The Consulting Room™ Industry Magazine Edition 115, December 2012

[COVER]

From The Editor's Desk Welcome to The Consulting Room™ Industry Magazine For December 2012 Santa is on his way, so what do you want for Christmas? Appointment books bursting with clients for pre-party makeovers? A brand spanking new device in your stocking to delight in 2013? Well, to start off the present season for this December issue of our Member Magazine we have our ‘bumper’ Feature Article on the ‘nitty gritty’ of medical skin-needling devices. It’s a must-read to learn about the manufacturing processes, the drivers of quality, the regulation, the safety and the choice of brands available.

Our Food For Thought section this month looks at an interesting case which at first glance looked like an HA filler caused a stroke, deeper investigation reveals interesting cautions on patient consultation and consent processes. Our Business Corner has interesting coverage on the Harley Medical Group ‘takeover’ and Latest News includes details of a clinical trial on Cognitive Behavioural Therapy for BDD sufferers plus results of a survey from BAAPS looking at complications presenting to plastic surgeons from dermal fillers.

Lorna Jackson

This month’s Eye Spy With My Industry Eye features the much anticipated Aesthetic Awards 2012/13 hosted by Cosmetic News magazine.

As always the magazine is packed with Legislation, Clinical Information, Equipment Sales, and Interesting News Articles and Blogs That You May Have Missed.

Obagi UK Rep Janeé Parsons Tragically Killed Janeé Parsons, known to many as the Midlands Territory Sales Manager for Obagi Medical Products through the Health Xchange Pharmacy and as a Beauty Therapist was tragically killed at her home in Bicester, Oxfordshire on the morning of st Saturday 1 December 2012.

The 31 year old, American mother of two died from multiple stab wounds as confirmed by a post mortem. Her husband has since been arrested and charged with her killing. He will appear in th court again on 11 February 2013. Thankfully the couple’s sons, aged eight and five, were not in the house at the time their mother was killed and are being cared for my relatives. It is thought that financial pressures were the cause of a dispute which ended so tragically.

Many tributes have been paid to Janeé on social media sites by those in the aesthetic industry who knew her well; she will be sorely missed.

The Consulting Room™ would also like to express our deepest condolences to her friends, family and industry colleagues. We are of course all still in shock that sucj a tragedy could have occurred. May she rest in peace.

New Member’s Area is Launched!

The Consulting Room™ is pleased to announce the launch of our newly upgraded, feature packed Member’s Area.

Available only to you, Consulting Room subscribers, it is packed with all the great information and resources you have come to know and rely on including a database of clinical paper abstracts, a supplier directory, details of industry organisations and legislation, plus comparison charts for botulinum toxins and dermal fillers as well as financial reports for the industry. We also have an archive of past editions of this magazine, along with past feature articles.

As always you will need your login details provided as part of your membership to access this area, which you can do by visiting www.consultingroom.com/members.

With the new upgrade we are also allowing you to log in via one of two ways – using your traditional username and password or by using the email address attached to your account and the password.

We are also now employing cookies, for those who are happy to use them, which allows the site to ‘remember you’ so the next time you visit you won’t have to log in again, unless you actually logged out of the site on your last visit.

New additions included in this upgrade design include an ‘Ask Ron’ feature. So if you have got a burning question about the cosmetic industry or running an aesthetic business then you can 'pick our brains', specifically the brain of our Director, Ron Myers who has two decades of experience within the pharmaceutical industry, including being involved in the launch of Botox® into the UK market place in 1994 with Allergan; he also has a decade of experience in running a successful aesthetic clinic. As the man behind the project management of the UK's largest annual aesthetic FACE and BODY conferences he has his finger on the pulse of scientific knowledge and trends in treatments, products and devices.

Ron and The Consulting Room Team have access to a wealth of information and contacts relating to many of the aspects of running a medical aesthetic business, as well as knowledge of industry regulation and history; and if we don’t know, we’ll do our best to find out!

The new Member’s Area also includes a variety of ‘deals’ from industry suppliers which you can take advantage of, new deals will be highlighted on the home page of the Member’s Area and in the deals section so don’t forget to come back regularly and have a look at what’s on offer.

Of course, also don’t forget that this is where you can update your clinic profile listing to include the treatments, products and ‘which treatment?’ areas that you provide services for, along with your contact information and staff biographies. You can also load up to 6 images and 3 videos to truly highlight your clinic to potential clients.

Why not go and take a look at the exciting new look today!

www.consultingroom.com/members

Some Recent Blogs You May Have Missed Treatment for Facial Palsy is Deemed `Cosmetic` by the NHS; First-Ever Facial Palsy Charity Launched to Improve Quality of Care

by Lorna Jackson Facelifts, brow lifts, Botox and dermal fillers may sound like treatments from the realm of wealthy socialites and Hollywood actors but these, among other new and cutting-edge procedures influenced by the world of aesthetic surgery can be life-changing for those living with facial palsy. Over 100,000 people in the UK suffer with the condition due to myriad causes including cancer, injury, neurological issues, infections, strokes or syndromes.

However treatment is unfortunately deemed ‘cosmetic’ by much of the NHS and therefore largely unavailable. The UK’s first-ever charity dedicated to facial paralysis, Facial Palsy UK (www.facialpalsy.org.uk) has launched. www.consultingroom.com/blog/339

When a Cosmetic Surgery Clinic Goes into Administration

By Nigel Poole Q.C. The Harley Medical Centre Limited has gone into administration. Where does that leave those of its patients who have been dissatisfied with their treatment? www.consultingroom.com/blog/338

How Botox treatment recommendations from NICE changed the life of one headache and migraine sufferer

By Lorna Jackson Chronic migraines are believed to affect 1.6% of the UK adult population and can be debilitating for the individual, leading to a significant effect on their quality of life. Earlier this year, NICE (the National Institute for Health & Clinical Excellence) recommend the use of Botox® (botulinum toxin type A, manufactured by Allergan) for preventing headaches in adults who have chronic migraine for which the brand has a license. www.consultingroom.com/blog/336

A veiny issue - 10 things you didn`t know about varicose veins

By Mr. Costas Kyriakides Around 3 in 10 adults will, at some point in their life, develop varicose veins. But why, when so many of us suffer with the condition, are we still unsure about the causes and health implications? www.consultingroom.com/blog/335

The Consulting Room™ 3rd Annual Golf Challenge Day Whether you're an amateur or experienced golfer join us to eat, drink, play, relax, network and play a round of golf. After the success of the last two Consulting Room Golf Days in 2011 and 2012 we are pleased to announce the th date for our 2013 tournament: 18 May 2013 at Old Thorns, Surrey.

We will be looking for clinics to enter a team of two and to compete for the Consulting Room Challenge Cup. If you can't find a partner, we'll aim to find one for you on the day, which will be a great opportunity to enjoy a round of golf - with a competitive edge, whilst networking with industry colleagues and friends.

Members who book before 31st January 2013 will get a 15% discount on all packages. Spa options are available for non-golfing partners!

For more information and to reserve your place, please visit www.consultingroomgolf.co.uk

Looking For Best Prices on Toxins & Fillers? This Month’s Deals The Consulting Room™ Product & Price Comparison Charts for Dermal Fillers and Botulinum Toxins have been recently updated with some of the head line products highlighted below. Located in the Product Comparisons* section within our Members Area you can compare the prices and bulk deals available through direct purchase from manufacturers/distributors or through the major third party wholesalers and pharmacies such as Wigmore Medical Ltd, Health XChange Pharmacy and Med-fx. (*Login required.)

Prices ex.VAT Botox 100U / 50U Azzalure 2 x 125U (Twin pack) Xeomin 100U / Bocouture 50U

Restylane 1ml

Wigmore Medical

Health XChange

Med-fx

N/A £100.00 Buy 10 @ £84.00 each# £118.00 / £53.95 10+ Packs @ £107.00 each / 20+ Packs @ £51.00 each £55.00#

£140.00 / £76.01 N/A

£145.00 £95.00

N/A

£119.90 / £51.00

£83.24

N/A

£96.88

£72.00 Buy 6 Get 2 FREE* £93.35

Juvéderm Ultra 2 (2 x0.55ml)

st

st

# offers end 31 December 2012

* offers end 31 December

Nip & Tuck - Facts & Stats

40

£150,000

Number of men referred to a hospital in Bangkok, Thailand per month with side effects from selfinjecting genitals with oil, beeswax or paraffin.

Value of the business and assets of the Harley Medical Group during sale to Aesthetic & Cosmetic Surgery Ltd. Source: Leonard Curtis (Administrators for The Harley Medical Centre Ltd)

Source: Daily Mail

£26,000 Compensation awarded to man left with hyperpigmented scarring on his nose following dermabrasion.

Source: This is Plymouth

Pokertox

343

Latest buzzword for treatment from a Doctor in New York giving gamblers the ultimate ‘Poker Face’ with botulinum toxin.

Number of labiaplasties performed by NHS on girls aged 14 or under in the last 6 years according to British Medical Journal study.

Source: Huffington Post

Source: The Metro

Latest News Clinical Trial Looks at BDD in Young People A pilot randomised controlled trial of Cognitive Behaviour Therapy (CBT) for adolescents with Body Dysmorphic Disorder (BDD) is being undertaken by a multidisciplinary research team including both academics and NHS clinicians with expertise in BDD and related disorders, such as Obsessive Compulsive Disorder and Tourette Syndrome at the Maudsley Hospital in London. This team is heavily involved in research into BDD and related disorders and have published extensively in the area.

They aim to conduct the first ever randomised controlled trial which will investigate whether CBT treatment for young people with BDD is helpful. Anyone taking part in the trial will receive 14 weekly CBT sessions from one of their experienced psychologists, and follow-up sessions over the following year. Given the impact BDD tends to have on family life, family members are often also involved in treatment.

They hope that the results of this CBT trial will: a) provide evidence for the psychological management of BDD in young people; b) provide crucial information for future, more definitive trials; c) increase awareness of BDD among both professionals and the public; d) help disseminate evidence-based treatments for BDD across the NHS and; e) reach more people who are currently not in treatment or receive inadequate treatment.

The study has been reviewed and approved by the South East Coast – Kent Ethics Committee. They are inviting referrals to their clinic for children and young people between the ages of 12 and 18 who are or thought to be suffering from BDD. For more information please visit the website at http://ifeelugly.info

Channel 5 Gives Green Light to ‘Botched Up Bodies’ Documentary Channel 5 has given the go ahead for a two-part documentary from Transparent Television about the plastic surgery department at the Chelsea & Westminster Hospital in London.

Botched Up Bodies (two 60 minute shows) will air in 2013. The shows go behind the scenes at the Chelsea & Westminster Hospital talking to patients whose bodies have been disfigured by discount cosmetic surgery and the doctors who are charged with fixing the problems.

The programmes will examine the debate about whether Britain’s National Health Service should take responsibility for these cases or whether the unregulated private sector should be held accountable. Leading cranio-facial surgeon Niall Kirkpatrick, lead clinician for the Cranio-Facial Unit at The Chelsea and Westminster Hospital, said; “If we do not act to regulate the private sector this is the future for the NHS. The strain is just too much, not only on the NHS – hospitals and GP’s – but on the economy. Private cosmetic surgery is rife for abuse without proper regulations; this is a serious problem that will not go away.”

Michelle Chappell, Channel 5’s commissioning editor for News, Current Affairs and Documentaries said: “Botched Up Bodies highlights a growing problem faced by today’s cosmetic surgery industry in correcting procedures which have gone drastically wrong. Some of the cases are truly horrifying and these surgeons are turning lives around.”

Jazz Gowans, Managing Director at Transparent Television said; “People are still making mistakes and not asking questions or doing their research which means we are all sadly seeing an increasing element of our society, a generation of men and women, [who] will be disfigured forever.”

Dr. Mario Russo Back in Business Plastic surgeon Mario Russo is back in business following a GMC investigation. Dubbed ‘Dr Boob’ by his loyal fans he will continue to practice plastic surgery with no further restraints placed upon his license. Earlier this year, a GMC investigation temporarily put a hold on Mr Russo’s work while the enquiry was carried out. The GMC case has now been concluded and the surgeon’s suspension fully lifted after the GMC found that there was ‘no evidence’ to justify continuing it.

BAAPS Urges Reclassification of Dermal Fillers as Medicines Following Survey into Botched Treatments Seen By Surgeons With the Government’s enquiry into the marketing of cosmetic procedures in full swing, the British Association of Aesthetic Plastic Surgeons has unveiled new survey results detailing the staggering rise in problems stemming from non-surgical treatments.

