the end, patients will still have the stretch marks but they will look better.

Dr Matteo Tretti Clementoni: I would sugbody language www.bodylanguage.net

gest that, if you were going to buy a laser only for stretch marks, don’t buy it. If you have a laser for other indications, try it on stretch marks first. It might also suit that purpose.

Q For someone starting out in lasers, what would you recommend? Something that targets a variety of indications?

Dr Matteo Tretti Clementoni: In 1996, I started with an IPL because it treats many indications. I do not have just one day for treating vascular lesions, one for pigmented lesions, one for rejuvenation. At 8am I might have a patient for rosacea, followed by a patient for blemishes, followed by a patient for aggressive treatment. So I would suggest starting with an IPL. It is not better than other technologies, but it is multifaceted.

Dr David Goldberg: I started a decade before you, before there even was IPL. It would depend where in the world I am and what colour skin I’m treating.

If I’m treating lighter skin types and I’m starting from scratch, I would definitely start with an IPL. But if I were starting in an area with patients with darker skin, I would be more concerned about using an IPL. So there are other factors you need to consider.

Q New liposuction technologies, such as laser-assisted or radiofrequencyassisted, introduce new complications

in addition to those associated with standard liposuction. Will new users increase their complication rates with these new techniques?

Mr Taimur Shoaib: I work with Vaser, which can cause burns, as can power-assisted liposuction. The machine gets hot, and so do the probes. So to avoid this, you have to cool the skin and use cold swabs for both Vaser and power-assisted liposuction. We have to protect the skin.

Mr Lucian Ion: Radiofrequency-assisted liposuction is a technique where you do not have non-dominant hand control.

Training needs to start with suction-assisted liposuction and evolve to energyassisted techniques. For me, prior experience with Vaser liposuction has helped.

But there is a perception that energy-assisted techniques are easier to learn and master, which is not the case.

There is a temptation to use high temperatures to achieve tightening, particularly in older patients. This is often overlooked in discussions. Fat becomes more fragile as we age. There is a different type of tissue texture that allows fat to be extracted easily but the thermal injury has higher impact.

Q What is the real advantage of using these machines over traditional liposuction?

Mr Taimur Shoaib: There is new research coming out in the plastic surgery journals which suggests that VASER is associated 47

peer to peer

Hair loss can occur with any low calorie diet, especially those decreasing a patient’s lipid intake—hair follicles need oil for replenishment and growth. But once the fat intake is increased, the hair loss stops

with less bruising and more skin tightening. Many VASER surgeons thought this to be the case, but we now have some quantification of this.

Q What

are your thoughts on skin tightening?

Mr Lucian Ion: When we see an effect of reduced gliding, we typically call it “tightening”, but this can be related to the skin’s support, to the length of the deep collagen fibres, and to their strength. This is the mechanism behind heavy folds of skin, for example, with people who have lost weight, because the tissue adherence zones are not even.

Surgery frees up points of support and creates zones, aiming for a more even distribution. With Vaser or suction-assisted lipo, I have never seen a similar lifting effect of the umbilicus from liposuction in the upper abdomen. But with radiofrequency-assisted liposuction, I have.

If you look at after images of these patients, they do not have the hooding effect over the umbilicus, because there is something holding that skin up. I do not think it is because the skin of the abdomen has been shrunk, but because it adheres better to the fascia.

Q As shown in a study carried out on people undergoing the PronoKal diet for weight loss, one of the side effects is hair loss. Why is that?

Dr Christine Coffey: This can occur with any low calorie diet, especially if you’re decreasing a patient’s lipid intake. We decrease fat intake to 10g of lipids a day in the form of a tablespoon of olive oil daily with meals. Hair follicles need oil for their replenishment and growth so, as a temporary side effect, some patients do notice some hair loss while on the programme.

Once we start increasing fat intake again, the hair loss stops. It’s not that 48

common—I see only around 1–2 cases in every 30 patients. If it does happen, we can increase the omega-3 and omega-6 in their diet and provide topical treatments like minoxidil. So this side effect is very manageable and only temporary.

The most important thing is making the patient aware of this at the start of the program.

Q The

commonest causes of hair loss—as long as the thyroid function isn’t affected—are deficiencies in selenium, folate, vitamin D and iron. Did you look at any of those parameters in this study?

Dr Christine Coffey: Yes, if any patient complains of hair loss, we rule out anaemia and test for vitamin D while increasing their Omega 3 and 6 intake and adding in a topical treatment. None of the patients in the study was anaemic.

Q Do you follow patients to see how long-lasting the weight loss is? Do they have to be committed to the diet regime for life?

Dr Christine Coffey: We follow patients for up to two years after they have completed the program. We’re currently doing an audit to see what percentage of patients keep the weight off after the program has been completed and for how long.

Every three months, PronoKal gets in touch with the patients and doctors can maintain a relationship with them and follow their patients up too. Our main focus is on long-lasting dietary reeducation—ideally we want the patients to go through the programme once, undergo re-education and keep the weight off long-term.

Q Low-calorie diets are notoriously bad for keeping the weight off longterm and, as far as I’m aware, none has

shown to prove that they can. A balanced calorie diet, I believe, is the only one that has shown solidity in studies.

Dr Christine Coffey: The PronoKal regime starts as a low-calorie diet in the first active phase—a protein diet with ketosis.

Following that, with re-education, we subsequently bring in foods with increasing calories and increasing amounts of carbohydrates.

In stages three to seven, after breaking ketosis, we slowly introduce low glycaemic index foods and work up to patients exiting the program with a personalised balanced diet plan, structured individually for each patient and their respective lifestyles.

These patients will be followed up for two years and they can approach PronoKal for advice and support after these two years are up.

Q There are studies relating to vitamin D deficiency and weight loss.

Those who are dieting further reduce their levels of vitamin D, so how do you account for that?

Dr Christine Coffey: We haven’t been routinely testing patients for low vitamin D levels but we are considering introducing it. We do a full blood count, liver function tests, renal function, full lipid profile and, where necessary, a thyroid function test, uric acid levels and blood glucose levels.

Patients undergo a rigorous medical screen before deciding whether they are suitable for the PronoKal program or not.

Dr Syed Haq: The pandemic in the Middle East and the high levels of diabetes are due to, in part, the low vitamin D levels and it’s important to assay that. I heard a lecture from Professor Michael Horlick about vitamin D that highlighted routine testing can save patients from having inflammatory-based chronic disease processes.

Q Dr Demin, what have you noticed from the oxidative stress test? And if someone were to have the test, would they also undergo testing such as vitamin D? Dr Soren Demin: If they choose a full blood test, that’s up to them and the doctors at the clinic. The oxidative stress test just looks at ageing and is a separate test that we add on. It provides a result within eight seconds.

In most London-based patients who come to the clinic and have the oxidative stress test, the results are usually high.

We’ve noticed that levels are reduced in patients in other parts of the country, body language www.bodylanguage.net

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Levels of oxidative stress are usually high in city-based patients. Those in rural areas such as Devon, have reduced levels, attributing to pollution and lifestyle differences between city and country life

such as rural areas like Devon. This may be down to pollution and lifestyle differences between city and country life.

Most people have reasonably high levels of oxidative stress, or accelerated ageing, in their bodies which are generally due to nutrition and diet. Some have very low levels; one particular group is the “Fulham Mums” population subset—they eat well, they eat organic food, they excercise and do yoga. The only time they get stressed is when they drop the children off at school. They are a pretty healthy group.

If those with high levels start following a balanced diet and supplements, they do tend to notice the levels start to drop.

But there are obviously other elements such as lifestyle improvement and sources of stress that need to be managed.

Q You’re

seeing changes in reactive oxygen species in oxidative stress. So what are your biological endpoints? Do you have dynamic methods of assessment in place?

