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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 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." 


Christopher K Harding
Chair - BAUS Subsection of Female, Neurological and Urodynamic Urology (SFNUU)

Information on the safety of mesh surgery

NHS England has prepared leaflets on vaginal mesh insertion - click the links below:

  1. Information for patients on vaginal mesh tape insertion for stress urinary incontinence;
  2. Information for GPs about recognising & referring mesh complications;
  3. Appendix to 2: information for health professionals on mesh implants.
          (not currently available - waiting for corrections to be completed by NHSE)

Concerns about the safety of mesh slings have been raised because of short-term & long-term problems that have arisen. For some women, these problems have been serious and life-changing. Several reports addressing these concerns have now been published and are shown below in chronological order:

 TITLE OF REPORT     DOCUMENT CLICK LINK(S)
YORK HEALTHCARE ECONOMICS CONSORTIUM INITIAL REPORT ON SAFETY & ADVERSE EFFECTS OF VAGINAL MESH (FOR MHRA) Initial Report (Nov 2012)
MHRA SUMMARY OF THE EVIDENCE ON THE BENEFITS & RISKS OF VAGINAL MESH IMPLANTS Final Report (Feb 2015)

THE SCOTTISH INDEPENDENT REVIEW

Interim Report (Oct 2015) **
BAUS response to interim report Final Report (Mar 2017)

THE NHS ENGLAND MESH OVERSIGHT GROUP REPORT

Interim Report (Dec 2015) **
BAUS response to interim report Final Report (Jul 2017)
EUROPEAN ASSOCIATION OF UROLOGY (EAU) & EUROPEAN UROGYNAECOLOGICAL ASSOCIATION CONSENSUS STATEMENT Final Report (May 2017)
Proceedings of a Parliamentary Committee in Westminster Hall (Wed 18 Oct 2017) to debate a motion by Emma Hardy MP (Kingston upon Hull West & Hessle) on the problems of vaginal mesh View the debate on video
NATIONAL INSTITUTE FOR HEATH & CARE EXCELLENCE (NICE) OVERVIEW OF TRANSVAGINAL MESH REPAIR Final Overview (Dec 2017)
HOUSE OF COMMONS BRIEFING PAPER ON SURGICAL MESH IMPLANTS Briefing paper (Jan 2018)
THE INDEPENDENT MEDICINES & MEDICAL DEVICES SAFETY REVIEW (BY BARONESS CUMBERLEGE)  Draft terms of reference (Jul 2018)
RECOMMENDATIONS OF THE MESH PAUSE CLINICAL ADVISORY GROUP (From: Professor Keith Willett and Dr Kathy McLean) Briefing paper (20 Jul 2018)
(** FollowIng publication in 2015 of the two interim reports above, a telephone helpline, based in Glasgow, was set up. This helpline was under-utilised, so BAUS and The British Society of Urogynaecology (BSUG) were tasked with collating details of specialist centres where patients with mesh complications can be assessed and treated)
 

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 websitewith 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

Click on your nearest centre to identify individual surgeons who have agreed to treat mesh complications

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