The internal poll reveals the number of complications seen in the past year due to dermal filler injections, how many patients needed corrective surgery and identifies the BAAPS’ main concerns regarding the lack of statutory controls over these unregulated procedures.

A shocking 69% of surgeons saw patients suffering complications from just temporary fillers, while nearly half (49%) of surgeons saw problems with semi- or permanent fillers. Out of those patients who suffered problems with permanent substances, nearly nine out of ten (84%) required corrective surgery or were deemed untreatable due to the damage caused.

The last BAAPS survey on this theme was done in 2009 and showed only 23% of surgeons were seeing problems with permanent fillers and just under a fifth (19%) with temporary ones, showing that in the space of three years the numbers have doubled for the former and tripled in the latter.

Survey highlights: 

More than two thirds (69%) of surgeons saw cases presenting with problems stemming from temporary fillers (e.g., hyaluronic acids). The majority (57%) saw 1-3 patients with complications but a considerable 12% saw between 4-6



Well over a quarter (28%) of surgeons reported that in the past year 1-3 patients actually required surgery to correct the damage caused by temporary fillers.



Nearly half (49%) of surgeons saw patients presenting with complications from semi- or permanent fillers (e.g., Bio-Alcamid, Aquamid). The vast majority (41%) saw 1-3 patients, 8% between 4-9 and one surgeon had seen more than 15 botched cases in one year.



Almost as many (41%) surgeons reported they saw patients who either required corrective surgery or were deemed untreatable due to the damage (this equates to 84% of all patients who presented with problems caused by semi- or permanent fillers)



A similar number (45%) reported seeing complications from body contouring filler Macrolane, which had been widely promoted as the ‘lunchtime boob job’. The majority (38%) saw 1-3 problem cases, whilst 8% saw 4 or more. The injectable was pulled off the market for use in the breast in April this year.



The top reasons surgeons feel complications occur with injectables are: 1.

2.

3.

4.



Unqualified practitioners are administering fillers incorrectly Lack of regulation has allowed unproven substances to be used in the UK Patients think of them as an easy treatment that can be administered by anyone Patients are unaware of the risks and side effects involved with the procedure

Nearly all BAAPS members (98%) feel that when fillers go through the approval process, they should be treated as a medicine (as is done in the US with the Food and Drug Administration) and that the current approval process, in which fillers are treated as a medical device receiving a CE Mark, is inadequate.

Consultant Plastic Surgeon, Consulting Room™ Adviser and BAAPS President Rajiv Grover said; “Although it is known that plastic surgeons are not the main providers of cosmetic injectables – in fact, a considerable number of respondents in our survey clarified they did not perform them at all - it is surgeons who are called upon to deal with problems when they do arise. The growing popularity of these non-surgical treatments has clearly led to complacency regarding how they are performed and by whom. As shocking as these figures may appear to the public, none of us in the profession are actually shocked by the results of this survey. The BAAPS has been voicing concerns over the lack of regulation in this arena for years - the statistics simply prove what we’ve been saying all along. What I would find surprising is if anyone was still able to maintain, in good conscience, that fillers should not be reclassified as medicines.”

Feature Article The ‘Nitty Gritty’ of Medical Micro-Needling Derma Rollers Do you know what you are you really buying?

Medical skin needling, also referred to as collagen induction therapy, percutaneous collagen induction or simply microneedling is a treatment area which has grown exponentially in the last 5 years.

Aimed at stimulating the body’s own collagen and elastin production for the treatment of everything from fine lines and wrinkles to stretch marks, scarring and hair loss, the treatment is performed through the insertion of a series of fine, sharp needles of varying lengths, mounted on a roller device which travel into the epidermis and/or dermis as the roller is moved over the skin’s surface.

Skin needling rollers, also referred to as dermarollers (derma is the Greek for skin) are available in needle lengths categorised for clinical, medical, surgical or home use (cosmetic/personal).

In this article, we are not aiming to discuss the treatment methods, the actual effect on the skin structures, or indeed the effectiveness of treatment alone or as an adjunct to topical treatments or similar. As more and more clinicians are embarking on offering this service to their clients, both through in-clinic treatments and with at-home skincare products and home use rollers, so a myriad of devices has been launched to the UK marketplace through a number of wholesalers and distributors. That’s not to forget the abundance of online providers of medical needling rollers busy touting their cheap and generic wares from far flung countries in Asia.

So what we really need to know, is the ‘nitty gritty’ of the difference between the devices, how are they made, what’s good, what’s bad and what do you, as an aesthetic practitioner need to consider when buying rollers to use on your patients. With the help of various skin needling device manufacturers and distributors we have put together some of the key things to consider and suggest that this is an article that you really must read; despite its ‘book like’ nature, I urge you to get a cuppa and keep reading!

Design, Manufacture & Quality This is the foundation of a micro-needling device, like anything you buy, a poorly designed and made product, using cheap materials will both not do the intended ‘job’ to the levels that you might expect, but in the worst case scenario could cause harm.

Whilst there is no specific definition of a micro-needle, they are generally fine needles with a shaft diameter of between 0.1mm and 0.25mm. Properly designed micro-needling devices require medical engineering, from the materials used to the number of needles created.

There are currently two main methods of manufacture; grinding and stamping.

Despite their application, micro- needles should in-fact be atraumatic, so a fully validated grinding and construction process is preferred over either a stamping or cutting production in the best quality rollers. Unfortunately we are unable to ascertain the exact needle processes used by each of the individual brands sold to the UK market, however generally it is thought that most needles produced globally are done so by mechanical pressing or stamping, with only a few key brands adopting the grinding method.

Grinding of the needles normally requires the stainless steel to go through a tempering/hardening process to enable each needle to be ground to an incredibly fine point, about 2 - 3 μm tip radius, in order to conserve tissue and minimise “tearing” or ripping of the tissue as they enter and leave it when the device is rolled over the skin.

Needles used in the needle disk system (such as in the DTS/GENOSYS roller) are stamped from metal sheets approximately 0.16 – 0.25mm thick. Essentially these are not needles but better described as spikes like those on a cog. The manufacturer makes the claim that the tip of the spike has a "mosquito" diamond shape that enhances penetration but a counter argument is that the fact that they are stamped and do not go through a secondary hardening and sharpening process means that the points are not considered to be sharp, plus they are also felt to be too close together.

This combined with the number of needles (more information on this below), means that their action on the skin is more traumatic as too much pressure is required in application, rather than the less traumatic performance of a ground micro-needle produced system.

Testing of needle disk systems by Dermaroller GmbH shows that the metal is softer and bends more easily than the steel used for grinding.

Image of a disk from a Disk Needle Therapy System (DTS) roller

Pangaea Laboratories also noted that there have been no trials using this system and that they have concerns over the safety of this device.

The needle lengths range from 0.8 to 3.0mm. The cutting edges of such needles can measure 0.16mm plus. This is 50 times wider than the 0.003mm tip radius of a ground, precision micro-needle as illustrated in this image.

In many of the imported devices from the Far East, the finish tends to be quite rough and so the needles are often coated or plated and/or polished. This gives a smoother, shinier finish but will give a blunting effect to the needles. There is also uncertainty about the materials used, which can include copper and nickel which is used to avoid corrosion.

Stamped versus ground needle

Most needles used in the wide range of generic rollers produced in China and India are more like industrial pins than needles. See example images below, for typical examples of rollers manufactured in China and India which clearly show irregularities in the needle shafts. These images show a brand from India called DERMAL ROLLER.

Number of Needles Contrary to popular belief, having a greater number of needles in a medical skin roller is not beneficial. Having more needles actually requires a greater force to be applied to penetrate the skin; meaning the procedure will be more painful and/or proper needle penetration will be difficult to achieve. It also means that there are a greater number of needles trying to enter and exit the skin at any one time which increases the risk of tearing or shearing of the skin tissues. The main dermaroller brands available on the market do display a variety of different needle configurations but popular layouts include 192 needles, those manufactured from disks tend to have more.

It is also critical that every needle is the same length; a lack of uniformity in the length of the needles could lead to an inconsistency in the penetration and a reduction in the efficacy of the treatment. Assessment of a variety of rollers by Dermaroller GmbH has shown that needle length is not always consistent.

Angle of Needles The optimum angle to have between each needle on a micro-needling device is between 15 and 20 degrees (for example, the Genuine Dermaroller™ brand has an angle of 20 degrees and the DTS/GENOSYS device declares an angle of 6 degrees on their website). At the optimum angle range, minimum penetration force is required as only one needle will be entering the skin at any one time, as shown in the image below.

The picture on the left hand side is a visual representation of a roller with a larger number of needles and consequently with a lower angle of separation between the needles. This angle will require greater force to be applied in order to get all of the needles into the skin. So essentially the greater the angle between the needles and the fewer there are (within reason) the better, as this requires the least pressure to apply treatment and will minimise any potential excessive trauma to the skin.

Materials, Construction & Quality Control All skin needling devices have similar components; a plastic roller and micro-needles, which depending on the method of manufacture are either glued in place or embedded directly into the plastic roller. The preferred solution would be the embedded option as this method is believed to be more secure, in that there is less chance of the needles becoming loose.

Rollers manufactured using the needle disk system separate each of the stamped metal disks with a small disk of plastic.

High quality stainless steel is the appropriate material for micro-medical skin needles – alloying elements of chromium, nickel, molybdenum and titanium. The chromium enables the metal to maintain its scratch and corrosion resistant surface and the molybdenum and titanium increases the hardness of the metal and helps to maintain a cutting edge. Chromium and nickel are the primary alloys in the majority of corrosion and heat resistant stainless steels. The nickel is required to stabilise the structure and add to the material’s strength, it is effectively locked in to the structure of the metal so that in most stainless steels there is virtually no risk of nickel allergy. (Care does need to be taken if a needle is "coated" and assurance that this does not contain nickel should be sought.) The molybdenum adds to the hardness primarily as it increases it's durability under high temperatures which are often required in the tempering/hardening process. When titanium is used as an alloying agent it is typically less than 1% (0.25 - 0.6%) and enhances the effect of the chromium and therefore corrosion resistance of the stainless steel.

This type of steel is ideal for medical instruments as it is strong, easy to sterilise and is resistant to corrosion. In terms of marketing claims, be aware that there is no such thing, from a legal standpoint, as ‘medical grade stainless steel’. Various stainless steel ‘recipes’ have been created and have been used in medical equipment for many years, thus proving their long term safety, but there is no singular steel alloy claimed as medical grade. Any new proprietary formulas must satisfy various standards authorities before being granted a clearance for use in medical applications.

The steel needs to go through a strengthening and tempering process to provide the strength needed to enable them to be ground and processed to the required sharpness. This also means that they stay sharp and are not compromised during the procedure.

Titanium is stronger than some steels and approximately 45% lighter. Due to its biocompatible nature it is used in a range of surgical tools and surgical implants. Often mixed or alloyed with other metals, these alloys are very strong

and tough even at high temperatures. The high cost of the raw materials and their processing make them prohibitive for many applications and industries and also increases the brittle nature of this metal if too much is used. Traders from China often claim that their devices are made from titanium. There is no evidence to prove this and it would seem highly unlikely as the material cost would be far too expensive and very difficult to tool due to breakages. Some products do contain a small percentage of titanium as part of the stainless steel alloy however, but levels do vary.

The plastic roller or barrel are made from a number of differing plastics such as ABS and MABS plastic or resin, with the cheaper Chinese or Indian imported rollers using inferior plastic compounds. Many of the higher quality brands use Lexan速. Lexan is the brand name for polycarbonate sheet and resin in a wide range of grades. Lexan is mainly used in things like space and sports helmets, clear high-performance windshields and aircraft canopies, motor vehicle headlight lenses, and bullet-resistant windows! The Lexan grade of plastic allows for irradiation and other forms of sterilisation without degrading or discolouration so is favoured by leading brands. MABS is widely used in medical and diagnostic products and is also capable of sterilisation by irradiation.

Sterility The credibility of claims regarding sterility also needs considering and it is wise to understand and be clear about the difference between cleaning, disinfecting and sterilising.

A sterile product is one that is free of viable microorganisms, including spores. The level/dose of the particular process used must be sufficient to eradicate all viable microorganisms and render the item sterile. This should be a validated process in which the known starting bio-burden has been rigorously tested at the process level/dose. The dose would need to also have been tested in the packaging and the format in which it is processed; this is normally done through dose mapping. The packaging seal/closure system around the device also needs to have been tested and validated, as should the claimed shelf life. Once validated, the starting bio-burden, the required dosing throughout the process and the packing configuration should be tested and approved for each batch/lot of production. There are 4 main methods of sterilisation; irradiation, heat, gas and chemical.