Dr Soren Demin: Most of our biological endpoints are taken from animal models, predominantly mice. We’re looking at death, recovery rates and inducing trauma. Our models are good to follow a process, which is perhaps different for different animals, but we’re looking at the endpoints within the process, which is key.

In humans, we’re looking at gene models. We’re looking at oxidative stress over a period within populations. One of our teams is looking at the p66shc gene and telomere shortening and lengthening.

Q Do you agree that the only dietary regimen that has evidence to support body language www.bodylanguage.net

increasing longevity is calorie restriction?

Dr Soren Demin: I agree that calorie restriction has shown very good evidence for longevity. But what we’re trying to show are the fundamentals behind calorie restriction.

Q What is the role of reactive oxygen species and caspase inhibition in oxidative stress and ageing?

Dr Syed Haq: Caspase inhibition affects mitochondrial potential through the release of bcl-xL. That is how caspase activation or inactivation can affect ageing.

If you’re talking about the apoptosis signal kinase and that inactivation of MAP kinase is associated with oxidative stress, that’s not the case. C-jun terminal kinase and p38 MAP kinase are activated in the presence of reactive oxygen species like hydrogen peroxide.

Q Mr Bond, you say that all living humans descend from one group of people living 60,000 years ago?

Geoff Bond: Yes, and this was a bombshell when the first studies came out in the late 80s. It was discovered through DNA analysis, which was a completely unexpected, left-field result.

We had no idea we were going to find that we’re all so genetically related, and that we could track everybody on the planet back through the generations to a small group of 10,000 people some 3,000 generations ago in the savannas of East Africa.

Q So other than skin colour, we have the capacity to look just like them?

Geoff Bond: If you were to dress them up and give them a clean shave, yes, they’d

look just like us. We don’t know exactly what they looked like but we think they’d look a little like san bushmen.

They would be copper-coloured, perhaps with peppercorn hair and a more gracile bone structure. As these people spread out over the world, they moved into different environments, which affected the way they looked and lived.

We’re all still basically the same tropical creature—we’ve changed on the outside but we’re still the same 60,000 year old model underneath.

Q Lactose

intolerance is a genetic change that has evolved. Can we track how far back this happened and the reasons, such as farming and introduction of cow’s milk?

Geoff Bond: The only evidence we’ve seen is that peoples of Germanic, or northwest European origin, and perhaps one or two others, might have developed the ability to continue secreting lactase into adulthood. But the evidence seems to show that if you stop consuming milk at any point, the lactase secretion stops and it’s hard to restart it.

Dr Syed Haq: One of the things I’ve noticed is the high preponderance of patients suffering from gluten intolerance.

The way we process our foods has a much faster release of starch in the food that we’re not capable of metabolising and assimilating. It is effectively toxic to us, much like lactase—adaptive change.

We’re reaching pandemic levels with people who are undiagnosed with chronic fatigue, and this has really become apparent in the last 15–20 years. So diet has a major part to play, and the take-home message should be that we need to follow a balanced diet, however we introduce it.

51

essay Dr Stephen Bassett

Craftsmanship and credibility Aesthetic medicine is distinguished by the direct communication between patient and practitioner and the pleasure both experience in receiving and delivering a good result.

Dr Stephen Bassett elaborates on why medical practitioners should revel in this relative simplicity

I

have the pleasure or misfortune—depending on whether I travel first or standard class—of involvement in medical interests that span the public-private and medical cosmetic rainbow: running a cosmetic clinic, medical appraisal, regulatory law, fitness to practice hearings, teaching and training law and medicine and a front-row seat in national medical politics.

I have experienced the pain in the last six years of observing the near collapse of the traditional NHS, which those of us with two decades or more of experience remember, and the excitement of watching cosmetic medicine survive and thrive in the face of arraigned political and regulatory enemies over precisely the same time-scale.

Nobody, save a few extremists, attacks the ideals of the NHS— in public at least. All but a few enthusiasts praise the ideology of cosmetic medicine. Yet the latter explodes; the former implodes.

Catching up I spent a staggeringly unrewarding, frustrating hour this morning, during my weekly literature review and journal roundup session, catching up on a few months’ backlog of papers, anxiously preparing for my own appraisal. One pile included “The need for Evidence-Based Aesthetic Dermatology Practice”, C L Goh, J Cutan Aesthetic Surg 2009, pp 65–71.

I disagreed with the article, which pleaded for the introduction of more meta-analyses and randomised controlled studies into aesthetic practice, to replicate the intellectual credibility of cardiology, for example.

Conversely, I spent a staggeringly rewarding 10 minutes reviewing a woman, Sandra, in her 60s, whom I have treated over the last six months. She had come to see me on the recommendation of a friend who had been delighted with the results of her own combined mid-face revolumisation and toxin therapy.

Sandra presented with a typical combination of features, a deficit in each of what I and others have identified as the three dimensions of the ageing face. A loss of volume or turgor, a loss of resistance to muscle tension and a loss of texture. Individually it is unproblematic to identify, isolate and analyse each.

I had treated her with a combination regime of mid-face revolumisation with Radiesse and Belotero Intense, neurotoxin glabellar and peri-orbital myo-relaxation, and finally three sessions of sublative rejuvenation with eMatrix, addressing the deficits in each of the three dimensions of ageing and beauty.

52

I’ll gloss over the enormous technical simplifications implied in the last paragraph. That my professional colleagues connect with me despite simplification and summary is crucial to my argument, so I’ll leave it hanging for now.

I could provide some impressive comparative pre-treatment and post-treatment images here, but I’ll cite some more powerful evidence. Sandra tearfully reported how she could now face her husband and friends cheerfully and confidently for the first time in a decade, and more tearfully and more powerfully, how she could face her own reflection in the unforgiving morning bathroom mirror.

That, to me, is a form of evidence we ignore at our peril.

Granted, it is hyper-subjective, prone to biases and distortions, manipulation and mendacity on a grand scale, but nevertheless, if dealt with appropriately, is still the evidence we seek—indeed, crave most. In this sort of evidence we find and ground our specialty—evidence of craftsmanship, creativity and credibility.

Sandra holds the key to opening this evidential treasure chest. She is not rich, she is not chic, she is not cosmopolitan, but she knows what she wants and she knows when she’s got it.

And there’s the distinction between her and the much questioned, polled and analysed NHS patients, whose questionnaire results I see fed into colleagues’ PSQ and MSF. Sandra’s satisfaction is a direct result of her relationship with me, and the skill I have demonstrated in that relationship in delivering what I promised her—to help her look better, an admirable goal. We have a skill valued by our patients, a craft, and it does not require external validation, valuation or accreditation to make it a valid skill.

The lady doth protest too much? No. There are great political body language www.bodylanguage.net

essay Dr Stephen Bassett

and regulatory forces aligned against us, and these forces originate from the same mind-numbing middle-management that has eroded and corroded clinician confidence in the NHS. In the same pile of research and commentary that stimulated this essay, I read with amusement in this week’s BMJ how doctors, by ditching the entirety of the management superstructure, can work together as effectively as some of us remember nostalgically, to deliver what managers describe as “joined-up care”.

Some of these background ideas have been floating around since I read simultaneously Matthew Crawford’s The Case for Working With Your Hands and Ken Robinson’s Out of Our Minds. Both these works are fabulously written and present a defence of manual skills in the face of managerialism and regulatory creep—and regulatory creeps.

If you’ve been involved in or just watching, you should realise by now that what we are witnessing in mainstream NHS medicine is an attack on the credibility of doctors as skilled workers, or at least, professionally skilled workers.

I’m no Marxist, but as even right-wing thinkers such as Francis Wheen acknowledge, old Karl made some good points based on some good insights. He foresaw the commoditisation of work. That is, if it is possible to break a task down into smaller and smaller pieces, these can be provided by an increasingly mechanised and/or less-skilled workforce.

