Vaginal Mesh Insertion for Stress Urinary Incontinence (SUI)
Transvaginal sling procedures using synthetic, polypropylene mesh (pictured right) have been widely performed in women by urologists (for stress urinary incontinence, SUI) and by gynaecologists (for SUI and pelvic organ prolapse, POP). As a general rule, urologists perform mesh procedures primarily for SUI and do not normally treat POP.
Hospital Episode Statistics (HES) show that 23,742 SUI procedures were performed in the UK between the start of 2014 and the end of 2016: 3,587 (15%) of these were carried out by urologists and 20,155 (85%) by gynaecologists.
BAUS has an information leaflet on synthetic mesh slings (last revised in February 2018).
Click here to see Surgical Outcomes Audit data on surgery for SUI, published elsewhere on this website.
Statement to BAUS members following publication of the Cumberlege Report (8 July 2020)
“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."
Chris Harding (BAUS Mesh Lead)
Tim O'Brien (BAUS President)
Statement to BAUS members regarding NICE SUI Guidelines (April 2019)
“BAUS has noted the contents of the NICE guideline (NG123) on urinary incontinence and pelvic organ prolapse in women, 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."
Chris Harding - on behalf of the BAUS Subsection of Female, Neurological and Urodynamic Urology (SFNUU)
Information on the safety of mesh surgery
Halt on the use of surgical mesh for SUI surgery (** effective from 10 July 2018 **)
A “period of high vigilance restriction” regarding vaginal mesh surgery has now been announced by the Cumberlege review (see table in the dropdown above ("Information on the safety of mesh surgery"), mirrored on the UK Parliament website, with effect from 10 July 2018.
BAUS welcomes any recommendations that will help establish the nature and extent of complications suffered by women undergoing these types of surgery. Furthermore, we are keen to support the implementation of processes that will ensure existing patients with complications from mesh surgery are given the opportunity to be managed in centres with the required levels of experience, expertise and resources: click below to access information on this website about these centres.
Click here to read the response of the British Society of Urogynaecology (BSUG).
BAUS will now engage with NHS England, the Department of Health & Social Care and the Cumberlege review team, via our relevant section leads, to ensure that all conditions set out by the review are met before the lifting of this period of temporary suspension. Click here to see details of the members of the Medical Devices Safety Review HCWS84 who will be assessing the situation, and click here for general details of the review.
Reviewing women with mesh complications
Trusts that agree to see women with mesh problems after SUI or POP surgery are obliged to agree that they will comply with the criteria set for discussing all patients at a joint meeting, to help determine best treatment options. The essential requirements are that:
- a designated urologist, gynaecologist, colo-rectal surgeon and pain relief specialist are available;
- patient discussions are carried out in the setting of a multi-disciplinary team (MDT) meeting; and
- the application by the centre is agreed & signed-off by the Trust's Medical Director.
Each Unit Lead is responsible for submitting data on all patients to a national database, and for reporting adverse incidents to the MHRA. The Clinical Lead will take overall responsibility for the centre. Other medical staff may also be involved in patient management, with the approval of the Clinical Lead. Ideally, this should include links with other specialties such as Pain Management and Clinical Psychology who can be involved, as necessary, following MDT case discussion. This will be a local arrangement, and each unit can discuss patients with additional staff as appropriate.
Find a mesh review centre
The list of mesh centres (below) was compiled to assist women who had informed BAUS that they were unable to access clinical pathways for mesh complications. Inclusion on this list does not constitute accreditation but is intended to signpost women with mesh complications to their nearest centre which will enable more efficient access to appropriate treatment. We are awaiting the announcement on NHS England approved mesh removal centres within the next few months and will update this webpage accordingly.
Click on your nearest centre to identify individual surgeons who have agreed to treat vaginal mesh complications
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