Irradiation Gamma rays and electronic beam processing are commonly used for the sterilisation of disposable medical equipment such as syringes, needles and cannulas. This should be done at an approved site at a validated dose and process.

Heat When using heat to sterilise, the most commonly used method is an autoclave. Pressure sterilisation is the chosen method for medical sterilisation of heat resistant devices. For any method of moist heat sterilisation, biological indicators are used to validate and confirm the process. When using biological indicators, samples containing spores of heat-resistant microbes are sterilised alongside a standard load. A colour change in the control indicates the presence of bacteria as does the appearance of cloudiness which indicates light scattering by bacterial cells.

Either of these changes is indicative of the fact that the sterilisation process has been ineffective.

Autoclaving can be done on an industrial or clinic scale. Again this process needs to be a validated one, from dosing through the process, to packaging and storage.

Gas Gas sterilisation can be used for materials and items that are sensitive to higher temperatures or radiation i.e. plastics and electrics. Ethylene Oxide (EO) is a common gas used in this process as it penetrates well, kills all known viruses, bacteria and fungi, including bacterial spores and is compatible with most materials including medical devices, even after repeated applications.

The downsides are its highly flammable nature, levels of toxicity and the fact that it is a carcinogen. Because of this it is normally reserved for heat/gamma sensitive instruments. A typical sterilisation process using EO consists of three stages; pre-conditioning, sterilisation and a period of post-sterilisation aeration to remove all toxic residues.

EO is still widely used by medical device manufacturers for larger scale sterilisation.

Chemical Chemical sterilisation is achieved using chemicals such as Chlorine releasing agents or Peracetic acid. These tend to be corrosive so are limited to materials that can resist such challenges and those that are intended for home use as this the most convenient method in such an environment e.g. baby feeding bottles and equipment. Less corrosive agents such as Gluteraldehyde require special handling and holding environments, they are usually limited to specialist hospital areas.

It should be noted that alcohol is not a sterilant but a disinfectant.

One needs to be careful when considering claims of sterility as it is an absolute status. For example, a claim to maintain sterility during re-use without the product going through a validated resterilisation process would be misleading and false.

Also when looking at the different methods of sterilisation is there one that suits all component parts of a device?

Heat and chemicals may not be appropriate as they can damage or change the structure of certain plastics and metals and gamma radiation equipment is not readily available for most clinics! Some rollers do come apart to enable separate processes of sterilisation to be effectively achieved for the various parts but those rollers which are one, fixed unit are normally sold as single-use and advice given in training courses or by distributors to go against this should be avoided.

The dangers of re-using micro-needling devices, even on the same person, without adequate sterilisation or misusing a single use device on multiple people were highlighted by a piece in the Daily Mail (Chinese women warned over 'potentially lethal' microneedle roller after beauty treatment takes Hong Kong by storm) which described how beauty salons in Hong Kong were performing micro-needling treatments and using the same device (the MTS Roller) for numerous patients. The salons were not sterilising these devices leading to infections in a number of people having the treatments. Hong Kong’s Consumer Council branded the treatment as ‘potentially lethal’ following a number of complaints. This simply gives the procedure an unnecessary bad dose of PR. The responsible way to perform these treatments, if the roller cannot be re-cleaned by a validated procedure such as cold sterilisation or autoclaving which would mean that the same roller could be reused on the same patient, is in a clinical setting with a sterile, single use medical device by a suitably qualified, experienced and trained practitioner.

Home use rollers cause other issues with hygiene as many come with an often untested, proprietary sanitising solution, or offer no solution and suggest consumers use baby sterilising solution. The problem with the latter is that the roller has not been tested with baby sterilising products to ensure either proper cleaning or compatibility. It is widely known that baby bottle sterilising solutions use chemicals which are highly corrosive to metals while being gentle on the plastic of the typical baby bottle. It should be noted that home use roller should be specifically designed for that use and not penetrate beyond the epidermis and thus make contact with dermal tissue or blood supply, needles that are longer than 0.2-0.3mm will do this. Devices that are sold for home use greater than this length and make claims for re-sterilisation at home should be avoided

Medical Device Classification & General Product Safety According to the European Union Medical Devices Directive; ‘Medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: 1.

2.

3.

4.

Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap Investigation, replacement or modification of the anatomy or of a physiological process Control of contraception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Medical devices are regulated under the provisions of a number of EU directives, covering different categories of medical device. The 4 categories are: 1.

2.

3.

4.

Class I = a plaster, a pair of glasses Class IIa = disposable contact lenses, syringes, micro-needling devices Class IIb = dermal fillers, gastric bands, lasers Class III = breast implants, hip joints

A manufacturer of Class I devices can self certify their compliance to the EU directives. All other classes of device need assessment by an independent third-party organisation known as a notified body. A notified body is a private company regulated by the member states competent authority, in the UK the competent authority is the MHRA.

With the CE marking on a product, the manufacturer declares that the product conforms to the essential requirements of the applicable EU directives. When certified by a notified body, the notified body’s number will be displayed alongside the CE mark. Medical devices have to comply with ‘essential requirements’. They must be safe and must function in a medical-technical way as described in the manufacturer’s ‘intended purpose’.

CE marking is a validated process that documents how a product is manufactured. It also provides batch/lot traceability and ensures consistency across a batch. Having a CE mark should mean that the process of sterilisation and manufacture has been validated by the notified body.

Whilst CE marking is a good starting point when looking for a medical device it is neither a definitive solution nor a guarantee of quality. CE marking should assure sterility of the device and consistency through the manufacturing process but it unfortunately does not necessarily determine how good or effective a device or the method of manufacture is.

The CE mark is designed to give consumers the absolute assurance of medical quality. Ironically, while the principal of one standard for all of Europe is signified by the CE mark, there is regrettably a variance in standards of the various notified bodies. Some are more lax than others. We have seen recently, failures in the monitoring and surveillance by the notified body and competent authorities with the PIP breast implant scandal. Unlike with medicines, notified bodies or certifying bodies are one step removed from the competent authority in a given country. The MHRA conducts periodic audits of notified bodies; it does not conduct its own assessment of data on safety and effectiveness of devices.

Experience has shown that the MHRA essentially takes the position that it has no jurisdiction or control over devices used for ‘cosmetic indications’.

This would not be the case for a medicine, which would be classified as such by its ingredients, mode of action and safety and raises questions over how well the supply of devices into the aesthetics industry is policed and how the reliability of suppliers can be guaranteed.

If we return to the specifics of skin needling, the MHRA have made it clear they have no interest or jurisdiction if the device is used for ‘cosmetic indications’ regardless of the fact that it is attempting to achieve a physiological and anatomical change to the human body and is thus deemed by many to be ‘medical’.

Currently any person can perform a procedure and any device, which does not make a medical claim, can be sold outside of any medical regulatory control. Thus this then falls under General Product Safety Regulations 2005, which requires that a producer does not place a product on the market, supply a product or offer or agree to do so for another entity unless the product is a safe product. This level of general regulation is much harder to police and validate.

If we look at the procedure, in-clinic needling requires; surface anaesthesia using a pharmaceutical product, multiple needle penetrations into the dermis, clinical end points including pin point bleeding, a pre-treatment consultation regarding patient suitability and contra-indications and potential management of complications.

The treatment goal is collagen stimulation and regeneration, angiogenesis and extra-cellular matrix regeneration.

Surely a responsible position is that these activities should be carried out in a clinical setting with a medical device and by a suitably qualified, experienced and trained practitioner. We do however have to remember CE marking is only a starting point and is open to, on occasion, fraudulent or misleading claims. For those that do not carry legitimate CE mark medical device classification there is virtually no policing of claims made by manufacturers.

Broad technical and methodological claims can be made without verification.

General Product Safety regulation falls under the remit of local authorities and Trading Standards, many argue that it is very questionable as to whether they are appropriate bodies to investigate or monitor these issues.

Examples to justify this point of view would be claims regarding the materials of manufacture, the sterility, the methods of use, e.g., which needle lengths are appropriate for home use/professional use, re-use (with or without validated cleaning and sterilisation processes and proof of product quality maintenance), who can use them, as well as the management of potential adverse events and complications. It’s easy to see that this could well be a task too far for Trading Standards.

Interestingly, as a comparison, according to the Canadian equivalent of our MHRA regulator, Health Canada, dermal rollers make health claims about what their products do, so that places them in the same class as a medical device requiring a license. They do not consider them to be cosmetic. Thus, a roller without a license from them cannot legally be sold.

Brands Naming conventions and trademarks are also an issue for this area; the word ‘dermaroller’ cannot be trademarked alone as it is deemed to be a generic term to describe the item; as mentioned previously dermaroller equals skinroller which is an exact definition of the item, much like ‘Hoover’ is a trademarked brand but ‘vacuum cleaner’ which describes the item is not.

The German Dermaroller GmbH company claim to be the first to have used the ‘Dermaroller’ name and to have registered the first web domain using the word in 2000, a patent was submitted in Germany in the same year and granted in 2005.

According to them, the name quickly became a descriptive term for the similar devices that soon followed with widespread use on the Internet. In Europe there is a registered Dermaroller trademark combining the word with a logo design, as used on the Dermaroller GmbH packaging. In the UK the trade mark Genuine Dermaroller™ has also been used alongside this to try and differentiate the devices. The Dermaroller company does own a registration of the Dermaroller trademark as a word in the USA but the widespread use of dermaroller as a descriptive term and the high cost of litigation to protect the mark has resulted it in it becoming the ‘Hoover’ of the skin-needling market where the only winners are lawyers lining their pockets with cash. A variety of combinations of brands do exist featuring similar wording like ‘derma roller’, ‘dermal roller’ or ‘dermarollers’ to avoid potential legal confrontations as have happened in the past.

There are now a large number of distributors supplying skin needling rollers to the UK aesthetic industry. The following information is designed to give a brief overview of the main brands (a non-exhaustive list in alphabetical order) including details of their construction, their licensing and any claims that they make in their marketing. For more details of each brand, we would recommend visiting the associated website and contacting suppliers listed.

DermaPure Pure Roller The DermaPure Pure Roller is distributed in the UK by DermaPure Ltd, through their Hop Clinic Essentials operation. The rollers are not CE marked. They are marketed on the packaging as ‘the pure titanium micro roller system’ and their website claims they use ‘ultra fine titanium needles’; however, the use of high levels of titanium within the needles is doubted within the industry and independent testing has shown that the level does not conform with a medically approved stainless steel grade.

The rollers use 200 needles (of 0.07mm diameter) with home use products available from 0.25mm. The supply of longer needle lengths, up to 3mm is to clinics only. www.purerollers.com

Dermal Roller SR™ Dermal Roller SR™ is manufactured by Prollenium Medical Technologies Inc. who are based in Canada and distributed in the UK by Boston Medical Group Ltd. Their single-use professional rollers have 192 needles and are made from Japanese surgical steel with a nickel percentage of around 1.5%, which the manufacturers claim makes incidents of allergic reaction almost impossible.

Professional use rollers are available in lengths of 0.5mm, 1mm, 1.5mm, 2mm, 2.5mm and 3mm. Training is provided to registered medical professionals and beauty therapists at NVQ level 2 & 3. Home use or cosmetic rollers are also available in lengths 0.2 and 0.3mm to be used in conjunction with a sanitising solution.

The device has courted some controversy in respect of its licensing and registration both in Europe and in Canada. At various points both packaging and instructions for use documentation contained within the packaging had included a CE mark, alongside the number for two notified bodies, SGS and MED/CERT, both of whom deny ever issuing a CE mark to any of the companies involved in the production or distribution of the product. When questioned about this, Boston Medical Group said; “as soon as we became aware of this issue, the entire batch was withdrawn although a small amount had already been dispatched. This was a printing error as the CE mark related to an injectable product.” (They also distribute the Revanesse® and Redexis® brands of dermal filler from Prollenium.) Both Boston Medical Group and Prollenium have confirmed that the Dermal Roller SR does not have a CE mark.