In mainstream medicine, it may be that many of the tasks, roles and jobs that have been increasingly chunked in this postFordist way cannot be so reduced without the introduction of costly escape routes and accounting fudges, but nevertheless, the commodifying paradigm rules.

Where there is commoditisation, there is cost-cutting, and the replacement of one professional by a cheaper alternative. We have yet to see massive replacement of any aspect of the care workforce by machines, but it is now commonplace to see one professional replaced by an ostensibly cheaper alternative; doctors by nurses, nurses by health care assistants, and so on down a hierarchy of skill and cost.

I emphasise ostensibly because hidden costs are magicked away in deceptive audits and reports. In an area of practice I know well, OOH care, the hidden costs of non-medical decision-making can outweigh the entire stated operational costs. Yet we are immune to much of this in aesthetic and cosmetic practice.

Neurotoxins and dermal fillers, in medical hands, are safe treatments. We, as doctors and nurses, do not have to defend the position of non-medical practitioners, and in my view, should not do so, as their failures and excesses distort any safety analysis of our own professional practice.

While there must be ethical underpinnings and a safety structure under which to operate, there does not need to be much more. Certainly not a whole lot of guidelines and protocols simply to create the impression of being evidence-based where no such evidence is needed. We must draw the distinction between guidelines that establish basic safety parameters and prescriptive guidelines that attempt to capture and pin down tacit trade knowledge.

We do not need to have the attachment that cardiology has to evidence-based medicine to be a credible craft. There are several reasons we are better off without such an approach.

First, much of EBM, when applied to mainstream—especially NHS mainstream medicine—is a cloak for cost containment, or full-on rationing. It should be obvious that, in the private sector, there is no need for this. We must discuss costs with probity, body language www.bodylanguage.net

but other than that, are free to reach any legal bargain with our patients.

Second, we don’t usually need evidence, beyond that which we can derive from our own observations, of whether a treatment works, because our concept of what works will be critically informed by our patients’ experiences. If it doesn’t deliver on its claims, our patients will soon tell us. A vibrant local economy, where patients communicate with each other on the relative merits of local practitioners, their treatments and techniques is the best forum in which to debate effectiveness. It probably serves as the best forum for a lot of regulatory talk, too. There may be some small role for comparative studies of treatments, but one would have to lack any scepticism to think that the sponsoring companies did not have an interest in the publication of such work.

Third, in general, cosmetic professionals are not seeking tenure in institutions, so the “publish or die” imperative does not apply. Much research, such as it is, is published at the behest of industry, for industry’s purposes, and the often hidden benefits to those involved—celebrity, travel, equipment—are sufficiently well-known to insiders to induce the requisite scepticism.

Fourth, we are not usually dealing with matters of life and death, which is not to trivialise their importance. A negative view of one’s appearance can induce a slow death, true, but catastrophes are rare on the couch.

Finally, close readers of EBM as applied to, say, cardiology, will note that guidelines can change. Aspirin appears to alternate between panacea and poison as each year turns.

What material of worth there is in the literature establishes proof of concept and broad safety parameters. Beyond that, we are left with the forum, in its ancient sense of the combined marketplace and courtroom for ideas, and individual reflective practice; and this last is the essence of a skill, a trade and a craft.

It is in such trade-based, craft-focused reflection on what works, what is safe, what sells, that there is the scope for creativity.

Job satisfaction The pleasure of aesthetic or cosmetic medicine is surely in the face-to-face interaction with our patients, the total absorption in manual skilled work, the knack, know-how—not know why or know what—to be a master craftsman, a “master of your own stuff” as Crawford puts it.

It is a privilege to be able to precisely escape the prison of guidelines, protocols and algorithms that have been designed with goals in mind, but clearly not the delivery of a satisfying relationship between clinician and patient. To be performing a skill where you receive direct feedback in space and time, and to receive that ultimate feedback—the report from your patient who can look in the mirror for the first time in a decade and experience joy—should be immensely satisfying.

Can we look in the mirror of our own professional practice and connect with that joy?

Dr Stephen D Bassett is a freelance GP, ADR lawyer, deputy chairman, GPC sessional subcommittee, BMA and is on the editorial board of Body Language

An ethical and safety structure must be in place under which to operate.

But we do not need many guidelines and protocols simply to create the impression of being evidence-based 53

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research Andy Pickett

Dispelling a few myths Botulinum toxins’ versatility continues to march on. Andy Pickett discusses some of the advances toxins have made in academic and clinical study while addressing popular misconceptions

B

otulinum toxin (BoNT) is a real battle ground. Three major companies, Allergan Inc, Ipsen/ Galderma and Merz, are vying for the aesthetic market. In an age when customer-patients demand the highest quality results with a minimum of downtime and financial outlay, their expectations must be assessed in the real world of everyday treatments, not just in the clinical trials used for registration of the products.

To this end, a recent survey (the ANGEL study) carried out in four European countries (UK, France, Germany and Italy) asked 551 patients how they felt about their recent BoNT treatment of Azzalure.

Simple, direct questions were used. Initial data from this survey were presented at Imcas Paris in January and have now been reported (Pickett A. “Issues in aesthetic uses of botulinum toxins. Prime; 2012:88-91).

Other surveys of patient satisfaction are available (de Boulle K, Fagien S, Sommer B, Glogau R. “Treating glabellar lines with botulinum toxin type A-hemagglutinin complex: a review of the science, the clinical data, and patient satisfaction,” Clin Interv Aging 2010;5:101-118; Carruthers J, Carruthers A, Monheit GD, Davis PG. “Multicenter, randomized, parallel-group study of onabotulinumtoxinA and hyaluronic acid dermal fillers (24-mg/ml smooth, cohesive gel) alone and in combination for lower facial rejuvenation: satisfaction and patient-reported outcomes,” Dermatol Surg Dec 2010;36 Suppl 4:2135-2145; de Boulle K. “Patient satisfaction with different botulinum toxin type A formulations in the treatment of moderate to severe upper facial rhytids,” J Cosmet Laser Ther 2008;10(2):8792) and data occasionally appear in clinical study reports. These dedicated, direct patient assessments are key and vital for the future. We expect to see many more!

But there are still statements made and commentaries given about the BoNT products used aesthetically that are based on no science or clinical evidence: they are simply incorrect. Generally, these “facts” have been used as marketing tools to persuade clinicians of the benefits of some products and the issues related to others. Even worse, these “facts” are still published today as though they were clear science and clinical evidence. Yet they are not.

The problem even extends to data tables

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of product characteristics often included in publications. These tables attempt to provide the reader with important characteristics on the BoNT products to demonstrate both their similarities and their differences.

Regrettably, many of the data are irrelevant to clinical practice and, at worst, are simply wrong! (Pickett A. “Evaluating botulinum toxin products for clinical use requires accurate, complete, and unbiased data,” Clin Ophthalmol 2011;5:1287-1290.)

Clinicians must always refer to the product information included with the products to ensure they have correct information.

An important example, the incorrect speculation about diffusion differences of the products continues to be used to differentiate them. Various product properties are stated to support these claims and biased publications given out in support, but in all cases these have been shown to be incorrect (Pickett A. “Botulinum toxin as a clinical product—manufacture and pharmacology,” in Foster K, ed Botulinum neurotoxin— molecular understanding and its application: Spinger Science; 2012 in press; Pickett A. “Dysport: pharmacological properties and factors that influence toxin action,” Toxicon. Oct 2009;54(5):683-689).

Modern data have provided us with explanations that there is no such thing as the ”toxin complex effect” on diffusion. The different products are already free neurotoxins in the vial before injection (Eisele K-H, Fink K, Vey M, Taylor HV. Studies on the dissociation of botulinum neurotoxin type A complexes. Toxicon. 2011;57(4):555-565).

