ESGURS: Setting up a mesh complications service

London Complex Mesh Team UCLH London (GB)

uclh.enquiries. uclh_lcmc@nhs.net

Clinical Lead: S. Elneil, Deputy Clinical Lead: T. Greenwell, Urologists: J. Ockrim, H. Gresty, Colorectal Surgeon: A. Obichere, Imaging: P. Aughwane, Service Manager: H. Rowbottom, H. Light, Senior Clinical Fellow: S. Palmieri, Post CCT Fellow: A. Khan and Advanced Nurse Practitioner: E. Kuria.

Synthetic pelvic mesh was used for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for decades and became increasingly popular from the 1990s when surgical kits with precut mesh and applicators were developed and launched.

The true number of women with pelvic mesh in situ or with mesh complications worldwide is unknown (IMMDS, 2020). In England, Hospital Episode Statistics (HES) data have given an indication of the scale of mesh insertions and removals in the National Health Service (NHS) (Gurol-Urganci I, 2018) (Keltie K, 2017). One study analysed the complication rates in 92,246 women who had a midurethral tape (retropubic- TVT or trans-obturator- TOT) inserted between April 2007 and March 2015. The proportion of patients who experienced any complication during their procedure or up to 5 years postoperatively was 9.8% and 5.9% of women required re-admission for treatment within 5 years. (Keltie K, 2017).

There has been growing international appreciation, debate, and scrutiny over complications relating to pelvic mesh such as bleeding, infection, organ perforation including extrusion into the urinary and colonic tracts, vaginal exposure, mobility problems, sexual dysfunction, and pain (Petri E, 2012). There are several notable class action lawsuits in various countries (Dyer, 2020) (Reuters, 2021). A number of reports have been issued including the FDA safety alerts in 2008 and 2011, the Medicine and Healthcare products Regulatory Agency (MHRA) review in 2014, the Scottish Mesh Review in 2017 and most recently the IMMDS review led by Baroness Cumberledge in 2020. The latter highlighted the need for specialised services to help women with mesh complications.

Fig. 1: Intra-operative view of vaginal exposure of TVTO

Specialist commissioning Concerns regarding the safety of pelvic mesh inserted for incontinence and prolapse has led to a high vigilance pause in insertions in the UK. NHS England has commissioned specialist mesh centres to meet the complex needs of women with mesh complications. Upon this advice, NHS England set up seven geographically distributed complex mesh centres in

Fig. 2: Mesh centres in England Fig. 4: Sagittal T2 MRI showing a normally positioned retropubic TVT mesh

England. The London Complex Mesh Centre (LCMC) launched in July 2021. A further two are due to start in 2022, with further units being set up in Scotland, Wales, and Northern Ireland.

Patient and public involvement Multi-disciplinary pathways of care were developed over a number of years with the input of multiple patient focus groups – all of whom had a predominance of mesh-injured women. Their input was key to developing a surgical service alongside the input of pain and psychology support to form an integral part of the pathway. Patient working groups have regular meetings with MDT teams to ensure that processes, pathways, and communications are regularly updated and stay in step with what patients want and need, and advocacy panels communicate with national patient support groups. Regular communication and meetings between the mesh centres ensures that the delivery of care is standardised and will be monitored nationally with annual meetings, audit, and publication enshrined within this process.

MDT working Mesh centres offer women a holistic care pathway involving an MDT of specialists with weekly meetings.

MDT teams include urologists, urogynaecologists, colorectal surgeons (where appropriate), radiologists, chronic pain medicine, psychology, anaesthesia, physiotherapy, and clinical nurse specialists. The surgeons within mesh services have specialist interests and training in complex female urogenital reconstruction. External referrers are invited to join MDTs once a month to present their cases and mesh centres work closely with other, NHS trusts to accept patient referrals.

Imaging Magnetic resonance imaging (MRI) and ultrasound (US) play a key role in the identification of mesh and characterisation of the type of mesh implant, position, and relationship with pelvic structures.

Ultrasound provides a detailed view of the portions of the tape which run between the urethra and vagina. It is excellent for assessing the position of this portion of the tape and for identifying complications such as urethral or bladder extrusion. Because mesh sits deep within the pelvis, transvaginal or transrectal probes are required to get the best possible quality images of the mesh. characteristics may suggest an aetiology of patients’ symptoms and MRI also allows for the identification of other pathology which may contribute to the presenting issues.

In our opinion, imaging informs decision-making in MDT meetings and allows the surgical team to better plan any intervention they perform. At present, there is some limited evidence regarding the efficacy of US and little to no published data regarding MRI (Duckett J, 2020). The mesh centres are collecting data, and analysis will validate the utility of imaging for management. These analyses will be shared so other centres can also benefit from experience.

Informed consent and patient information Much of the controversy over mesh insertion and complications has centred on governance issues and whether women gave fully informed consent. It is vital that mesh centres provide women with information on the risks and benefits of the full range of options for their symptoms. This is tailored to the individual woman in line with GMC guidance and according to the ‘Montgomery’ principle. This includes information leaflets that have been produced in partnership with the British Society for Urogynaecology (BSUG), the British Society of Urological Surgeons (BAUS), the Patient Information Forum alongside NHS England. Patient decision aids can also guide women through their choice of management (BSUG, 2021).

Patient outcome data, research and audit It is recognised that there is no high quality data comparing outcomes of different techniques of mesh removal surgery (IMMDS, 2020) (Giarenis I, 2020). Evidence to guide practice has relied on cohort studies (Carter P, 2020) (Toia B, 2021 ) (Forzini T, 2015). Patient reported outcome measure (PROM) questionnaires are utilised to document progression in symptoms from baseline and after treatment. Mesh centres in the UK are working with patient groups and NHS England to agree a standardised PROM so that data can be pooled across mesh centres for the future. Regular audit of outcomes and complications forms part of this governance structure. NHS Digital are supporting the establishment of a central mesh complications and outcomes registry but, at present, this data is captured in individual centres. Safety reporting to the MHRA is undertaken. Education and training The surgical management of mesh removal has not been credentialled yet by any professional body, and thus multiple techniques have been developed over the years. Urologists tended to favour endoscopic laser of mesh fibres whereas urogynaecologists tended to ‘oversew’ exposed mesh or ‘trim fibres’. Both approaches have never been fully evaluated. Over time, mesh removal surgery has evolved to include vaginal removal of mesh, paralabial/groin dissections to remove obturator mesh arms, retropubic dissections, female urethroplasty, fistula repair, bladder and/or ureteric reconstruction, and bowel resection. There is a skills gap in more complex mesh removal surgery (IMMDS, 2020). The UK mesh centres are working to build skills and support formal credentialling of expertise. Cadaveric workshops, mentoring and proctoring across surgical specialities will improve training in this field. Annual mesh congress meetings will encourage group learning and collaboration across centres.

Summary The evolution of the currently recognised problems with polypropylene mesh and the lessons that have been learnt and continue to be learnt from these have offered a real opportunity to develop an integrated service that brings together surgical, medical, and psychological expertise to support and benefit patients who have previously been let down by the lack of a dedicated infrastructure. Together, clinicians, patients, and advocates have the ability to facilitate pathways that will offer the highest quality of care, evolve the understanding of the best and tailored management pathways, and communicate this information to national and international clinical audiences. We hope that the success of this model of care will disseminate to all surgical practices for the benefit of all patients.

Disclosures Intra-operative images and radiology images used with permission of patients for publication.

Fig. 3: Transverse view of urethra on transrectal ultrasound showing urethral extrusion of mesh Fig. 5: Intra-operative view of groin dissection to remove TVTO References

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