This decision followed a recommendation from Baroness Cumberlege, chair of the Independent Medicines and Medical Devices Safety Review, which came after meetings held with women and families adversely affected by surgical mesh procedures. There is no concurrent change in the evidence base.
Approximately 7,245 tape procedures for SUI were performed in NHS hospitals (or funded by the NHS in private hospitals) in England in 2016/17. This had reduced by 48% since 2008/9. In 2016/17, approximately 2,680 patients had a mesh procedure for prolapse – this data does not include privately funded procedures in private facilities, or procedures carried out abroad.
The high vigilance restriction will remain in place until the following conditions are met:
- Surgeons should only undertake operations for stress urinary incontinence (SUI) if they are appropriately trained, and only if they undertake operations regularly
- Surgeons report every procedure to a national database
- A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery
- Reporting of complications via MHRA is linked to the register
- Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh
- NICE guidelines on the use of mesh for SUI are published
The Mesh Working Group identified a series of actions to optimise care for women undergoing treatment for stress urinary incontinence and pelvic organ prolapse in their report in 2015, which have since been implemented by the Mesh Oversight Group. The final report of this group was published in July 2017 and can be found here.
See full details here.
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