Clinicians are injecting free BoNT neurotoxin, regardless of which product they use.

There are no product differences in respect of diffusion.

The dose of BoNT is the most important factor affecting results, closely followed by

knowledge of anatomy and the positions of the actual targets of BoNT, the neuromuscular junctions. Effects due to the volume of injection cannot be supported; yet, as various studies show, volume of injection both does and also does not influence clinical results (Carruthers A, Carruthers J, Cohen J. “Dilution volume of botulinum toxin type A for the treatment of glabellar rhytides: does it matter?” Dermatol Surg 2007;33 (Special Issue 1): S97-104; Abbasi NR, Durfee MA, Petrell K, Dover JS, Arndt KA. “A small study of the relationship between abobotulinum toxin A concentration and forehead wrinkle reduction,” Arch Dermatol Jan 2012;148(1):119-121).

Perhaps the most important study to examine diffusion of BoNT products and the effect of actual dose is that from Doris Hexsel and colleagues in Brazil (Hexsel D, Brum C, do Prado DZ, et al. “Field effect of two commercial preparations of botulinum toxin type A: A prospective, double-blind, randomized clinical trial,” J Am Acad Dermatol Oct 29 2011). This is a study of the anhydrotic effects of BoNT on the forehead, also previously shown to be related to coincidental areas of muscle weakness, if anything underestimating the muscle relaxation achieved (Hexsel D, Dal’ Forno T, Hexsel C, Do Prado DZ, Lima MM. “A randomized pilot study comparing the action halos of two commercial preparations of botulinum toxin type A,” Dermatol Surg Jan 2008;34(1):5259). First reported in 2009 at the main American Academy of Dermatology meeting that year, the study is characterised by careful attention to clinical details such as standardised depth and angle of injection and a clearly defined technique to demonstrate the areas of anhidrosis on the forehead. Remarkably, from the study data, the authors demonstrated that certain techniques to measure

Table 1 Comparison of BoNT products in forehead model of anhidrosis DOSE RATIO DYSPORT:BOTOX

MEASUREMENT TECHNIQUE

DIFFERENCES BETWEEN PRODUCT EFFECTS AT 28 OR 112 DAYS

2.5:1 or 2:1

ECMAP (electrical muscle activity)

Not significant

WSS Winkle Severity Scale score (photographs)

Not significant

2.5:1

Action halo (diameter and area)

Significant (p<0.001 or <0.003)

2:1

Action halo (diameter and area)

Not significant

(Based on Hexel et al, 2011)

55

research Andy Pickett

Table 2 Volume of injection for the three main aesthetic BoNTs. For treatment of glabellar lines, as reported in summary of product characteristics PRODUCT

INJECTION VOLUME PER POINT (ML)

INJECTION VOLUME PER POINT (ML)

Azzalure

0.05

0.25

Vistabel

0.1

0.5

Bocouture

0.1

0.5

Table 3 Potential effect of reduced volume of BoNT injection on pain experienced 0.03 ml

0.06 ml

1.79*

2.31*

*Pain score from Visual Analogue Scale assessed by patient (higher is more pain). Table based on Kranz et al, 2006

effect were sensitive enough to demonstrate clear efficacy differences; whereas others were not (see table 1). These results showed, for the first time, that all differences between the products previously labelled as “diffusion differences” were entirely dose effects—the greater the dose differences, the greater the effect differences observed.

The results showed why no fixed dose conversion ratio between the products can be specified. This depends on the techniques that measure the effects and all the associated clinical techniques applied. Only limited guidance for converting from one product dose to a second product can be provided.

When factors such as facial muscle anatomy, knowledge of the BoNT target positions, the mode of action of the BoNT, and the detailed clinical trial data are available, then we have established the evidence-based sites of injection for the aesthetic correction of a given area of the face. These have been summarised in, for example, consensus publications and data reviews (Kane M, Donofrio L, Ascher B, et al. “Expanding the use of neurotoxins in facial aesthetics: a consensus panel’s assessment and recommendations,” J Drugs Dermatol. Jan 2010;9(Suppl 1):s7-22; Klein AW, Carruthers A, Fagien S, Lowe NJ. “Comparisons among botulinum toxins: an evidence-based review,” Plast Reconstr Surg 2008;121(6):413e-422e; Rzany B, Ascher B, Monheit G. “Treatment of glabellar lines with botulinum toxin type A (Speywood Unit): a clinical overview,” J Eur Acad Dermatol Venereol 2010;24 Suppl 1:1-14).

Fom these summaries, comparisons may be made of certain product attributes that are clinically interesting. For example, the volume of injection to achieve the same results for the treatment of glabellar lines in adults differs between the products, with Azzalure having one-half the volume of injection when compared with the other products (see table 2).

Does this make a real difference? There is evidence to suggest that a decreased volume of injection does result in decreased pain for the patient (see table 3, based on Kranz G, Sycha T, Voller B, Gleiss A, Schnider P, Auff E. "Pain sensation during intradermal 56

injections of three different botulinum toxin preparations in different doses and dilutions," Dermatol Surg Jul 2006;32(7):886890). Only 10 patients were included in that study, making the results insufficient statistically, but an indication is there, hopefully to be expanded on in new studies.

There are few reports on patients who have developed neutralising antibodies to BoNT after aesthetic treatments, only six in total for all products worldwide and for all the years of product use. The likelihood that patients develop such antibodies is probably one in a million or fewer. But patients do stop responding to BoNT treatments. Why? No review of possible causes for absence of response is yet available; hopefully this will change in the near future. But one thing is certain about BoNT: the molecule does far more than just block the transmission of the acetylcholine signal from the nerve to the muscle, giving muscle relaxation. Many properties are known to exist even though detailed BoNT science is limited (Popoff MR, Poulain B. “Bacterial Toxins and the Nervous System: Neurotoxins and Multipotential Toxins Interacting with Neuronal Cells,” Toxins. 2010;2(4):683-737.

Take, for example, the potential use of BoNT to treat depression. This was first indicated in 2006 by two doctors in the USA with a small 10-patient case series (Finzi E, Wasserman E. “Treatment of depression with botulinum toxin A: a case series, Dermatol Surg 2006;32(5):645-649) but interest has grown to the point of a cost-effectiveness review that demonstrated the long-term benefit of BoNT treatment (Beer K. “Cost-effectiveness of botulinum toxins for the treatment of depression: pre-

liminary observations,” J Drugs Dermatol 2010;9(1):27-30).

A much larger study with careful patient assessment has shown that a single treatment of glabellar lines with BoNT can produce significant and sustained benefit for depressed patients (Wollmer MA, de Boer C, Kalak N, et al. “Facing depression with botulinum toxin: a randomized controlled trial,” Journal of Psychiatric Research May 2012;46(5):574-581). BoNT, through control of facial expression, seems to have the ability to control patient mood. But is there a direct effect on, for example, hormone or regulatory peptide secretion as well?

New directions, new trends In 2012 alone, new potential uses of BoNT have been identified for aesthetics (see table 4). But these early exploratory studies do require further substantial evidence-based clinical trials to gain the necessary information on efficacy and safety.

Useful indicator studies covering BoNT in routine clinical practice are appearing, demonstrating the benefits to the clinicians of these products. Economic studies are available for aesthetic uses, comparing the products in real financial terms (Jandhyala R. “Effectiveness of type A botulinum toxins for aesthetic indications and their relative economic impact,” Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS. Jun 2012;65(6):720-731). The reader should treat these studies with care, as assumptions are made, especially about product price.

Through good science and a clearer understanding of how BoNT works, we are able to dismiss most of the myths that have been used to try to differentiate the BoNT products. The key myth, diffusion, is not due to the product being used but to the dose—perhaps even the volume—of injection. New clinical effects are appearing, but many more trials are needed to establish these as real and substantive for patients.