Additionally, in Canada, the device had its medical device license withdrawn in September 2010 due to “a lack of assurance of sterility”; therefore it can no longer be sold in Canada. The company’s response is that in order to comply with Health Canada, it would have been necessary for the product to be blister packed sealed. The decision was taken that as 99.9% of sales are generated throughout Europe, Asia and South America where the manufacturer compliance was acceptable in all these regions, it was therefore felt that there was no need to change manufacturing/packing process to satisfy the Canadian market. They also wanted to point out that there has not been even one case of infection or complication associated with this manufacturing process and safety of their clients is their utmost priority. www.boston-medical-group.co.uk

Environ Roll-CIT™ Often considered as the father of all medical skin needling rollers, due to the invention of the dermaroller concept by Dr Des Fernandes, a South African Plastic Surgeon who conceived the idea originally using a needle stamp in the mid-1990s, the Roll-CIT™ (the abbreviation of Collagen Induction Therapy) is designed to be a reusable device.

However, it is noted in the promotional materials from the manufacturer Environ that they are to be used for the same patient. The roller heads are detachable and are sterilised with a chemical sterilant between uses. The handle can be sterilised by using an autoclave.

Rollers are available for cosmetic use and include an innovative, patent pending, two headed roller (the Body Roll-CIT™) with a needle length of 0.2mm.

Professional use rollers for medical procedures are split into a medical model with needle lengths of 1mm and a surgical model of 3mm. Both of which have supply restricted to doctors and trained medical staff. www.environ.co.za/products/medical-roll-cit

GENOSYS Developed in 2008 and originally known as the DTS (Diskneedle Therapy System), it was rebranded as GENOSYS in 2010 and is manufactured in South Korea. It is CE marked through the notified body SGS. The GENOSYS dermarollers are manufactured using the disk needle system with 9 disks, each housing 60 needles, giving a total of 540 needles. Needle lengths of 0.25mm for personal use and 0.5mm, 1mm and 1.5mm for professional use are available and sold to licensed skin professionals only. A vibrating roller is also available. Expect to pay about £35 per roller. www.genosys.info

Genuine Dermaroller™ Known as the market leader, Genuine Dermaroller™ makes the claim of being the first micro-needle device to be CE marked as a medical device. It is manufactured in Germany by Dermaroller GmbH using their Medizinish Nadel Technik™ medical-needle technology and distributed in the UK by Aestheticare, a division of Ferndale Pharmaceuticals Ltd. Dermaroller GmbH is ISO13485 certified for the production of Dermarollers by the notifying body Med/Cert.

Needles in the Genuine Dermaroller are ground from high strength stainless steel. The stainless steel needles go through a 6 stage process to ensure this strength and sharpness is achieved. All medical and home use devices manufactured by them use an inter-self locking system to minimise as much as is technically possible the risk of needles detaching from the roller head. They claim this to be a further advanced technology than glue which is used in other ground micro-needling devices.

The 1.5mm medical roller has 9 needles per row, with 18 rows, making a total of 162 needles in the device. Needle lengths are available for 0.5mm, 1mm, 1.5mm and 2.5mm. The angle between the rows of needles is 20 degrees which is greater than most devices, this is claimed to enhance penetration and minimise surface trauma.

Supply in the UK is restricted to trained and authorised medical aesthetic clinics and practitioners. Home use products are also available and supplied to the public through authorised clinics. Expect to pay around £50 per roller. In-house training is available.

A new addition to the Genuine Dermaroller™ family has also been announced which will be available from January 2013, called the eDermastamp™. This CE certified medical device is an electronic microneedling device using the same Medizinish Nadel Technik™ needle tips.

It consists of a handpiece with single-use tips, motor, keypad control and display which allows the needle length to be precisely adjusted (to a maximum of 1.5mm) and ensures that the speed is fully controllable. The tips also provide a “window” in the tip body to allow skin-enhancing topical serums and products to be infused around and via the micromedical skin-needles if desired. www.genuinedermaroller.co.uk

Lotus Roller® The Lotus Roller® dermaroller is distributed in the UK by White Lotus Antiageing. The roller contains 192 stainless steel needles with a maximum needle length used of 1.5mm, as according to their philosophy of holistic microneedling there is no need to induce the trauma caused by longer needles. They also have a minimum length of 0.5mm, noting that anything below that length doesn’t induce collagen. Their needles are also quoted as 0.3mm in diameter.

In the past White Lotus have claimed in advertising that their roller is CE marked by the notifying body TUV Rhineland in Germany, yet when approached TUV said they do not record the Lotus Roller as a device, although they do certificate the Chinese manufacturer of the product. It is therefore felt that the labelling is not compliant with the CE marking process and certification; however TUV Rhineland are not taking matters further.

In-house training courses are open to beauty therapists with NVQ level 2 and above, those with level 2 must also have 3 years industry experience, as well as acupuncturists and medical professionals. www.whitelotusantiaging.co.uk

Medik8® Titanium Dermaroller The Medik8® Titanium Dermaroller is produced by UK based company Pangaea Laboratories who produce the Medik8 brand and is distributed in the UK by SkinBrands Ltd. The needles used in the device are engineered and ground in Sweden from a titanium alloyed stainless steel.

According to the manufacturer, the level of titanium in the Medik8 roller is deliberately small and precisely controlled (they wouldn’t tell me how much as understandably it’s a commercial secret). This, they claim, is to ensure that the properties of this stainless steel grade are maintained, resulting in a harder material which can be sharpened to a finer point, as well as a less corrosive material which reduces the amount of microscopic pitting, (especially useful on reusable home use rollers), than normal stainless steel. Controversies over marketing claims

for the product such as statements stating ‘engineered in Sweden from pure titanium’, and its actual brand name have led the company to clarify the situation and any misunderstandings by saying; “our needles are not ‘pure’ titanium but made from ‘pure’ titanium (within the stainless steel)”.

The micro-needles are also gold plated to help maintain a clean surface. The roller consists of 24 needles in a row with 8 rows on the device, giving a total of 192 needles in a diamond pattern. It uses three independent fixing mechanisms including gluing, plastic embedding and disk riveting to ensure the needles stay in place.

Needle lengths are available at 0.2mm and 0.3mm for personal use, 0.5mm for clinic use by Beauty Therapists and 1mm, 1.5mm, 2mm and 3mm (the latter two being indicated for use on the body) are for medical use only, although some therapists do qualify to use a 1mm roller according to the distributor. Training is provided free of charge alongside an opening order. Expect to pay approximately £25 per roller.

Pangaea Laboratories gave us exclusive news that they will in fact be launching a newly designed and upgraded skin needling roller in the New Year (2013) under the brand name Medik8 Titanium Skinrölla®. There will also be a special edition for the scalp, for hair loss indications, called Nanogen Titanium Scalprölla®. Both the medical and home use versions of the Skinrölla will be a CE mark certified medical devices (by a British notified body) along with the cleaning solution for the cosmetic roller. In fact, only the new Skinrölla offers a CE marked sanitising solution for use with the home roller, which is not the case with other proprietary solutions sold. Additionally the device comes with a detachable head design which allows people to buy one handle and refill it with roller heads.

Pangaea Laboratories themselves will be certified to be an ISO13485 medical device manufacturer, whereby the production is fully audited and the products are made in ISO certified clean rooms.

Pangaea told us; “the rigorous and painstaking lengths we have gone to over two years to meet standards that are not even a legal requirement are testament to our commitment to safety, the industry and our brand reputation.”

The barrel of the roller is made from the medical grade polycarbonate, Lexan®. This allows them to irradiate the product twice for ultimate sterility guarantees. The needles are again made from the titanium alloyed stainless steel. They use a triple needle lock system to ensure no needles can fall out; this comprises friction fits, medical glue and four rivets to hold the disks together. To test this claim they use a 10kg pull test on random samples which is an industry first.

Interestingly the handles of both devices (home and professional use) have a design-protected finger guard to protect the practitioner against accidental needle sticking. Following market research amongst Dermatologists, Pangaea found this to be a problem, so the guard, which is unobtrusive, effectively prevents practitioners from accidentally pricking themselves with the micro-needles. It has also been designed so that it can easily be put down on a clinical work surface without the needles touching anything. This preserves cleanliness and also prevents any deforming of the needles during the treatment session.

Pangaea announced that by the second quarter of 2013 all rollers they sell will be the new CE marked Skinrölla® product. Prices are not available until launch. www.medik8.co.uk/roller/stamp-intro.html

MTS Roller™ The Microneedle Therapy System or MTS Roller™ was introduced in 2004 by an American based company called Clinical Resolution Laboratory and is distributed in the UK by Medical Aesthetic Group.

The rollers are not CE marked.

The MTS Rollers are equipped with 200 needles (ground in Germany) mounted along a 21.5mm wide roller with 8 needles per horizontal row.

The barrel is made from Lexan®. Needles lengths are available in 0.2mm and 0.3mm for personal use and 0.5mm for clinical use and 1mm, 1.5mm and 2.0mm for medical use.

MTS Rollers are sterilized with gamma radiation and sealed in a hermetic pouch and are guaranteed to be 100% contaminant-free upon delivery.

Supply of the full range is available to medical professionals, with those of 0.5mm and under available also to trained therapists. Expect to pay up to £40 per roller. www.microneedle.com

Conclusion Well done for sticking with this lengthy article! The subject of medical skin needling rollers, before you even touch on treatment protocols, evidence of effectiveness in terms of collagen induction from various needle lengths, along with their ability to target and treat various indications including those quoted such as acne scarring, stretch marks and hair loss, is indeed a confusing and complex one.

The UK market provides a broad range of products to the aesthetic clinician, all with varying degrees of unique claims and presentation. Trusted brands who can demonstrate quality and safety to you when asked and who provide appropriate and adequate levels of training and support should always be favoured over those with vague or unsubstantiated claims.

The myriad of different types and brands of rollers now available from China and India is mind boggling. One doesn’t have to go far on the Internet to find companies who will ship devices over here for professional use, as well as the eye watering amount of shapes, sizes and configurations being sold direct to the public on sites such as eBay which no doubt have caused more harm than good to date. (This could fill another reference book!)

One website from China, which shocked me, illustrates the sheer range of products being manufactured by the Chinese and shipped worldwide due to the current inadequacies in the global regulation of these devices. You think we have a problem with too many CE marked Chinese dermal fillers entering Europe – then take a look at this, single, distributor based in China selling micro-needling devices from only $7 each! I would urge all aesthetic practitioners to steer clear of such cheap imports if you want to keep both your clients and your reputation.

Maybe it should fall to the medical aesthetic professionals in the UK to put together a code for the best practice of medical micro-needling treatments, including the preferred safety proven devices? Or maybe more lobbying needs to be done towards the MHRA to make skin needling rollers require a CE mark before sale. Who knows...British Association of Micro-Needling anyone?

Lorna Jackson Lorna has been Editor of The Consulting Room™, the UK’s largest aesthetic information website, for over nine years. She has become an industry commentator on a number of different areas related to the aesthetic industry, collating and evaluating statistics and writing feature articles, blogs, newsletters and reports for The Consulting Room™ and various consumer and trade publications, including Aesthetic Medicine, Cosmetic News and Aesthetic Dentistry Today.

I would like to thank Roger Bloxham, Managing Director and Georgina Farquhar, Marketing Executive from Aestheticare Ltd, Elliot Isaacs, Medical Director at Pangaea Laboratories Ltd and Jim O’Mahony, CEO of Boston Medical Group Ltd for their assistance with the more technical aspects of this feature article.

Food For Thought Patient Claims HA Filler Caused Stroke The Consulting Room™ was recently approached by a lady, posting a review on the site, who suffered a stroke the day after treatment with a hyaluronic acid filler. Naturally, this sounded like shocking news so we wanted to find out more...

There was nothing unusual about the treatment area, with product being administered to the mental crease and glabellar lines, (previously treated with botulinum toxin the month before). Neither was there anything unusual about the practitioner, in this case a nurse operating from a London clinic, thus a medical professional and not a non-medic or beauty therapist.

Yet, within 30 hours of treatment, the lady was treated in hospital for symptoms that appeared to be an allergic reaction (she complained of a swollen tongue and swallowing difficulties). She was treated accordingly but on further investigation was found to have suffered a stroke (with no evidence of allergic reaction). Her condition deteriorated a week later, which led to cardiac resuscitation and time on life support in a coma. Although recovering, she continues to suffer with fatigue, partial paralysis and vision problems.

So what is the background of the lady concerned? Well she told us that she was 35 years old, had no pre-existing health concerns before treatment, was a picture of health, being a certified Pilates instructor and avid yoga fan.

She had never smoked, rarely drank alcohol and was a vegetarian for most of her adult life. She had started getting Botox® and Dysport® injections from the age of 27-28 in her native America, and then at around 30 started on dermal fillers with injections of Juvéderm®, followed by Restylane® at a later date. On this occasion she was treated with Belotero®. Such a patient profile would normally trigger no alarm bells for a practitioner.

