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Letter from the Chairman
Dear member of TPFS & ACPGBI
Following on from the recent Tripartite and The Pelvic Floor Society meetings in Birmingham as well as reports within the media, you will be aware that the Scottish Health Secretary asked the Acting Chief Medical Officer Dr Eileen Keel to consider the suspension of the use of polypropylene medical devices mesh used for transvaginal prolapse repair. Some health boards have suspended their use in Scotland. In addition the use of mesh for urinary incontinence and sacrocolpopexy was to be investigated. This decision was not based on any new scientific data but rather due to patient support groups lobbying the Scottish parliament and the class actions in the USA against the pelvic mesh manufacturers (not surgeons) due to complications including mesh erosion. It has to be remembered that much of the litigation in the USA developed within an unregulated market of misleading company advertising, inadequately trained surgeons and the use of “unlicensed” materials. I am not aware of the current position or thinking of the DoH or NHS England, however NICE have published guidance on the use of mesh for pelvic organ prolapse.
The decision was unexpected and will almost certainly cause alarm to women not only in Scotland but also throughout the UK, particularly those already consented and awaiting surgery. I understand from colleagues in Scotland that it is also having ramifications in patients undergoing hernia surgeries! There is no equivalent minimally invasive (non-mesh based) method for stress incontinence surgery and the alternative of open colposuspension will increase morbidity and inpatient stay. Some patients suitable for TVT will not be suitable for colposuspension. In addition, colposuspension is no longer an index operation for uro-gynaecology subspecialist training. Further more, this potential blanket decision fails to distinguish the surgeries involved and groups all tapes for incontinence with mesh for prolapse repair as one. It also fails to acknowledge the countless numbers of patients with SUI and vault prolapse who have benefitted considerably from these interventions over the last 20 years. That said, surgery for pelvic organ prolapse has a poorly defined efficacy/evidence base and there is little doubt that the value of surgery in producing a good functional outcome has been grossly overstated in both Gynaecology and perhaps even in Colorectal surgery.
In the absence of National Institute for Health and Care Excellence guidance, I am writing to all Members of the ACPGBI and The Pelvic Floor Society involved in the surgical management of faecal incontinence, ODS and/or pelvic organ prolapse and performing laparoscopic ventral mesh rectopexy (LVMR) using a surgical mesh or implant to alert them to this decision and the actions required.
It is The Pelvic Floor Society's view that LVMR when performed correctly is a safe and effective operation with low mortality (0.09%) and morbidity. Mesh erosion rates are low (2.4%) but sometimes requires revision surgery. The latter when performed properly is associated with normalization of function. Biological implants have an erosion rate of 1%. Whilst effective in the control of external prolapse, there is as yet no long-term published data on functional outcomes for biologics used for ODS. Its long term efficacy in POP is also the subject of debate.
All LVMR interventions should be the subject of an on going continuous audit at an appropriate time interval. Ideally, such decisions should be the subject of a multidisciplinary process and local or trust governance procedures. Of particular relevance are the following important issues
The main value of the MDT is not only in the avoidance of missing any factors relevant to the decision making process and defining the most appropriate treatment for an individual patient but also in preventing clinicians with an over enthusiastic belief in their own favoured treatment modality e.g., LVMR pursuing an inappropriate course of treatment. It also allows a robust audit process to be developed, good research and more importantly improved communication with patients.
Surgeons who have not only been fully trained and mentored in the procedure, but are aware of the risks (specifically erosion and infection) should be the only individuals offering LVMR. The learning curve for LVMR is high @ 50 cases.
Mesh erosion is a function of the “honesty of reporting” as well as mesh material, suture type and length of follow-up. Current data would suggest that the median time to erosion is two years for synthetic mesh and 10 months for biologic implants. The risks with “standard” polypropylene approximate to 1.8% @ median 8 yrs FU, polyester 6.5% @ 4yrs, titanium coated LMW polypropylene 0.2% @ 3 yrs. Erosion is unrelated to age, menopausal status, hysterectomy or smoking and occurs equally in both external and internal prolapse patient groups. The use of a non-absorbable suture e.g., Ethibond may be a predisposing factor and should now be avoided (particularly with synthetic mesh and any vaginal stitches). To date there have been no recorded complications in men.
Inform every patient that the implantation of mesh is permanent and that certain problems may require revision surgery that may or may not fix the complication. TPFS recommend a move towards a standardisation of all consenting processes such that they comply with up-to-date evidence and risks not only at a UK level but also more importantly, at an individual or Trust level. Recent legal concern has arisen because of inappropriate and/or inadequate consenting without specific mention of relevant risks of LVMR at an individual level or the competency of the surgeon.
NICE recommends that POP mesh insertion should also be part of regular audit. We strongly recommend that all pelvic floor interventions, especially LVMR procedures and all incontinence operations, but particularly those involving mesh or an implant (to include SNS) are recorded on a local database and when available, TPFS website and the ACPGBI funded Dendrite system. This data will be mandatory and will form part of the process for accreditation of pelvic floor units in the UK.
Adverse event reporting
Mesh (and for that matter biological implants) used for LVMR are medical devices and to that end, adverse events must be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). Surprisingly, the MHRA is neither a government nor NHS funded agency but one funded directly by the pharmaceutical industry.
For all meshes these include: Erosion into the vagina, rectum and bladder, infection, pain, fistulation, mesh shrinkage, nerve injury and sexual difficulties. All NHS trusts and CCGs have a medical device liaison officer (MDLO) whose role is to promote and coordinate adverse incident reporting and help manage the dissemination of medical device alerts. Whenever a device related adverse event is reported to MHRA, the local MDLO and/or risk manager should also be informed.
Surgery for removal of mesh
Surgery for removal of LVMR, TVT or prolapse mesh, or repeat surgeries for incontinence, ODS or prolapse is both complex and potentially dangerous and must only be performed in units which can demonstrate relevant specialist care (audited by volume and outcome of surgery) and which will become recognised by TPFS, local commissioning groups or via the specialist commissioning processes in England.
Outside of published case series (some with very large numbers with good long-term follow-up) the evidence for LVMR is lacking i.e., there has been no RCT. Charles Knowles’ CapaCity study 3 has been designed to address this issue in 300 patients, carried out over 30 months in 10 centres. The same study will also aim to characterise a cohort of patients with chronic constipation and ODS. The second phase will look at best supportive/nurse led treatment and compare this with biofeedback. It is expected that 600 patients will be recruited to this arm. CapaCity 2, will examine rectal irrigation in those who have not got a satisfactory outcome from the above. TPFS has also endorsed Ian Lindsey’s DELivAR, a NHIR sponsored RCT comparing LVMR with Delorme’s rectal mucosectomy for external prolapse.
The above aforementioned pillars of clinical governance are all important considerations in providing quality care as well as maximising the opportunities to involve our patients in decision making by fully informing them of the procedures and respective risks.