Vaginal Mesh for Stress Urinary Incontinence and Prolapse

The British Association of Urological Surgeons (BAUS) welcomes the publication of the Independent Medicines and Medical Devices (IMMDS) review report “First Do No Harm” and would like to thank Baroness Julia Cumberlege, Sir Cyril Chantler and Simon Whale, along with all of the members of the review team, for their hard work over the past couple of years. 

Many of the Association's members have contributed to the evidence synthesis for the report which has included giving evidence directly to the review team and advising them on matters concerning stress urinary incontinence (SUI) and pelvic organ prolapse (POP) surgery.  We are grateful for all of these contributions.  The Association is fully supportive of the report’s findings and recommendations and recognises the suffering some women have had to endure as a result of polypropylene mesh placed for stress urinary incontinence and pelvic organ prolapse. 

We would like to begin the process of recovery immediately, with a primary objective of regaining the trust of mesh-injured patients.  To this end we will pledge to guide our members appropriately with regard to the implementation of the recommendations made in the IMMDS report:

• Apology – the IMMDS report recommends a fulsome apology to mesh-injured patients and BAUS was first of the speciality associations to do this. In 2019, during the IMMDS oral evidence hearing, the BAUS mesh lead, Chris Harding stated “Yes, we do owe women an apology, without doubt, and I would give that unreservedly on behalf of BAUS”
• Patient Safety Commissioner – the report recommends the appointment of a patient safety commissioner to champion the value of listening to patients. BAUS believes that this role should be independent and not allied to any of the professional societies.  Nevertheless, BAUS would wholeheartedly support the appointed commissioner on clinical matters where specialist knowledge is required.
• Redress Agency – the review has recommended an independent redress agency be created for those harmed by pelvic mesh to aid with the resolution of disputes between patients and the healthcare system.  BAUS is happy to assist this process and would specifically offer topic-specific knowledge as and when required.
• Specialist Mesh Centres – the creation and set-up of specialist mesh centres to provide comprehensive treatment for mesh complications has been recommended and BAUS has been at the heart of this process since its inception.  Several BAUS members have assisted NHS England (NHSE) and the Department of Health and Social Care (DHSC) with this workstream and the announcement of these centres is expected in the near future.  We believe that there is a high degree of surgical expertise amongst our members and several of them have already accrued significant experience in mesh removal surgery and published their data, in line with the plea for “data-sharing” made by the IMMDS review committee today. The report acknowledged that further research and expert consensus is needed with regard to some of the issues surrounding the treatment of mesh complications and to this end the BAUS mesh lead is liaising with the International Continence Society (ICS) on the creation of a consensus document to be published later in the year. This ICS initiative is currently led by a BAUS member and the committee includes representation from two other members of the Association.
• Pelvic Floor Registry – Baroness Cumberlege has recommended the creation of a central patient-identifiable database and BAUS has again been fully represented and involved in this NHSE-led project at all stages.  We have always stood firm on our view that such a registry should include all surgical treatments for SUI and POP to allow for meaningful comparisons to be made and provide sufficient data to aid the process of fully informed consent when a patient is considering a range of potential treatment options.  We are hopeful that the National Pelvic Floor Registry will be piloted by the end of this year.
• Transparency of payments made to clinicians – the IMMDS report recommends that the GMC register be expanded to include a list of financial and non-pecuniary interests for all doctors. BAUS will pledge to engage fully with this process which will enhance the degree of transparency related to such matters.
• Creation of a government-led task force – the review’s final and perhaps most important recommendation is that the government set-up a task force to implement their recommendations. We would be very keen for representation on this task force and the Association is completely supportive of the recommendations made and will do everything required to ensure they are put into practice in a rapid and efficient manner.

BAUS would like to confirm that Mr Chris Harding, immediate past Chairman of the Female, Neurological and Urodynamic Urology Executive Committee will continue in his role as BAUS Mesh Lead for the foreseeable future, and the association will prioritise this issue for as long as is necessary.  "If any of our membership has any questions or would like clarification on any particular issues they are encouraged to contact the BAUS office directly."

BAUS has noted the contents of the NICE guideline linked above, released on 2 April 2019.

There has already been significant concern raised in the media regarding the guideline recommendation that patients should be able to choose between a range of procedures for the surgical treatment of stress urinary incontinence, including the use of mid-urethral mesh sling procedures.

BAUS would like to make its position absolutely clear to the membership.

Although we are strong advocates for patient choice, we would currently advise members to continue to abide by the recommendations set out by the Independent Medicines and Medical Devices review, which were supported by the Department of Health and Social Care in Summer 2018. The pause on mesh surgery for stress incontinence (see below) remains in place, and this will be the case until a series of pre-specified conditions are met.

The publication of the NICE guideline does not change this and we would advise members not to use mesh for the treatment of stress incontinence, in either the NHS or the independent sector, until further notice."