The patient was very open and happy to discuss her situation in the hope that lessons could be learned from her experience.

The treating practitioner followed the appropriate procedures for reporting a suspected adverse event and the manufacturer initiated an investigation according to global regulatory requirements to evaluate information from the patient, injector and treating clinicians to try to understand any relationship between the use of the product and the event.

Whilst intravascular injection of an HA filler can happen and there are documented serious adverse events there are no published case reports or peer reviewed studies where a causal link with stroke has been established. An understanding of vascular anatomy shows that for a stroke to occur the implant would have to travel via the venous system, through the capillaries in the lungs, through the heart and into the brain. This, coupled with the absence of published data, means that causality in this case cannot be established.

A further insight showed that the patient had her filler treatment within a week of returning from extensive long-haul travel in Europe and North America. One possible, but again, unproven link may relate to this extensive and recent air travel. Increased risk of Deep Vein Thrombosis (DVT) is a well-established consequence of prolonged air travel and a 2007 study published in The Lancet (Sorensen et al) followed a substantial population cohort and showed that in patients in whom a DVT occurred the risk of stroke was doubled in the first year post-DVT. Given the quantity of travelling in the weeks preceding her filler treatment, plus the likely disruption to an otherwise fit and exercise-filled lifestyle, the likelihood of an undetected DVT and its consequential elevated risk of stroke cannot be ruled out.

What lessons can be learned from this story? The key point may lie in a robust consultation process, in terms of analysing a potential patient’s lifestyle and the things they have done in the weeks and months leading up to treatment which could have an impact on perceived treatment outcomes or their underlying health profile. As more light is shone on the aesthetics industry in the wake of the PIP breast implant furore it may be worth practitioners ensuring that their informed consent process is rigorous and that their insurance cover is appropriate.

Further lessons may lie in there being no substitute for good facial anatomy knowledge and the use of products which have the benefit of robust safety evaluation (FDA approval as well as CE marking) and the backing of a manufacturer who has well established adverse event management and medical information capability. The aesthetics industry deserves to continue to grow but can only do so if patient safety remains at the forefront of priorities.

Eye Spy With My Industry Eye Aesthetic Awards 2012/2013 The cream of the aesthetics industry crop donned their glad rags to celebrate the annual Aesthetic Awards in association with Cosmetic News magazine. The Moulin Rouge themed event, took place at The Grand Connaught Rooms in London’s Covent Garden on December 1st and was a huge success with more than 400 people joining together to celebrate the success stories of the industry.

The 30 awards categories were designed to acknowledge those who have gone that extra mile over the last year, from clinics and individual practitioners to manufacturers and suppliers, as well as the leading products and treatments shaping the market. After receiving thousands of entries and nominations, the awards team had the difficult task of whittling down the entries to create the final shortlist.

Mystery shoppers travelled up and down the country to visit the clinics shortlisted in the Clinic of the Year and categories and the votes came flooding in via the Cosmetic News website. Cosmetic News readers including the top doctors, nurses, dentists, surgeons and dermatologists in the country voted for the products and procedures they most rated. For the first time this year a panel of expert judges were also recruited to give their feedback on the shortlisted products, their scores, combined with the votes gave the final winners. The short lists were announced in October so it has been a nail-biting wait for those who made the final cut - but finally the night had arrived.

The evening’s compere was Martyn Roe from The Consulting Room and the event was sponsored by Harley Street Beauty, Syneron Candela and Kelo-cote.

Here is a rundown of who the winners were…

Best Product Innovation Lustre (Ambicare Health) Best Newcomer (Product or Treatment) Restylane® Lip Refresh (Q-Med/Galderma) Judges Choice Award for Innovation in Technology Syneron Candela Cosmeceutical of the Year SkinCeuticals (L’Oreal) Injectable Product of the Year Juvederm Voluma (Allergan) Treatment of the Year (Face) Genuine Dermaroller (AesthetiCare) Treatment of the Year (Body) Soprano Pain Free Hair Removal (ABC Lasers) Best Selling Retail Product Obagi Blue Peel Radiance Equipment Brand of the Year ABC Lasers Best Weight Loss/Diet Programme/Product Alizonne Sales Representative of the Year Frank Ward – Galderma

Best Customer Service by a Manufacturer/Supplier Merz Aesthetics Best Advertising Campaign by a Manufacturer/Supplier Allergan – Quality is Key Campaign Distributor of the Year Healthxchange Services to the Industry Emma Davies Rising Star Dr Natalie Blakely Best Clinic Chain (Sponsored by AesthetiCare) Court House Clinics Best New Clinic London Bridge Plastic Surgery (LBPS), Wimpole Street, London Best Clinic (four rooms or more) Face etc Medi-Spa, York Best Clinic (three rooms or less) European Dermatology, London Best Cosmetic Dental Clinic Tracey Bell Clinics, Liverpool/Isle of Man

Best Mobile Practitioner Karen Lockett Aesthetic Nurse Practitioner of the Year Emma Davies Aesthetic Practitioner of the Year (Sponsored by The Consulting Room) Dr Robin Stones Cosmetic Dentist of the Year Dr Emma Ravichandran, Clinetix, Glasgow Best Clinic Customer Service Skin Associates, Wimpole Street, London Best Clinic Website Destination Skin, www.destinationskin.com Speaker of the Year Dr Raj Acquilla Clinic Receptionist of the Year Jasmin Byrne, EF Medi-Spa, Kensington Association of the Year British Association of Cosmetic Nurses (BACN) Lifetime Achievement Award (Sponsored

by SkinCeuticals) Mr Chris Inglefield

To register you interest in the product please click here and fill in the form or contact us directly by clicking here.

Business Corner Harley Medical Group ‘Changes Hands’ Administrators have confirmed that the Harley Medical Centre Ltd, incorporated on 2nd June 1983 and traded as a cosmetic surgery business also providing non- surgical cosmetic treatments under the th name The Harley Medical Group went into administration on 9 November 2012. th

For the year to 30 June 2011, the company's filed accounts reported a loss of £446,542 after tax on a tumover of £26.187m, with a net asset position of £2.646m. The company fitted approximately 13,100 PIP implants, now known to be faulty, supplying more than any other private cosmetic surgery firm in the UK. The sale of the company's business and assets to Aesthetic and Cosmetic Surgery Limited, ACS, incorporated on th th 13 September 2012 was completed on 10 November 2012. The purchaser, ACS, is therefore now deemed a connected party as defined by Section 249 of the Insolvency Act 1986 by way of common directors in Mel Braham, Louise Guillot and Pierre Guillot who retain a minority shareholding.

The consideration for the company's business and assets was £150,000, on completion with an Additional Consideration of £80,000, as detailed below. The company's business and assets sold include:           

the business Intellectual Property the customer list the equipment the acquired debts the goodwill the trading names the information technology all business premises relating to the Company the benefit of the potential insurance claims against the manufacturer the stock the work in progress

The consideration was agreed as follows:  

the sum of £150,000 payable on the date of completion and the Additional Consideration

The Additional Consideration is payable on completion of the assignment of the leases of the premises to the purchaser as follows:  

the sum of £4,000 upon completion of the first assignment to the Purchaser; and the further sum of £4,000 upon completion of each assignment of each lease until such time as the purchaser has paid the Additional Consideration in full.

In addition, it was agreed to allow the balance of any retained funds held by Barclays to be released and transferred to ACS to facilitate the completion of the contracts. The purchaser also took on employee TUPE liabilities of approximately £170,000.

ACS also agreed to: 



provide all treatments purchased by patients but not delivered at the date of completion. The value of such treatments at the date of completion was £3,384,424. As part of this exercise, the purchaser is agreeing to assume liabilities of the company to Barclays in relation to chargebacks with a potential exposure of £2million. provide on-going PIP aftercare where patients can prove there is a medical need for implant removal.



assist with on-going matters in respect of PIP claims.

After taking all the above factors into consideration, the administrators are of the opinion that the sale has provided the best possible outcome for creditors as a whole. Had a sale not been concluded, the business would have collapsed with significant additional liabilities and no prospect of a return for creditors.

Assets excluded from the sale include office fumiture and equipment over which HMRC have levied distraint. It has been agreed that these assets will be held until an agreement has been reached with HMRC regarding the value of these assets.

Mel Braham, Louise Guillot and Pierre Guillot are involved in the management of ACS. The administrators are not aware that they have provided any guarantees to Barclays for any potential liability under their charge. They understand that Barclays are providing merchant services and current account banking facilities for ACS moving forward.

This sale is not part of a wider transaction. There are no options, buy-back arrangements or similar conditions attached to the contract of sale. No security has been obtained or was requested in respect of the deferred consideration.

A copy of the full letter to creditors can be seen by contacting ron@consultingroom.com.

Has The ‘Daily Deals’ Website Groupon Had Its Day? According to Forbes magazine shares in ‘daily deals’ site Groupon were trading down in November after they posted earnings for the third quarter of 2012 that missed analysts’ expectations.

Groupon posted a net income that was flat or zero, on revenue of $568.6 million when they were expect to earn more in sales. The company’s stock had already hit an all-time low earlier in the month so this added more concerns for the .com business. In explaining the earnings miss, Groupon cited weakness internationally, where revenue grew just 3% year-over-year, compared to 81% growth year-over-year in North America. North America growth was however driven by the new ‘Groupon Goods’, which is the sale of physical goods with Groupon as the merchant, unlike its traditional Groupons, which sell services for third-party merchants.

This coincides with news from Australia this month where doctors have called for medical regulators to crack down on daily deal websites, such as Groupon, that sell cut-price Botox® injections and liposuction, claiming the sites continue to breach local advertising rules, which ban such sales techniques for the medical procedures. The Cosmetic Physicians Society of Australia (opens PDF) has written to all major group buying websites warning them the deals flout Medical Board guidelines and Australian Health Practitioner Regulation Agency (AHPRA) legislation, which state such procedures must be not be advertised as limited time offers.

This follows similar adjudications from our own UK Advertising Standards Authority in relation to deals which flout laws governing the advertising of prescription only medicines, in this case, botulinum toxins to the public.

The initial attraction of ‘daily deal’ sites, both to consumers and clinics, in certainly waning as businesses realise that the excessive price reductions demanded by Groupon to even appear on the site require either a significant ‘loss leader’ approach to the transaction with the hope of ongoing, full-price client retention or up-selling, which with price sensitive individuals is highly unlikely, or a temptation to reduce product quantities or treatment session times to those who take up the offer in order to make it worthwhile financially, which again will not aid client retention.

Blogs covering ‘daily deal’ websites can be found at www.consultingroom.com/blog/tags/67/advertising.

Advertorial: Pensions Auto-enrolment – An Overview From 2012, changes to pensions law will affect all employers with at least one worker in the UK. This Fact sheet, provided by Citation plc and based on The Pensions Regulator’s document ‘Workplace Pensions Law is Changing’, is an overview of these changes, including what employers must do and how they might set about getting ready.

Citation plc is one of the UK’s largest Health & Safety and Employment Law firms, with over 6,500 UK businesses as clients. For further details call 0845 844 1111 or visit www.citation.co.uk/affinity/abs

Legislation Getting Ready for GP Revalidation - Presentation by the GMC The General Medical Council (GMC) recently ran a workshop entitled ‘Getting Ready for Revalidation’. A transcript and slide show of this is available for those with concerns or questions about the process.

Revalidation is part of a wider system of measures to promote improvements in safety and quality. It is intended to ensure all medical practice takes place within a governed environment and is a positive affirmation of a doctor’s professionalism based on GMC core guidance ‘Good Medical Practice’. Revalidation isn’t a test or exam with a pass or fail outcome, or a new way to raise concerns about a doctor.

The full slide show is available from www.slideshare.net/GMCUK/gmc-revalidation-workshop-at-agm-2012 More information can also be obtained from the NHS Revalidation Support Team website www.revalidationsupport.nhs.uk

Another New Association For The Industry!

Another new trade organisation has been launched, targeted at the aesthetic industry. The Association of Aesthetics, Injectables & Cosmetic Laser or AAIC is a not-for-profit organisation, who state that they ‘welcome professionals with both medical and non-medical background who agree to follow our code of covenant and have full accreditation and insurance’.

It aims to represent ALL those working in the aesthetic, injectables and cosmetic industry as they believe that a level playing field is needed and it does not exclude individuals. They state; “our aim is to bring together ALL Aesthetic Practitioners to share the vision for competency in training, standards, safety & inspection”.

It sets out its mission as: 

 



The AAIC is the only association where members have a yearly independent inspectorate with agreement to adhere to audit on the Botulinum & Dermal Fillers register.

