RCOG statement on report commissioned by the MHRA on vaginal tape and mesh implants

This report by York Health Economics Consortium on behalf of the Medicines and Healthcare Products Regulatory Authority (MHRA) presents summaries of the safety/adverse events of vaginal tapes/slings/meshes for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

These summaries have been developed using data from systematic reviews of the effects and safety of vaginal tapes/slings/meshes, published in the last 10 years.

The studies (or treatment arms/groups) examined the following outcomes: pain persisting after six months, mesh exposure, sexual problems or pain following the procedure, and procedures to remove the device or organ perforation (for POP only).

The authors found that adverse event rates associated with the various surgical techniques using vaginal tapes for SUIs are generally in the range 1-3% and adverse event rates for surgical techniques using vaginal meshes for POP are in the range 2-15%.

Dr David Richmond, RCOG Vice President (Clinical Quality) said:

“Urinary incontinence and pelvic organ prolapse affect many women and can have an enormous impact on their day to day quality of life.

“Women seeking treatment for incontinence and prolapse should discuss all the options with their doctors including conservative non-surgical interventions. Surgical procedures can improve symptoms for certain women. However, women need also to know that any operation carries some risk whether with or without the mesh described in this report.

“The RCOG welcomes this report. It shows that adverse rates for vaginal tapes are quite low. For vaginal meshes the adverse rates are higher in some studies. It is important that clinicians adhere to the NICE guidelines and inform patients of the risks and benefits of any procedure.”

Thursday 22 November 2012

Ends

The full report can be found here.

 

Information for women considering this procedure or who are experiencing problems with an implant can find information on the MHRA website:

Stress urinary incontinence

Pelvic organ prolapse

NICE guidelines on urinary incontinence can be found here.

Date published: 22/11/2012
Published by: Naomi Weston

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