Andy Pickett is director and founder of Toxin Science Ltd and adjunct professor Botulinum Research Center UMASS, Dartmouth, USA. Andy is also head of development for Q-Med, a Galderma division. The opinions and comments expressed are those of the author and Toxin Science Ltd only

Table 4 Potential new applications of BoNT in aesthetics (in 2012 only) APPLICATION TESTED

SPECIES STUDIED

REFERENCE

Fat graft survival improvement

Rat

Baek et al

Intralesional psoriasis

Human

Wang & Tsai

Hypertrophic scars

Rabbit

Xiao et a

Vitamin B supplements [no effect]

Rat

Tatlidede et al

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surgery Dennis Hurwitz

L brachioplasty

with lipo

Good candidates for L brachioplasty with liposuction are healthy and concerned about excess skin and fat of the entire upper arms and are prepared to accept a long scar running along the inner arm, writes Dr Dennis Hurwitz

A

comprehensive, reliable, and effective approach to • rapid and secure closure with #1 PDO quill barbed suture. brachioplasty with low complications in the massive This article builds on those communications with an emweight loss patient evolved in 2002. The L Brachio- phasis placed on the role of liposuction in the L Brachioplasty plasty and a retrospective review of the first 24 pa- as presented in an interactive video format at the 2012 meeting tients was published in 2006. (Hurwitz DJ, Holland SW. “The of the American Society for Aesthetic Plastic Surgery. About six L Brachioplasty: An innovative approach to correct excess tissue years ago, we made a fundamental technical improvement in the of the upper arm, axilla and lateral chest,” Plast Reconstr Surg L Brachioplasty with radical liposuction under the planned area 117:2,403-411, 2006.) of medial arm tissue excision.

The “L” of this arm reduction operation refers to the shape Following removal of as much subcutaneous fat as possible, of the skin and fat excision with the long segment being a hemi- only the excess skin is excised and the area is closed over a preellipse extending from the elbow to the axilla and the short seg- served latticework of neurovasculature and connective tissue. ment forming a right angle ellipse to the arm from the axilla to Concomitant cosmetic liposuction was performed wherever inthe upper lateral chest. dicated prior to wound closure to achieve optimal arm size and Technical clarifications and refinements prompted a publi- contour. As it is grand reduction surgery on a relatively small cation update with cylindrical strucan accompanying ture, brachioplasty video. (Hurwitz DJ, has little tolerance Keith J, L-Brachiofor technical error. plasty: “An AdaptFurthermore, this able Technique for type of comprehenModerate to Severe sive liposuction deExcess Skin and mands precise and Fat of the Arms artistic planning, for Featured Oprapid execution with erative Techniques,” a little trauma as Aesth Surg Journ, possible, secure suJuly–August 2010, ture incision closure 620-629.) These imand meticulous afprovements were tercare. Otherwise, • artistic and geothese large arms are metrically conat increased risk for firmed preoperative wound separation, markings; skin necrosis, and • excision site liponerve injury, comSix marks with a line drawn between make up the L brachioplasty (see diagram). Mark 1 is suction; promised bloodplaced at the deltopectoral groove. Mark 2 is placed along the midpoint of the arm near the • secure suture ad- bicipital groove. Mark 3 lies at the medial epicondyle. Then a line is drawn rising from point flow to the hand, vancement of the 3 to point 1. Point 4 estimates the width of resection at the midpoint of the arm to point 2 prolonged oedema, pinching the tissues. With the arm raised, a line is drawn from point 3 to point 4. Point 5 proximal posterior by lymphoceles and reis the end point of the posterior incision, which can be pulled to point. From Point 5 a line is triangular flap to drawn that curves superior to the posterior fold and then descends vertically to point 6 near sidual deformity.

Deltopectoral fascia, the 4th rib. The final line starts from point 1 and is drawn posterior to the lateral border of Whether due to the pectoralis muscle and ends at point 6 and weight loss or ag58

body language www.bodylanguage.net

surgery Dennis Hurwitz

ing, good candidates for L brachioplasty with liposuction are healthy and concerned about excess skin and fat of the entire upper arms. Lesser deformity may be treated with a more limited operation. They accept a scar along the inner and posterior arm, through the axilla and into the upper lateral chest. They accept the general risks of this operation as just written. Excess fat alone usually is treated with just liposuction.

Precise preoperative markings are initially made freehand and then confirmed with linear measurements with the patient sitting, the arms abducted, and elbows flexed 90deg. In the arm, the goal is to remove the excess skin with its underlying fat along the medial and inferior aspect of the arm, and excess fat elsewhere, so there is a properly shaped and sized arm, leaving a curvilinear scar starting from the medial epicondyle that dips posteriorly to the mid-point of the arm and then gently rises to the axilla.

The hanging and inferiorly attached arm to the chest is raised.

The axilla is reduced in area and depth. The lateral chest, posterior to the breast as far down at the lateral breast roll is reduced.

Six marks with a line drawn between make up the L brachioplasty (see diagram). Mark 1 is placed at the deltopectoral groove. Mark 2 is placed along the midpoint of the arm near the bicipital groove. Mark 3 lies at the medial epicondyle. Then a line is drawn rising from point 3 to point 1.

The estimated width of resection at the midpoint of the arm is estimated by pinching the tissues at point 3 to the posterior margin of the arm, which is marked point 4. With the arm raised, a curving line is drawn from point 3 to point 4. Further pinching of the tissues confirms the width of resection. Point 5 is the end point of the posterior incision, which can be pulled to point 1 to reduce the axilla and elevate the posterior fold.

From Point 5 a line is drawn that curves superior to the posterior fold and, on reaching the lateral chest, descends vertically to curve slightly medially about the fourth rib to point 6. The final line starts from point 1 as a perpendicular from line 1 to 3.

It is drawn posterior to the lateral border of the pectoralis muscle and ends at point 6.

To preserve neurovasculature, especially the lymphatics, complete removal of the excision site fat is anticipated. Quantitative markings, indicated by +, ++ or +++ are made as needed in the encircled areas for cosmetic removal of fat by liposuction.

Operative technique The arm positioning and operative technique is the same whether the L brachioplasty is an isolated procedure or part of an upper body lift and breast reshaping. As an isolated procedure, the short arm of the brachioplasty tapers to point 6.

If the lateral chest excision extends to the inframammary fold, the lines continue parallel with the IMF. That portion of the resection is adjusted to the demands of the spiral flap reshaping of the breast or â&#x20AC;&#x153;boomerang correction of gynaecomastiaâ&#x20AC;?. If possible, the intravenous access is other than the arms, because the IV tubing is cumbersome and some of the infusion will extravasate into the traumatised arm.

With the arm suspended by an assistant holding the hand,

The first patient (right) is 53 years old (five-feet, three-inches) who lost 165 pounds after a gastric bypass. She had an L brachioplasty with liposuction. After photos are three years later. Note the inconspicuous location of the scar and lack of contracture across the axilla. The patient below is 46 years old and lost 70 pounds after gastric bypass. After photo is 14 months after an L brachioplasty with removal of 400ccâ&#x20AC;&#x2122;s of fat from each arm. She had an upper body lift with breast reshaping using a spiral flap and upper body lift

body language www.bodylanguage.net

59

surgery Dennis Hurwitz

antiseptic is painted circumferentially and then laid down on to an arm board covered with sterile drapes. Through puncture wounds on or near the medial and lateral condyles, saline with xylocaine and epinephrine is infiltrated throughout the upper arm until the tissues are turgid.

Approximately 1cc of fluid is infused for every cc of anticipated fat removal. Extra access incisions are made as needed.

After waiting at least 10 minutes, an ultrasonic probe is used to emulsify the excision site fat. The speed of probe movement adjusts to tissue resistance.