To protect the general public with a ‘one prescription, one client’ treatment protocol with a Botulinum & Dermal Filler register.

The AAIC mission is to offer full transparency within the Aesthetics profession by championing a “Charter of Excellence” for training to National Occupational Standards Public safety as number one priority at all levels.

As you can imagine, many medical professionals and their representative bodies are watching the developments and actions of this new group very closely as they seem happy to support many of the other healthcare operatives (such as podiatrists and paramedics) and non-medics (including beauty therapists and hair dressers) now entering the facial aesthetic and cosmetic injectable marketplace. We will keep you updated of any news!

Book Review Get 20% Off* Books From Informa Healthcare With The Consulting Room™!

This month's book offer:

Illustrated Manual of Injectable Fillers: A Technical Guide to the Volumetric Approach to Whole Body Rejuvenation, First Edition Edited By: Neil Sadick (Sadick Aesthetic Surgery & Dermatology, New York, NY, USA) Paul J. Carniol (Cosmetic Laser & Plastic Surgery, Summit, NJ, USA) Deborshi Roy (Facial Plastic Surgery, at Sadick Aesthetic Surgery and Dermatology) Luitgard Wiest (Private practice, Munich, Germany)

This highly illustrated book is a refreshingly straightforward guide on how to select and use the right filler for a particular patient. It discusses the limitations and potential complications involved in using fillers, helping you to achieve safe, reliable, aesthetic results and details the newer options available in European markets, keeping you at the cutting-edge of your field.

Table of Contents Part I

Introduction Chapter 1: Introduction to volumetric rejuvenation Chapter 2: Overview of injectable fillers Chapter 3: Approach to choosing the ideal filler

Part II

Upper Facial Rejuvenation Chapter 4: Anatomy of the brow and periorbital region Chapter 5: Volumetric approach to periorbital rejuvenation

Part III

Midfacial Rejuvenation Chapter 6: Anatomy of the midface Chapter 7: Volumetric approach to midfacial rejuvenation

Part IV

Lower Facial Rejuvenation Chapter 8: Anatomy of the lower face and neck Chapter 9: Volumetric approach to lower facial rejuvenation Chapter 10: Volumetric approach to the lips

Part V

Other Anatomical Sites Chapter 11: Volumetric approach to rejuvenation of the hands Chapter 12: Volumetric approach to rejuvenation of the buttocks Chapter 13: Post liposuction defects

Part VI

Emerging Products Chapter 14: US Experience Chapter 15: European Experience

Hardback Published: May 2011, ISBN: 9780415476447, 288 pages, 200 colour illustrations.

Discounted Price: £92 / €114 (Normal Price: £115 / €143) Don’t miss out! Special 20% Discount for Consulting Room members and Free Shipping!

To order call +44 (0)20 7017 5540 quoting promo code GOCGOLD, or use the order form www.consultingroom.com/Storage/CA_Legislation/PDF/Informa_ConsultingRoom_orderform.pdf Enquiries should be sent to Gerard.OBrien@informa.com. For more information and a full catalogue of available titles at this great 20% discount offer, please click here - www.consultingroom.com/MembersArea/Services/Services_Display.asp?CA_Services_ID=22&CA_Services_Category_ID=11. *Terms & Conditions Apply

Educational Opportunities

Training, Events, Mentoring etc...

Ensure that you are kept up to date with all educational opportunities, including webinars, seminars and conferences. www.cosmetictraining.co.uk is a focused directory that brings together key training opportunities and events. The dedicated and unique reference site will provide information about all areas of the Aesthetic business:

Cosmetic Training Features:      

Conferences & Meetings Bespoke Training and Mentoring Cosmetic Industry Qualifications Training Venues for Hire Training Courses & Webinars Business Related Seminars

With over 40,000 Procedures performed in Britain in 2010 we are constantly seeing emerging trends, new innovations, new products and new procedures. Therefore it’s important for you and your staff to keep constantly updated on all the changes in this fast paced business.

Receive a FREE monthly email update on the upcoming and latest events and opportunities.

For those members who offer training/mentoring or rooms for hire we also offer a range of competitively priced advertising options - including listing of training courses in our directory, targeted banner advertising in our training search results pages and opportunities to sponsor our monthly training update e-newsletter. Click on the image to learn more.

www.cosmetictraining.co.uk

Conferences Dates For Your Diary FACE Conference 2013 SAVE THE DATE! FACE 2013, the UK’s premier medical aesthetic conference and exhibition is moving to a larger venue in 2013 to help accommodate the growing lecture programmes. For more information as the agendas unfold, please visit: www.faceconference.com 21st – 23rd June 2013 at the QEII Conference Centre, Westminster London

For details of all upcoming UK and Non-UK conferences and exhibitions please visit our Cosmetic Training website.

Give Your Aesthetic Business a Competitive Edge & Attend

Practical Business Strategies & Product Ideas to Increase Your Profits in 2013 The Consulting Room™ are again hosting several special SMART Ideas events during 2013, in conjunction with the world’s largest laser and radiofrequency device manufacturer - Syneron Candela, and cosmetic injectables manufacturer – Merz Aesthetics.

Provisional dates for 2013 include:

Saturday 26th January in Manchester Saturday 27th April in London The SMART Ideas format provides an opportunity for you to explore the very latest product innovations, alongside reviewing core business principles related to running an aesthetic clinic.

SMART ideas provides an informal and friendly opportunity for you to explore unique new products, have personal demonstrations, discuss your business model and have a free web evaluation with our professional web designer all in one day! A range of industry exhibitors will also be attending the events.

Delegates attending these unique seminars will learn the very latest information related to practical use of cosmetic injectables for total facial contouring; lasers and RF devices for hair removal and skin rejuvenation; topical skin lightening treatments; and web marketing and business development techniques.

For more information, please visit www.smartseminar.co.uk.egister your interest please call Danny Large on 01788 577 254 or visit www.smartseminar.co.uk/Register/

O Ovveerr 55,,550000 cclliinniiccaall aabbssttrraaccttss iinn oouurr M Meem mbbeerrss A r e Areaa!!

Clinical Information

Juvéderm(®) Volbella™ in the perioral area: a 12-month prospective, multicenter, open-label study.

Eccleston D, Murphy DK. Private Practice, Birmingham, UK. Clin Cosmet Investig Dermatol. 2012;5:167-72.

BACKGROUND: Hyaluronic acid dermal fillers are frequently used for lip augmentation, and a new filler has been developed with characteristics especially suited for the lips.

METHODS: Four European sites treated 60 subjects with Juvéderm(®) Volbella™ injectable gel in the perioral area, and subjects returned to the clinic at 1, 3, 6, 9, and 12 months for follow-up. The primary effectiveness endpoint established a priori was a Month 3 responder rate on the 4-point Lip Fullness Scale (LFS) of ≥40% and statistically > 0%, where responders improved ≥ 1 point from baseline on the investigator's assessment of LFS. At follow-up, subjects assessed lip fullness goal achievement, the look and feel of their lips, and their satisfaction with the effects of treatment.

RESULTS: The Month 3 LFS responder rate was 93.2% (P < 0.0001), so the primary endpoint was met, and clinical effectiveness was demonstrated. The responder rate over time showed that 78.0% of subjects still had improved lip fullness at Month 9 and 48.3% at Month 12. After treatment 98.3% of subjects reported that their lip fullness goal had been achieved, and this was maintained at 86.4% at Month 9 and 56.9% at Month 12. At Month 1, 81.0% of subjects reported that their lips felt smooth, and 91.4% reported that their lips looked natural (scores of 7-10 on an 11-point scale, where 0 was an unfavorable outcome and 10 was a favorable outcome). Similarly, 96.6% of subjects reported being satisfied (scores between 7 and 10 on an 11-point scale where 0 = very dissatisfied, 10 = very satisfied) at Month 1, and by Month 12 more than 80% of subjects were still satisfied. There were no severe adverse events related to treatment.

CONCLUSION: Juvéderm(®) Volbella™ injectable gel is well tolerated and has been demonstrated to provide a smooth and natural improvement in lip fullness that lasts for up to 1 year.

The Optimal Filler: Immediate and Long-Term Results With Emulsified Silicone (1,000 centistokes) With Cross-Linked Hyaluronic Acid.

Fulton J, Caperton C. J Drugs Dermatol. 2012 Nov 1;11(11):1336-41.

Background: Silicone is one of the oldest and longest lasting of the dermal fillers. Microdroplet silicone injections have proven to be safe and effective. This paper describes how to obtain microdroplet silicone (1,000 centistokes) in a consistent manner, including a discussion of its efficacy and safety.

Methods and Materials: A simple, permanent method of tissue augmentation is described. U.S. Food and Drug Administration- approved liquid silicone (Silikon®) is emulsified with cross-linked hyaluronic acid through a LuerLok to Luer-Lok connector between two 3-cc syringes. This stable emulsion is injected through a 27G needle or through a 25G or 27G microcannula into the middermis, subcutaneous tissue, or periosteum.

Results: The results of 95 cases are described. The emulsion is most beneficial for distensible acne valleys, nasolabial folds, glabellar frown lines, augmentation of the vermilion border of the lips, and projection of the nose, cheekbones, and chin. Exterior nasal deviations and soft tissue defects are also improved. Complications are minimal and include temporary bruising, erythema, and mild edema. Any temporary small nodules are easily leveled with massage. Occasionally, it takes a repeat session at 1 month to completely elevate depressions. The resulting elevations remain stable during the 2-year follow-up period. No silicone granulomas have developed.

Conclusions: This methodology has replaced many indications for temporary, semipermanent, or permanent fillers.

Brighter eyes: combined upper cheek and tear trough augmentation: a systematic approach utilizing two complementary hyaluronic Acid fillers.

Tung R, Ruiz de Luzuriaga AM, Park K, Sato M, Dubina M, Alam M. J Drugs Dermatol. 2012 Sep 1;11(9):1094-7.

Non-surgical rejuvenation of the periorbital-cheek complex can be effectively and safely accomplished using a combination of two hyaluronic acid (HA) fillers with distinct viscosities. We present a series of 21 patients with mild to moderate tear trough deformities who were treated with concomitant injection of two dermal fillers (RestylaneÂŽ and PerlaneÂŽ). Procedural technique entailed micro-depot injections of the finer viscosity HA into the sub-muscular plane along the orbital rim followed by manual massage. Secondly, injections of the thicker, more firm HA were placed in the sub-muscular and/or deep dermal spaces in the upper malar and lateral zygomatic areas and in the medial aspect of the temporal fossa. On average 0.5 mL Restylane and 0.5 mL Perlane were used per side.

Statistically significant improvement in modified Wrinkle Severity Rating Scale scores was seen at 20 weeks.

Overall improvement in modified Global Aesthetic Improvement Scale scores occurred in 20 out of 21 patients.

Mean patient satisfaction scores increased by 2 grades relative to baseline. Patients' self-reported overall mean improvement was 2.23, indicating moderate (26% to 50%) to good (51% to 75%) improvement. Side effects were limited to transient bruising and swelling. No patients required dissolution of injectant with hyaluronidase. Overall, this combination filler procedure was found to produce both statistically significant and clinically apparent improvement and was associated with an extremely high degree of patient satisfaction.

Case Reports of Adipose-derived Stem Cell Therapy for Nasal Skin Necrosis after Filler Injection.

Sung HM, Suh IS, Lee HB, Tak KS, Moon KM, Jung MS. Department of Plastic and Reconstructive Surgery, Kangnam Sacred Heart Hospital, Hallym University Medical Center, Seoul, Korea.

Arch Plast Surg. 2012 Jan;39(1):51-4.

With the gradual increase of cases using fillers, cases of patients treated by non-medical professionals or inexperienced physicians resulting in complications are also increasing. We herein report 2 patients who experienced acute complications after receiving filler injections and were successfully treated with adipose-derived stem cell (ADSCs) therapy. Case 1 was a 23-year-old female patient who received a filler (Restylane) injection in her forehead, glabella, and nose by a non-medical professional. The day after her injection, inflammation was observed with a 3Ă&#x2014;3 cm skin necrosis. Case 2 was a 30-year-old woman who received a filler injection of hyaluronic acid gel (Juvederm) on her nasal dorsum and tip at a private clinic. She developed erythema and swelling in the filler-injected area A solution containing ADSCs harvested from each patient's abdominal subcutaneous tissue was injected into the lesion at the subcutaneous and dermis levels. The wounds healed without additional treatment. With continuous follow-up, both patients experienced only fine linear scars 6 months postoperatively. By using adipose-derived stem cells, we successfully treated the acute complications of skin necrosis after the filler injection, resulting in much less scarring, and more satisfactory results were achieved not only in wound healing, but also in esthetics.

