VAGINAL MESH: HIGH VIGILANCE RESTRICTION PERIOD10th July 2018
Following the pause announced on the 10th July 2018 by the Secretary of State for Health and Social Care and the Chief Medical Officer in the use of synthetic mesh/tape to treat stress urinary incontinence (SUI), NHS England established a Clinical Advisory Group to operationalise this pause.
The attached document describes the actions to be taken and has been sent to all Medical Directors and takes immediate effect.
The British Society of Urogynaecologists (BSUG) does not agree with and strongly opposes the decision to pause/suspend the use of surgical mesh for stress urinary incontinence recommended by the APPG (All Party Parliamentary Group).
There are women on waiting lists for this procedure and depriving women of the surgery they are waiting to have done violates all principles of free will and free choice. It also goes against several key principals of the NHS constitution including its accountability to the public, communities and patients it serves.
The UK will be the first and only Country in the World to pause/suspend the use of the Midurethral Synthetic tapes for urinary incontinence. This decision is not based on any scientific logic or thinking. This is the single most researched incontinence procedure in the world and to therefore place a suspension on its use contradicts all the research, scientific evidence and guidance issued by national bodies. This procedure has been the mainstay of surgical treatment for women with stress incontinence over the last 20 years. Good quality data suggest 95% of women remain free from any complications after this surgery and the majority have markedly improved continence. Other surgical procedures have higher risks and complications.
The Independent Medicines and Medical Devices Safety Review has identified the conditions of lifting the pause/suspension in the use of surgical mesh. But BSUG have already achieved and fulfilled these criteria. Only trained surgeons now undertake incontinence procedures. The BSUG has called for mandating the use of the national database which provides a register of every continence procedure and allows reporting to the MHRA of complications through this registry. BSUG have also identified centres for dealing with SUI mesh removal.
BSUG are committed to ensuring the safety of surgical procedures undertaken for incontinence. It is equally important that women who need treatment are not precluded from receiving it. We therefore hope this unnecessary ban will be lifted immediately so the women of the UK can reaffirm their right to determine the treatments that are best for them.
Professor Jonathan Duckett
Download the PDF here
NHS Improvement - Statement on Mesh 10th July 2018 - Download here