Regardless of whether the Lysonix 3000 or the Vaser is used, emulsification is complete when there is no further resistance to probe movement. Then the vibrating probe is passed through the cosmetic reduction portion until tissue resistance reduces.

Standard liposuction through a multi-holed 4mm diameter cannula aspirates the emulsified and residual fat throughout the excision site thoroughly, with care taken to avoid injury to the perimeter subcutaneous tissue that will be used for closure. A depressed trough is created with the skin lying directly on the muscular fascia. The cosmetic liposuction of both emulsified fat and residual fat sculptures the remainder of the arm.

Prior to excision of the defatted skin, the reduction is simulated with a tailor tack gathered along the anterior and posterior incisions. Assured there is adequate tissue laxity for closure, the posterior incision is made first through the skin and then subcutaneous tissue.

After another check of appropriate width of excision, the adjusted anterior incision is made. A final towel clip approximation of the wound edges is made and, since the initial width of

excision had been planned conservatively, at times an additional centimetre or two of excision along the anterior incision line is done. If the excision has proven to be too tight then some of the saved excised skin can be placed as a skin graft.

The anchor suspension closure is from the tip of the proximal triangular flap to the junction of the deltopectoral fascia. The alignment is hatch-marked for the running #1 PDO 48 centimeter Quill double-armed bidirectional barbed suture. The initial bite is vertical and from there serial deep horizontal bites of the subcutaneous tissue are taken away from that point.

The needle traverses closest to the dermis the farthest it is away from the wound edge. The next and final layer is a 3-0 bidirectional monoderm intracuticular suture that also starts in the middle. The wound is supported and sealed with a topical dermal glue. Six-inch ace is wrapped over fluffed gauze from wrist to axilla. Two to three days later the wrap is removed and exchanged for proper fitting elastic sleeves if the colour of the tip of the posterior triangular flap is healthy.

Complications have been few with edge skin necrosis of the triangular flap in 10 per cent of the cases and rare wound separations that are allowed to heal. There have been no skin tightening or contractures across the axilla. Satisfaction has been high with about 10 per cent of recurrent laxity and additional skin excision along the mid-arm.

Dr Dennis Hurwitz is the clinical professor of surgery (Plastic) at the University of Pittsburgh Medical School and runs the Hurwitz Center for Plastic Surgery, 3109 Forbes Ave, Suite 500, Pittsburgh, PA, 15213 USA; T: 866-473-2570; W: hurwitzcenter.com

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QEII CONFERENCE CENTRE, LONDON

THE UK’S PREMIER MEDICAL AESTHETIC C O N F E R E N C E AND EXHIBITION

21ST-23RD J U N E 2 0 1 3 THREE DAY CONFERENCE PROGRAMME Hear the world’s leading facial aesthetic experts speak on the latest developments in Facial Aesthetics. FACE will include many parallel lectures to allow all topics within facial aesthetics to be covered with even more exhibitor workshops and specialist meetings.

ADVANCED TRAINING

Opportunities to learn new and advanced techniques from leading practitioners in this limited space, full day training course. Advanced training will include injectables, lasers and skincare taking place through out the weekend.

EXHIBITION A much larger platform for the exhibitors at the QEII will allow delegates to see more than 70 key manufacturers and distribuotrs in the industry and any product specific workshops available through the weekend.

FACE OF THE CLINIC A concurrent business meeting providing an invaluable opportunity for you to invest in quality education for key personnel within your business.

SKIN Skin is the most visible organ affected by ageing and a variety of common skin diseases. 2013 will see lectures devoted to treating ageing skin, treating common skin diseases and dealing with the unique problems associated with treating skin of colour.

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NEW LOCATION FOR FACE 2013 FACE Conference has provided over 3000 delegates the chance to see some of the most enterprising speakers, treatments and topics in aesthetic medicine. In 2012 FACE celebrated 10 years and has eveloved with the very industry it serves. FACE 2013 will be moving to the QEII in Westminster, London to help accommodate the growing lecture programmes. With over 70 exhibitors and 100 hours of lectures by the worlds best practitoners and pioneers in facial aesthetics, FACE 2013 promises to be larger than ever.

“The FACE Conference is without doubt the premier facial aesthetic meeting in the UK. The unique contribution from all subspecialties makes FACE the best way to keep up to date.” RAJIV

GROVER, CONSULTANT PLASTIC SURGEON

“One of the best, most enjoyable, informative aesthetic meetings in the world.” DR TIMOTHY FLYNN, COSMETIC DOCTOR “The FACE Conference brings together National and International leaders within the cosmetic and aesthetic industry and year-on-year represents the ultimate forum for practitioners who wish to expand their knowledge base and practical skills.”

PROFESSOR SYED HAQ

surgery Dr Luiz Toledo

Brazilian

buttocks The pioneer of the Brazilian buttock technique revisits his procedure 25 years later. Dr Luiz Toledo says it still stirs debate at congresses despite years of success

W

e started using fat grafting in Brazil on a large scale in 1985. Initially, the technique was practised only occasionally for the face or to correct a liposuction depression. When we felt more comfortable with the aspiration and injection of fat, we started using larger volumes and were impressed by the good results and lack of complications of the technique. This is how the Brazilian Buttock technique was developed.

In 1985, we aspirated fat from the abdomen, waist and thighs and injected it in the buttocks for a firmer and perkier look. We had almost two years’ experience with the technique when we first showed it in 1987 at the International Society of Aesthetic Plastic Surgery Congress in New York.

My co-author was Matsudo, and we worked together at the time. Our paper, “18 months' experience with injected fat graft-

ing”, was published in 1988. The paper discussed our experiences with 208 patients of buttock augmentation and reshaping, filling trochanteric depressions, augmenting breasts, thighs, calves and ankles, improving scar depressions, and treating liposuction sequelae, fingers and hands. Fat was injected in the face to treat wrinkles and depressions, improve malars and zygomas, nasolabial and nasojugal folds, lips and eyelids.

At the time the only accepted procedure for volume augmentation was the insertion of silicone implants. We showed fat grafting could have major advantages with fewer complications.

We used fat for volume injection up to 450cc. Today we inject more than that, but it depends on several factors.

Now the technique is used in many countries, but when I started lecturing about it in the US in the late 1980s, Americans preferred women with bigger breasts and flat buttocks. Today

A RANGE OF PATIENTS PRESENTING WITH DIFFERENT CHALLENGES. Paired from left to right: 1) A 40-year-old patient with an android type of body and flat buttocks. Fat was aspirated from the abdomen, back and flanks and injected into the buttocks. 2) One year post-operative; two procedures six months apart. Patient had 900cc of fat injected into each buttock, 500cc on the first procedure and 400cc on the second.

Her hip circumference went from 108cm to 114cm. Her weight remained the same. 3) A 32 year-old patient with a gynoid body type. She needed fat aspirated from the abdomen lateral and medial thighs and injection in the buttock. 4) One year post-operative. To obtain a good contour, fat was aspirated superficially from the lower third part of the buttocks and 500cc injected in the upper two-thirds on each side,

62

body language www.bodylanguage.net

surgery Dr Luiz Toledo

this has changed, especially because of Latin stars such as Jennifer Lopez. Now, many patients from different countries ask for the technique.

When I lectured at the British Association of Aesthetic Plastic Surgeons’ congress in 2006 and presented the technique in the UK, not only plastic surgeons were interested. The media made a big fuss about the technique, and I believe this is when it became more acceptable in the UK. This technique became a necessity in Brazil, a country where a large portion of the population live on the coast and go to the beach regularly, exposing their bodies in very small beachwear.

Origin The origin of Brazilians’ fixation with a woman’s derrière is unknown. I have studied the work of many sociologists trying to understand why a woman’s first reaction when trying on a new outfit is to turn her back to the mirror to see what it looks like from behind, and why men always turn their heads to check the figure of a passing woman.