Photodynamic therapy for skin rejuvenation: review and summary of the literature - results of a consensus conference of an expert group for aesthetic photodynamic therapy.

Karrer S, Kohl E, Feise K, Hiepe-Wegener D, Lischner S, Philipp-Dormston W, Podda M, Prager W, Walker T, Szeimies RM. Department of Dermatology, University Clinic of Regensburg Rosenpark Clinic, Darmstadt Private office for dermatology, Hildesheim Group practice for dermatology, Kiel Dermatology Center Cologne Department of Dermatology, Darmstadt Hospital Dermatologikum Hamburg Private office for dermatology, Ludwigshafen Department of Dermatology and Allergology, Vest Clinic, Recklinghausen (all Germany).

J Dtsch Dermatol Ges. 2012 Nov 29.

Skin rejuvenating effects of photodynamic therapy (PDT) for photoaged skin has been well-documented in several clinical trials. Different photosensitizers (5-aminolevulinic acid, methyl aminolevulinate) and diverse light sources (light-emitting diodes, lasers, intense pulsed light) have been used with promising results. An improvement of lentigines, skin roughness, fine lines and sallow complexion has been achieved with PDT. These clinically evident effects are at least in part due to histologically proven increase of collagen and decrease of elastotic material in the dermis. Effective improvement of photoaged skin, simultaneous treatment and possibly also prevention of actinic keratoses, the possibility of repeated treatments and, in contrast to other procedures, limited and calculable side effects make PDT a promising procedure for skin rejuvenation.

Evidence-based review and assessment of botulinum neurotoxin for the treatment of secretory disorders.

Naumann M, Dressler D, Hallett M, Jankovic J, Schiavo G, Segal KR, Truong D. Department of Neurology & Clinical Neurophysiology, Academic Hospital of the Ludwigs-Maximilians-University Munich, Germany.

Toxicon. 2012 Nov 23. pii: S0041-0101(12)00787-8.

Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of certain hypersecretory disorders, including hyperhidrosis, sialorrhea, and chronic rhinorrhea, an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials. Evidence tables generated in the 2008 Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (AAN) review of the use of BoNT for autonomic disorders were also reviewed and updated. The panel evaluated evidence at several levels, supporting BoNT as a class, the serotypes BoNT-A and BoNT-B, as well as the four individual commercially available formulations: abobotulinumtoxinA (A/Abo), onabotulinumtoxinA (A/Ona), incobotulinumtoxinA (A/Inco), and rimabotulinumtoxinB (B/Rima). The panel ultimately made recommendations for each therapeutic indication, based upon the strength of clinical evidence and following the AAN classification scale.

For the treatment of axillary hyperhidrosis in a total of 923 patients, the evidence supported a Level A recommendation for BoNT-A, with a Level B recommendation for A/Abo and A/Ona and a Level U recommendation (insufficient data) for A/Inco and B/Rima. Five trials in 82 patients supported the use of BoNT in palmar hyperhidrosis, with a Level B recommendation for BoNT-A and a Level C recommendation for BoNT-B; individual formulations received a Level U rating due to insufficient data. BoNT (and all individual formulations) received a Level U recommendation for the treatment of gustatory sweating. Support for use of BoNT in sialorrhea was derived from eight trials in a total of 222 adults and children. Evidence supported a Level B recommendation for A/Abo, A/Ona, and B/Rima and a Level U recommendation for A/Inco. Evidence supported a Level B recommendation for A/Ona for the treatment of allergic rhinitis, based on two Class II studies in 73 patients. A lack of published studies for A/Abo, A/Inco, or B/Rima supported a Level U recommendation for those formulations.

Further clarity on the optimal mode of administration and additional studies using other BoNT formulations are needed to fill current evidence gaps.

Treatment errors resulting from use of lasers and IPL by medical laypersons: results of a nationwide survey.

Hammes S, Karsai S, Metelmann HR, Pohl L, Kaiser K, Park BH, Raulin C. Laser Clinic Karlsruhe, Department of Dermatology, Heidelberg University Hospital, Department of Dermatology, Darmstadt Hospital, Department of Dermatology, Greifswald University Hospital, Department of Oral and Maxillofacial Surgery/Plastic Surgery, Greifswald University Hospital, (All in Germany).

J Dtsch Dermatol Ges. 2012 Nov 29.

Background: The demand for hair and tattoo removal with laser and IPL technology (intense pulsed light technology) is continually increasing. Nowadays these treatments are often carried out by medical laypersons without medical supervision in franchise companies, wellness facilities, cosmetic institutes and hair or tattoo studios. This is the first survey is to document and discuss this issue and its effects on public health.

Patients and methods: Fifty patients affected by treatment errors caused by medical laypersons with laser and IPL applications were evaluated in this retrospective study. We used a standardized questionnaire with accompanying photographic documentation. Among the reports there were some missing or no longer traceable parameters, which is why 7 cases could not be evaluated.

Results: The following complications occurred, with possible multiple answers: 81.4% pigmentation changes, 25.6% scars, 14% textural changes and 4.6% incorrect information. The sources of error (multiple answers possible) were the following: 62.8% excessively high energy, 39.5% wrong device for the indication, 20.9% treatment of patients with darker skin or marked tanning, 7% no cooling, and 4.6% incorrect information.

Conclusions: The causes of malpractice suggest insufficient training, inadequate diagnostic abilities, and promising unrealistic results. Direct supervision by a medical specialist, comprehensive experience in laser therapy, and compliance with quality guidelines are prerequisites for safe laser and IPL treatments. Legal measures to make such changes mandatory are urgently needed.

SOURCE: PubMed

Interesting News Articles You May Have Missed Due to global copyright laws the Consulting Room™ is unable to reproduce entire news articles; therefore we provide an abstract and a link to the original news article. Although every effort is made to ensure that these links continue to function, there are occas ions when third party websites will remove or archive the news article, leading to a broken link. We apologise if you find such a problem, and woul d appreciate it if you would inform us by emailing admin@consultingroom.com so we can make every attempt to remedy it.

Commonly Prescribed Glaucoma Drug May Be Effective In Treating Male Pattern Baldness And Other Forms Of Alopecia A new research report appearing online in The FASEB Journal shows how the FDA-approved glaucoma drug, bimatoprost, causes human hair to regrow. It`s been commercially available as a way to lengthen eyelashes, but these data are the first to show that it can actually grow human hair from the scalp.

SOURCE: Medical News Today

Allergan Considers Lap-Band Unit Sale as Demand Declines Allergan Inc., the maker of the Botox wrinkle treatment, may sell its obesity business, including the Lap-Band weight loss device, as revenue declines and questions mount about the risk of the procedure.

Revenue for the obesity intervention unit will be about $160 million in 2012, the Irvine, California-based company said in a statement yesterday. Sales fell from $203.1 million last year and a peak of $296 million in 2008, the company reported.

SOURCE: Bloomberg

Fight illegal bleachers Government and Trading Standards must step up and deal with the illegal practice of teeth whitening following the new European Directive.

It is feared emphasis will focus on where the non-registrants obtained the product, rather than the fact it is being used and compromising patient safety.

SOURCE: Dentistry.co.uk

Why are so many girls in their 20s hooked on Botox?

Especially as experts warn it will probably make them look OLDER. When Geniene Reese and her friends went en masse to make inquiries about having Botox injections, the consultant, based at a reputable clinic in Liverpool, assured the group it was better to ‘start young’.

SOURCE: Daily Mail

Gender-specific differences matter when marketing aesthetic services to men Botulinum toxin treatments in men is a rapidly expanding market, but success in serving this growing population requires physicians to hone gender-specific approaches, according to Michael Eidelman, M.D. Speaking at the 2012 annual meeting of the American Society for Dermatologic Surgery.

SOURCE: Modern Medicine

Allergan to Pay $350 Million for SkinMedica Business Allergan Inc., the Botox maker weighing the sale of its obesity unit, will expand the range of its skin care products by agreeing to purchase a unit from SkinMedica Inc. for $350 million. SkinMedicaâ&#x20AC;&#x2122;s products include a prescription treatment for reducing female facial hair and lotions to reduce the appearance of wrinkles.

SOURCE: Bloomberg

Faulty breast implant firm plunges into bankruptcy... to avoid paying millions to 1,700 victims Thousands of British women fitted with faulty breast implants face further agony after a clinic at the centre of the scandal deliberately went into administration to avoid a possible multi-million-pound legal payout. The Harley Medical Centre faced legal claims from 1,700 women who suffered pain and distress after being fitted with defective PIP implants. But last week, the cosmetic surgery chain appointed administrators after its management complained that legal action could put the firm out of business.

SOURCE: Daily Mail

Web info on `designer vagina` procedures poor and often inaccurate The quality of internet information available for women opting for `designer vagina` procedures is `poor`, and in some cases, inaccurate, reveals a small study led by academics at the UCL Institute of Women`s Health.

SOURCE: Medical Xpress

Surgeons claim reality TV glamorises cosmetic surgery Top surgeons say they think some reality TV programmes glamorise cosmetic surgery. Rajiv Grover, president of the British Association of Aesthetic Plastic Surgeons (Baaps), said: "People are forgetting it's a medical operation.

"The way that The Only Way is Essex perhaps portrays it is as if it's a beauty treatment that's common."

SOURCE: BBC Newsbeat

Acne drug Roaccutane 'overused' says UK dermatologist An acne drug, which it is claimed is linked to depression, is being given to a growing number of young people who don't need it, says one of the UK's top dermatologists. Roaccutane is the most powerful drug to treat acne and has been prescribed to more than half a million people. Campaigners say it is dangerous and can cause serious mental health problems.

SOURCE: BBC Newsbeat

Cosmetic surgery millionaire Mel Braham owned secret offshore firm Head of UK's biggest cosmetic surgery chain, Harley Medical Group, initially denied any links with company in British Virgin Islands. The millionaire head of a controversial cosmetic surgery chain, the biggest in the UK, owned a secret offshore company linked to the clinic, it can be revealed.

SOURCE: The Guardian

Advertisement ABC Cryo Premium The most powerful cooling system on the market The revolutionary cryogenic skin cooling device from ABC Lasers hygienically cools the epidermis, before and after treatment, and dramatically reduces pain for a wide range of aesthetic treatments including IPL, Laser Tattoo Removal, Botox®, Injections, Fractional CO2 Laser therapy, Skin Resurfacing and more ablative IPL procedures.      

Lightweight and flexible hose to ensure regulated airflow 20% more cooling airflow power than the current leading system, the Zimmer Cryo 6 and costs around £1,000 less Customisable intensity controlled via a start/stop button Clear digital readout Temperatures of minus 32 degrees Longer manufactures guarantee of 3 years

For more information see ABC Lasers’ website at www.abclasers.co.uk

Great Member Special Offer Receive a Free Pair of NoIR LaserShields® IPL Shade 3 Style 35 Goggles when you buy Yamamoto Patient Eye Safety Guards. *** OFFER EXTENDED! *** This great offer is only available to Consulting Room members.

The Yamamoto YL-800w safety eye guard provides high quality protection for your patients eyes when using IPL/Lasers/Radiofrequency and Microdermabrasion.

Suitable for combined Radiofrequency/Laser/IPL devices as they do not conduct any electrical current.    

Colour of eyecup: white Detachable and adjustable rubber strap Comes with nose bridge size medium (can be interchanged with small and extra large bridges included for tailored patient comfort) Softcase included

Purchase these superb Yamamoto patient eye safety guards for only £105.75 (inc. VAT) – that’s a saving of £17.63 on non-member prices already - and receive the NoIR IPL Shade 3, Style 35 goggles (worth up to £52.88) absolutely free!

Take advantage of this great offer!

For more information on the products and to discuss this and other great laser/IPL eye protection deals, call us on 01788 577254.

Equipment Sales SaveOnKit pride themselves on excellent customer service. They stock a large inventory of high quality medical, dental and beauty equipment at vastly reduced prices. They are very pleased to offer a high quality service for all your equipment needs. All orders are processed quickly and sent to UK addresses free of charge; they will ship worldwide.

Below are the various devices that they currently have for sale.

