Transvaginal mesh implants independent review: final report

Appendix B - Remit

The remit of the Review is to evaluate both the efficacy and the extent and causes of adverse incidents and complication rates associated with SUI and for POP. The Review Group recognises that these are two very different conditions and will take account of this.

It will involve the clinical and patient community and will have the means both of identifying and determining the causes of issues where this is possible, finding and implementing solutions.

Purpose

1. To determine the safety of vaginal mesh implants for both SUI and POP in Scotland and to compare it to international standards. Information on how many women are experiencing complications and possible reasons for these complications will be examined.

2. To determine the relative efficacy of surgery for SUI and POP with and without the use of mesh or tapes.

The Review will take account the Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks of the European Commission, the MHRA report on Safety/Adverse Effects of Vaginal Tapes/Slings/Meshes for Stress Urinary Incontinence and Prolapse and the output from the UK Working Group on surgery using vaginal mesh.

This will involve:

• Putting the needs of patients first (both need for effective treatment and protection from harm).
• Appraising the current research evidence for the efficacy of these tapes and meshes relative to alternative surgical and non-surgical treatments from unbiased sources, such as Cochrane reviews and randomised controlled trials ( RCTs) along with verified alternative sources.
• Reviewing the information on adverse incidents and complications for mesh used for SUI and POP in Scotland and elsewhere.
• Understanding, with the clinical and patient communities, possible reasons for any complications.
• Identifying where possible which complications arise from the device itself, the insertion technique or the procedure as a whole.
• Identify where possible improvements which could improve efficacy, safety or decrease complications.
• Fostering clinical consensus to recommend appropriate clinical pathways for mandatory reporting of any complications or adverse incidents, making recommendations to the Cabinet Secretary of changes that may be required to improve quality, safety or efficacy.

Scope

In determining the appropriate course of action on this issue, the Group is able to consider:

• The available data on procedures using mesh implants for pelvic floor surgery, including data on efficacy and complications compared to alternative surgical and non-surgical treatments.
• Identifying best practice standards in management of SUI and POP.
• Any issues that may lead to clinical practice not conforming to best practice standards.
• Reported safety issues with devices, including improvement in reporting adverse events.
• Barriers to regular prospective auditing of results of surgical procedures.
• Short, medium and long-term patient follow-up.
• Identification of best practice in managing both treatment failure and complications, and resources to do so.
• Whether the information provided to patients before undergoing these procedures should be updated.