One explanation I came up with goes back to the slave trade.

Brazil was one of the last countries to abolish slavery in 1888.

Most of the slaves that came to the country came from a region in Africa where women have a lean upper body and heavy buttocks and thighs, the so-called gynoid type of body. The mixture of the Portuguese colonisers with the African slaves created a race with mostly fine waistlines and round buttocks.

Patients of the android type of body, whose concentration of fat is in the upper body and torso, have thin legs and buttocks that are not big. With the reshaping of the abdomen and waist, we can get the fat needed to inject half in each buttock. We know that 40–50% of the fat will be reabsorbed.

Some patients now want to have 1000cc of fat injected into each buttock. I tell them that, in most cases, the maximum amount we can inject in one procedure is around 500cc per side and that the procedure can be repeated after a few months. This is one of the common misunderstandings about the fat grafting technique. Patients don’t understand that, for the graft to take

giving the impression the buttocks have been lifted. 5) A 46-year-old with a gynoid type body. She needed fat aspiration from the lateral and medial thighs, posterior thighs and abdomen, with 400-cc fat injection into each buttock. 6) One-year post-operative. This patient also had the buttocks dimples treated to improve cellulite. This is done with a Toledo V-tip dissector cannula, breaking the adherences that pull the skin down and injecting a few cc of fat in the area to avoid re-attachment. It body language www.bodylanguage.net

and live, it is necessary to have a space around the graft with some free blood circulation, to allow for the neo-vascularisation of the graft. If we put too much in the same place, the fat won´t survive.

In our initial paper of more than 25 years ago, we stated the rules to obtain a good result with fat grafting. Some of them were: avoid high negative pressure during suction, avoid "collections" or "lakes" of fat, inject in "thread" shapes and hypercorrect 35% to 50% if possible.

The Brazilian Buttock technique of injection of liposuctioned fat was at first received with discredit and was accepted only after 25 years of showing good results. Today it has become one of the hottest topics in at every plastic surgery meeting.

Harvesting, cleaning and injecting fat is a simple procedure. I harvest fat from wherever I can find it. I avoid harvesting fat from the medial knees, an area that can easily show any depressions.

I avoid excessive manipulation of fat. I do not sieve, nor expose fat cells to air to avoid trauma and oxidation. When necessary I perform three sessions of fat injection, one every 50 or 60 days.

The syringes with fat are centrifuged at 1500 rpm for one minute, or they can be decanted for 10 minutes. The anaesthetic fluid is separated from the fat cells and the pure fat is gently transferred to a syringe attached to the pistol for injection.

Nutrition Fat graft's ability to obtain nutrition through plasmatic imbibition occurs approximately 1.5mm from the vascularised edge. I inject parallel threads subcutaneously, leaving space for neo-vascularisation.

New technologies of genetic engineering promise us even better results, however, adipose stem cells were described in the literature less than a decade ago and more research must be done to determine the safety of their use in humans.

Dr Luiz S Toledo is a plastic surgeon based in Dubai and spent many years practising in Brazil. T: 971 50 702 2780; E: ToledoDubai@ gmail.com; W: luiztoledo.com

does not solve the problem, but it does improve the area by about 50%.

7) A 50-year-old skinny patient who wanted to have bigger buttocks.

8) The patient one year post-operative. Fat was aspirated from the abdomen, flanks, lateral thighs and lower buttocks. The patient has had 200-cc of fat injected into each buttock. Our procedure involves injecting fat 3mm threads in layers, sub-cutaneously, into the adipose tissue and into the gluteus muscle 63

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A practical guide for aesthetic practitioners

01/05/2012

18:36:00

Keep up to date on all the latest developments within aesthetics and cosmetic surgery Body Language is a bi-monthly journal, with each issue featuring in-depth articles from leading practitioners detailing new and innovative procedures.

Practical techniques demonstrate exactly what surgery, products and technology can achieve, as well as:  Anti-ageing features demonstrate that old-age need not be a debilitating disease and instead is a treatable condition with positive results for long, healthy living  Dermal fillers and botulinum toxin advanced techniques in their application  Products and services tested and reviewed  Peer to peer - leading practitioners provide their answers to your questions  Analyses that keep you abreast of major developments

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BODY November 3rd & 4th 2012

R OYA L S O C I E T Y OF MEDECINE

CONFERENCE AND EXHIBITION

Shaping the future of aesthetics Exploring both surgical and non-surgical treatments in the rapidly evolving BODY aesthetic market

Four Years of Body

BODY provides a broader scientific agenda that brings all specialities together at one meeting to provide a unique opportunity for debate and to learn more about the specifics of the many different market segments that make up the BODY aesthetic market place. BODY 2012 will be the largest UK congress this year devoted to the rapidly expanding non-surgical and surgical BODY aesthetics sector of the cosmetic market, and is a must attend event for practitioners and clinics operating in this exciting market segment.

What to expect from BODY 2012 Medical Practitioners

• Two full days of scientific lectures and demonstrations based around the

An Evening With In 2010 BODY introduced the concept of ‘An evening with...’ and it was a resounding success with Dr Steve Mulholland as the star of the night with a two hour insight into the methods of creating a super clinic. With interaction from the audience it was a truly unmissable evening for all.

In 2011 we once again had one of the industry greats speaking and Prof Marco Gasparotti didnt disappoint! 2012 will make room for another of the industry greats to make BODY 2012 one of the meetings of the year.

C C Kat, Consultant Plastic Surgeon “A wonderful, one-stop, once a year update on state-of-the-art body contouring”

• International faculty of leading Dermatologists, Surgeons and art of body treatments • Wide range of key industry exhibitors showcasing the newest products available • Exhibitor workshops and demonstrations presenting the latest in techniques and tools needed to create the best results

Now in its fourth year, BODY 2012 is the sister conference to FACE – the UK’s largest conference on facial aesthetics. It follows the same format in aiming to provide the highest quality national and international speakers in their respective fields of scientific interest to update your clinical knowledge and explore new market opportunities in the dynamic BODY aesthetics industry.

Bruce Freedman, MD FACS “I believe that BODY Conference combines the latest in cutting edge technology, practical application, and international expertise in the field of body contouring. The knowledge from this meeting should markedly enhance every clinician’s practice.”

Shailesh Vadodaria, Reconstructive Plastic Surgeon “In the fourth year of the BODY Conference the panel of national and international experts will share their scientific experience and modern developments to enhance the aesthetic outcome of breast and body shaping surgery.”

BODY 2012 is brought to you by FACE Ltd the team behind the UK’s premier aesthetics meeting the FACE Conference

WWW.BODYCONFERENCE.CO.UK

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comment David Williams

Conclusion

BY DAVID WILLIAMS

Home-based treatments B

y using exaggeration in a cartoon, it is easy to lampoon the limitations of do-it-yourself cosmetic surgery treatments in the comfort of your own home. Invasive medical procedures that require anesthesia and surgical skill such as liposuction and face-lifts require external expertise and will continue to do so for the forseeable future.

Of course, how the procedure changes as a result of the application of new technology will affect the degree of skill required. Although it is safe to say complex invasive procedures will continue to be in medical practitioners’ hands for some time, don’t discount a shift to laypeople in years to come.

Just look at the procedures commonly performed at home. Hair removal used to require frequent visits to a practitioner’s office. Acne treatments demanded consultations with dermatologists or the use of specialist apparatus at clinics. Facial toning needed pricey electrical equipment. Now these procedures can be done at home with devices readily available.

Home and clinical devices are generally distinguished by power. This distinction arises because of safety, as mere home-based mortals are more likely to cause themselves injury, principally arising from over-zealous application.