Lutronic Mosaic non-ablative Fractional Laser Er:Glass skin-resurfacing System In good condition and full working order For Sale at £14,000 + VAT *PRICE REDUCED £13,300 + VAT* More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=506 Chromogenex NLite V Pulsed Dye Laser Hair removal Rejuvenation System In good condition and full working order For Sale at £3,800 + VAT More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=458 Lynton Lumina IPL Laser Hair Removal + YAG Skin Rejuvenation Acne Beauty System In very good condition and full working order For Sale at £9,500 + VAT More info - www.consultingroom.com/services/equipment-display.asp?equipment_id=651 Depilex Dermapeel Professional Microdermabrasion System In good condition, full working order For Sale at £912 *PRICE REDUCED AGAIN £570 + VAT* More info – www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=537 RVB active 7 touch beauty machine facial toning professional System This unit has had very minimal use and the condition reflects this some items are new in original packaging For Sale at £475 More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=599 Yperion L900 SR PSR002012 beauty treatment head Brand new, in original box. For use with L900 Hair removal and photolifting beauty machine.

For Sale at £912 *PRICE REDUCED £760* More info – www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=539 Eporex K69 Mesotherapy Cellulite Fat Reduction and Skin Rejuvenation System In good condition and full working order, costs £20,000 brand new For Sale at £8,400 + VAT *PRICE REDUCED AGAIN £3,166 + VAT* More Info - http://www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=446 E Light IPL Laser Hair removal Rejuvenation Wrinkle Vascular salon beauty System For Sale at £3,800 + VAT More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=496 Cosmopro Eye-O-Matic facial restore & skin rejuvenation Full working order. Helps restore and rejuvenate the face and delicate eye contour maximising product absorbency.

For Sale at £285 + VAT More info – www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=598 Nemectron Noblesse for Face and Body Facelift Wrinkles In good condition and full working order For Sale at £1,500 + VAT *PRICE REDUCED AGAIN £950 + VAT* More info - http://www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=437 Beauty Scope BS-888 Skin and Hair Analyser Intelligent skin/sebum/moisture/pigment diagnosis system For Sale at £300 + VAT *PRICE REDUCED £237.50 + VAT* More info - http://www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=438

Over line Xilia Stim 8 Face + Body Skin tightening System In good working order complete with attachments, cables, user manual and stand.

For Sale at £1,400 + VAT *PRICE REDUCED AGAIN £1187 + VAT* More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=434 Nemectron Nembrasion Professional Microdermabrasion System In good condition and full working order For Sale at £1,425 + VAT More Info - http://www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=439 Smart Peel Microdermabrasion with LED Light Therapy professional system In good working order complete with attachments For Sale at £2, 280 *PRICE REDUCED £1,425 + VAT* More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=535 Caci Future-Tec Skin Rejuvenation Beauty Machine In good working order complete with attachments - Vaculase, Microlase, Actuator attachments & foot pedal For Sale at £1,700 + VAT More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=367 Bio –Therapeutic L.A. Smile Teeth whitening system Cost £12,600 new in 2006. Current model, in good condition, had very little use.

For Sale at £3,000 + VAT *PRICE REDUCED £1,900 + VAT* More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=325 Biotec Bioskin LAS Skin Resurfacing Microdermabrasion System Bioskin Las Technology utilises a unique two-element approach to activate skin regeneration.

For Sale at £1,425 + VAT More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=344 Nora Bode OxyJet Star Oxyaroma Oxyspray facial and body treatment salon machine In very good condition, had had low usage and in full working order For Sale at £7,500 +VAT *PRICE REDUCED £6,175 + VAT* More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=516 Pollogen ReGen Tripollar Radio Frequency skin body facial beauty machine salon Very good condition, full working order. Unit was removed from a small clinic which closed shortly after it opened For Sale at £8,000 +VAT *PRICE REDUCED £7,600 + VAT* More info - www.consultingroom.com/Services/Equipment-Display.asp?Equipment_ID=515 No+Vello IPL Laser Hair Removal & Skin Rejuvenation Treatments Beauty System In very good condition and full working order. Supplied new in 2010 For Sale at £6,650 + VAT More info - www.consultingroom.com/services/equipment-display.asp?equipment_id=638 Beau Visage Facial Skin Imaging Diagnosis Treatment Beauty Therapy System In very good condition and full working order For Sale at £3,800 + VAT More info - www.consultingroom.com/services/equipment-display.asp?equipment_id=640 CACI Flash 1 IPL Hair Removal & Skin Rejuvenation Acne Treatments Beauty System In good condition and in full working order For Sale at £4,000 + VAT More info - www.consultingroom.com/services/equipment-display.asp?equipment_id=649 New Meridian Lapex BCS Pro 2000P Liposuction Cellulite Fat Laser Beauty Machine New in original packaging. Supplied to a clinic which closed shortly after opening in Late 2011. Unit never used.

For Sale at £9,500 + VAT More info - www.consultingroom.com/services/equipment-display.asp?equipment_id=677 Biorem Skin Master Plus Multi-functional Ultrasonic Beauty Treatment Machine In good condition and full working order For Sale at £1,330 + VAT More info - www.consultingroom.com/services/equipment-display.asp?equipment_id=678

Classifieds FOR SALE Lynton LUMINA MF Available now 2009 model Multifunctional LUMINA MF. Including: 650 handpiece for permanent hair reduction on skin types 1 – 5 and skin rejuvenation through collagen stimulation.

585 handpiece for removal of skin blemishes, superficial benign pigmentation, superficial vascular lesions, active acne and skin tone rejuvenation Offer includes: 40,000 shot handpieces 12 Month Warranty 2x Protective eyewear Clinical training for 5 people at your premises CD of high resolution before and afters Consent Forms Pre and post procedure guidelines Patient Leaflets On-going clinical support & helpline Webpage Templates

Price: £20,000 plus VAT Contact: Rachel McInnes, 01477 536970

Lynton LUMINA Q system Available now a pre-owned 2009 model LUMINA Q system. Including: 650 handpiece for permanent hair reduction on skin types 1 – 5 and skin rejuvenation through collagen stimulation.

585 handpiece for removal of skin blemishes, superficial benign pigmentation, superficial vascular lesions, active acne and skin tone rejuvenation 1064 Nd:YAG Laser (delivered through articulated arm) for deep leg veins, skin tightening and hair removal in skin types 4-6 Q-Switched 1064nm & 532nm Laser for multi-colored powerful tattoo removal Comes with a touchscreen display that is easy to use, a patient database to hold 10,000 client records and built in safety parameters.

Offer includes: Protective eyewear Clinical training for 5 people at your premises CD of high resolution before and afters Consent Forms Pre and post procedure guidelines Patient Leaflets On-going clinical support & helpline Webpage Templates 6 fully trained engineers on the road 48 hour guaranteed call-out

Price: £42,000 Contact: Rachel McInnes, 01477 536970

Lynton LUMINETTE Q Available now pre-owned 2011 model LUMINETTE-Q Portable Q-Switched Nd:YAG Laser Tattoo Removal System with 1064nm & 532nm handpieces. Offer includes: Protective eyewear Clinical training for 5 people at your premises CD of high resolution before and afters Consent Forms Pre and post procedure guidelines Patient Leaflets On-going clinical support & helpline Webpage Templates 6 fully trained engineers on the road 48 hour guaranteed call-out Tattoo removal with Q-switched Nd:YAG (1064nm) and KTP (532nm) Laser for reduction of multicoloured professional, amateur or traumatic tattoos, and also the removal of benign pigmented lesions.

Price: £8,000 plus VAT Contact: Rachel McInnes, 01477 536970

Laser Tattoo Removal This is a Q switch Class 4 laser. There are 2 wavelengths 1064nm (black / blue tattoos) and 532nm (red / orange and brown tattoos). The frequency is 1 – 6 hz (pulses delivered per second) up to 10 nano-seconds pulse width 3mm diameter. It is 700 – 1000 Volts up to 800mj.

The machine comes with a training manual, customer information, safety glasses and goggles and is a little over a year old.

Price: £3,000 ono Contact: Gillian Thornton, 01423 887111, info@deepblueskin.com

Chromogenex NLite V Pulsed Dye Laser Rejuvenation System The machine is in full working order. Manufactured in 2004 and stored for 6 years so the machine has had relatively light use but does not come with any attachments Equipment Details

Price: £3,500 ONO Contact: Ben, 07788185977, benscott25@hotmail.com

Tri Pollar TriPollar Radio Frequency (RF) technology is an innovative, proprietary 3rd generation RF technology. TriPollar overcomes the limitations of previous mono-polar and bi-polar technologies. Simple to use and extremely efficient, TriPollar treatments deliver immediate visible body and facial contouring effects from the first treatment – and longlasting results without surgery or downtime.

Recently Serviced and updated in Israel

Price: £9900 Contact: Dr K Sarmand, 07941213114, kayvan@sarmad.net

FOR RENT Dental Treatment Rooms For Rent Treatment rooms for rent in lovely Victorian building in Cobham, Surrey.

Dental suite consisting of 2 very well equipped rooms available.

Luxury A-Dec chairs, x rays, cabinetry and lovely working environment.

Sterilizing room adjoining suite is included in rent.

You will have used of kitchen and toilet facilities.

Waiting area available.

There will be no manned reception and will need to take own bookings.

Car parking is available attached to property.

Would suit 1-2 dentists or single handed dentist who works alongside a hygienist.

Own list would be an advantage.

Price: Starting rents from ÂŁ125 per day.

Contact: Sanjiv Rikhi, 07931 544446, info@aromaden.co.uk

For a full list of second hand equipment sales, please see: www.consultingroom.com/services/equipment.asp

Advertisement S.A.F.E.â&#x201E;˘ System Surgical Smoke Evacuation The Smoke Evacuator vacuums the plume created by laser and electrocautery treatments such as hair removal, tattoo removal and erbium procedures and protects physicians and staff performing these operations.

The U.S. FDA approved and European CE marked SAFE System smoke evacuator is built to handle any type of surgical smoke. Costs are low to purchase and operate.

Application:

The removal and filtration of laser and surgical smoke

Used by:

Hospitals, Plastic Surgeons, Cosmetic Surgeons, and more

Economical:

Due to the real time filter life pressure gauge

Compact:

9" x 9" footprint, 14" high

Quiet:

Less than 52dBA, quieter than the competition

Filtration:

ULPA: 99.999+%@ 0.12 micron

Weight:

24 lbs.

Electrical:

100-120 VAC, 50/60 HZ 220-240 VAC, 50/60 HZ

Regulatory:

UL, CSA, CE

Tubing:

Vacuum Tubing 7/8" x 8'

www.facebook.com/TheConsultingRoom

www.twitter.com/consulting_room

For more information, please contact Martyn Roe on martyn@abs4u.co.uk or telephone 07734 101275

www.youtube.com/user/ConsultingRoom

Editorial Changing Regulatory Environment for Cell Therapies Vavelta is a suspension of human dermal fibroblasts manufactured by Intercytex Ltd. When it was first developed in the 2008 for use in aesthetic surgery, the Medicines and Healthcare products Regulatory Agency (MHRA) agreed with Intercytex that it wasn’t a medicinal product for these indications. It didn’t treat a disease or act by immunological, pharmacological or metabolic mechanism which are the requirements for a material to be designated a medicinal product and such medicinal products require a marketing license.

Although not requiring a license from the MHRA at the time, the product still had to be produced

by Good Manufacturing practice at a licensed facility and the oversight of this was carefully monitored by the UK’s Human Tissue Authority (HTA).

The regulatory situation in the rest of the EU member states concerning whether Cell Therapies were Medicinal Products or not was not clear and in order to provide a coherent regulatory system throughout the whole EU the Advanced Therapy Medicinal Product legislation was developed. This classified Vavelta as a “Tissue Engineered ATMP” as it was “administered to human beings with a view to regenerating, repairing or replacing a human tissue”.

As a Tissue Engineered ATMP, Vavelta will require a full marketing license from the European Medicines Agency (EMA) from December 30 th 2012.

This will take time for Intercytex to obtain and will involve the Company carrying out a series of clinical trials and other studies.

Until it is able to obtain a license, Intercytex will not be able to advertise, promote or market Vavelta.

It will however still be manufacturing the product under GMP for its own clinical studies.

There are provisions in the legislation for instances where a patient may have special clinical needs that cannot be met by licensed medicinal products and Vavelta could be provided under these circumstances where there is a bona fide unsolicited order and the product is formulated in accordance with the requirement of a Doctor registered in the UK and the product is for use by their individual patients on their direct personal responsibility. Vavelta could not be provided however, if an equivalent licensed product is available that could meet the patient’s needs.

For more information or to answer any questions, please contact Intercytex Ltd on 0161 606 7204 or visit www.intercytex.com