Unit cost plays a large role, too, as the footprint of a laser, for example, provides a host of features small handheld units can’t… yet. Last year the Los Angeles Times assembled a panel of experts including a derm, surgeon, professor of dentistry and laser surgeon to assess whether new home-care devices could create results that rivalled clinics’.

Up first was a laser hair removal system, which the manufacturer claims is “the only FDA-cleared home laser removal system that provides permanent hair-free results”. The diode wavelength worked, but the spot size adjudged too small. Treating an underarm might not be too exhausting, but users will have to burn the midnight oil for more than a week to do their legs. Also, the machine didn’t work on dark-skinned patients.

66

Next, a battery-powered dermabrasive unit, with two foam-applicator attachments, a deep cleansing brush attachment and polishing crystals, would enable the user “after just one microdermabrasion treatment to see immediate improvement in pore appearance, skin tone and evenness, fine lines, skin clarity and brightness, and radiance”.

The experts concluded it would improve some signs of ageing, unplug pores and remove dead skin cells, but showed concern that some people might “overdo it”, particularly when trying to remove a wrinkle. I can picture that all too painfully.

An anti-aging starter kit and acne kit were more suspect. Both are light therapy devices that glow red (anti-aging kit) or blue (acne kit). You cover your face with “botanically-based, light optimised topicals” and hold the device over the targeted area for three minutes daily until changes in the earth’s climate turn Britain’s weather tropical. Actually, the laser expert said: “The regenerative red lightemitting diode has been shown in studies to stimulate collagen production. But it does it in such a microscopic way that you may not be able to notice anything macroscopical or in a photograph.”

The blue light was shown to vanquish P-acne cells, but again it could take the patient a few decades.

A teeth whitening light system provided results that aren’t too dissimilar to what can be obtained by a dentist. The hydrogen peroxide is the core of the system, which of course whitens teeth, but the accompanying whitening light was viewed with caution, as it is still debated whether light activation affects the whitening process. The heat from another system’s light source was seen as possibly effective, as heating peroxide can hasten its activity.

The article heads towards a predictable conclusion, quoting a practitioner sanctimoniously, saying the beauty industry is good at exaggerating claims to promote its products.

Really, though, he is deceiving himself if he thinks these shortcomings won’t be addressed. The driving force of free enterprise is to solve problems and make solutions available cost-effectively for the end-user with a large jackpot as the incentive. Technology will help companies to achieve their goals in the depths of the world’s oceans, in distant space exploration, and in the home-use aesthetics market. It is only a matter of time.

body language www.bodylanguage.net

Wigmore Medical Driving the medical aesthetic industry The longest established aesthetic distribution company in the UK, Wigmore Medical have over 30 years of industry experience • All your aesthetic supplies from one company • Free next day delivery on orders over £500 • Same day delivery within London on orders placed before 3pm • Always at the forefront of the market, introducing new and exclusive product ranges • In the heart of London in close proximity to Harley Street • Walk-in pharmacy for face-to-face personal advice • Exceptional Customer Service advisors with extensive product knowledge • We offer tailor-made product solutions, providing training on product ingredient to enable a mix and match range, making your practice unique whilst increasing revenue.

• Leading laser specialists on hand to advise with over 12 years experience

Extensive product range available including: • Skincare • Dermal Fillers • Botulinum Toxins • Laser/IPL • Microdermabrasion • Consumables • Chemical Peels • Medical Equipment

“The aesthetic industry’s favourite partner” Email for aesthetic order: orders@wigmoremedical.com Wigmore Medical, 23 Wigmore Street, London, W1U 1PL Tel: 020 7491 0150 Fax: 020 7491 2782 Email: customerservices@wigmoremedical.com Web: www.wigmoremedical.com

≤ 25°C

Bocouture® 50 Abbreviated Prescribing Information Please refer to the Summary of Product Characteristics (SmPC). Presentation 50 LD50 units of Botulinum toxin type A (150 kD), free from complexing proteins as a powder for solution for injection.

Indications Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar frown lines) in adults under 65 years of age when the severity of these lines has an important psychological impact for the patient. Dosage and administration Unit doses recommended for Bocouture are not interchangeable with those for other preparations of Botulinum toxin. Reconstitute with 0.9% sodium chloride. Intramuscular injection (50 units/1.25 ml). Standard dosing is 20 units; 0.1 ml (4 units): 2 injections in each corrugator muscle and 1x procerus muscle.

May be increased to up to 30 units. Not recommended for use in patients over 65 years or under 18 years. Injections near the levator palpebrae superioris and into the cranial portion of the orbicularis oculi should be avoided. Contraindications Hypersensitivity to Botulinum neurotoxin type A or to any of the excipients. Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome). Presence of infection or inflammation at the proposed injection site. Special warnings and precautions Should not be injected into a blood vessel. Not recommended for patients with a history of dysphagia and aspiration. Adrenaline and other medical aids for treating anaphylaxis should be available. Caution in patients receiving anticoagulant therapy or taking other substances in anticoagulant doses. Caution in patients suffering from amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction.

Too frequent or too high dosing of Botulinum toxin type A may increase the risk of antibodies forming. Should not be used during pregnancy unless clearly necessary.

Interactions Concomitant use with aminoglycosides or spectinomycin requires special care. Peripheral muscle relaxants should be used with caution. 4-aminoquinolines may reduce the effect. Undesirable effects Usually observed within the first week after treatment. Localised muscle weakness, blepharoptosis, localised pain, tenderness, itching, swelling and/or haematoma can occur in conjunction with the injection.

Temporary vasovagal reactions associated with pre-injection anxiety, such as syncope, circulatory problems, nausea or tinnitus, may occur. Frequency defined as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare

(≥ 1/10,000, < 1/1000); very rare (< 1/10,000). Infections and infestations; Uncommon: bronchitis, nasopharyngitis, influenza infection. Psychiatric disorders; Uncommon: depression, insomnia. Nervous system disorders; Common: headache; Uncommon: facial paresis (brow ptosis), vasovagal syncope, paraesthesia, dizziness. Eye disorders; Uncommon: eyelid oedema, eyelid ptosis, blurred vision, eye disorder, blepharitis, eye pain. Ear and Labyrinth disorders; Uncommon: tinnitus. Gastrointestinal disorders; Uncommon: nausea, dry mouth. Skin and subcutaneous tissue disorders; Uncommon: pruritus, skin nodule, photosensitivity, dry skin. Musculoskeletal and connective tissue disorders; Common: muscle disorders (elevation of eyebrow), sensation of heaviness; Uncommon: muscle twitching, muscle cramps. General disorders and administration site conditions; Uncommon: injection site reactions (bruising, pruritis), tenderness, Influenza like illness, fatigue (tiredness). General; In rare cases, localised allergic reactions; such as swelling, oedema, erythema, pruritus or rash, have been reported after treating vertical lines between the eyebrows (glabellar frown lines) and other indications. Overdose May result in pronounced neuromuscular paralysis distant from the injection site. Symptoms are not immediately apparent post-injection. Bocouture ® may only be used by physicians with suitable qualifications and proven experience in the application of Botulinum toxin.

Legal Category POM. List Price 50 U/vial £72.00. Product Licence Number PL 29978/0002. Marketing Authorisation Holder Merz Pharmaceuticals GmbH, Eckenheimer Landstraße 100, 60318 Frankfurt/Main, Germany. Date of revision of text FEB 2012. Full prescribing information and further information is available from Merz Pharma UK Ltd., 260 Centennial Park, Elstree Hill South, Elstree, Hertfordshire WD6 3SR. Tel: +44 (0) 333 200 4143 Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Merz Pharma UK Ltd at the address above or by email to medical.information@merz.com or on +44 (0) 333 200 4143.

1084/BOC/JUN/2012/JH

Date of preparation June 2012

Bocouture® is a registered trademark of Merz Pharma GmbH & Co, KGaA.