Surgical mesh for stress urinary incontinence to be halted immediately in EnglandBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3035 (Published 10 July 2018) Cite this as: BMJ 2018;362:k3035
The use of surgical mesh for stress urinary incontinence is to be suspended immediately following a recommendation by the Independent Medicines and Medical Devices Safety Review.1
The review was announced by the government in February after pressure from campaigners and the all party parliamentary group on surgical mesh implants.23 An increasing number of women have reported complications after mesh surgery including debilitating pain, infection, inflammation, loss of sex life, and mobility problems.
The announcement comes just days after the review began to take evidence from women affected by mesh injury. Julia Cumberlege, who chairs the review, said she was “appalled at the seriousness and scale” of the stories she had heard from women and their families.
She said: “We must stop exposing women to the risk of life changing and life threatening injuries. We must have measures in place to mitigate the risk, and those are sadly lacking at the moment.” She said that the review had not seen evidence on the benefits of mesh that outweighs the severity of suffering caused by mesh complications.
Cumberlege has said surgical mesh should not be used for the treatment of stress urinary incontinence until a set of conditions to mitigate the risks of injury are met and these should be in place by March 2019. The Department of Health and NHS England have accepted her recommendations.
The conditions include:
● Surgeons should only undertake the operations for stress urinary incontinence if they are appropriately trained and if they do them regularly
● All procedures should be reported to a national database
● A register of operations should be maintained and the woman identified who has undergone the surgery
● The reporting of complications through the Medicines and Healthcare Regulatory Agency should be linked to the register
● Specialist centres should be identified and accredited for mesh procedures, removal procedures, and other aspects of care.
The move follows guidance in 2017 from the National Institute for Health and Care Excellence that mesh for vaginal wall prolapse should only be used in the context of research.4 The recommendation does not apply to mesh for rectopexy procedures, which will be considered separately by the review.
The British Society of Urogynaecologists (BSUG) said they were strongly opposed to the decision to suspend the use of surgical mesh for stress urinary incontinence. BSUG chair, Jonathan Duckett, said: “This decision is not based on any scientific logic. This is the single most researched incontinence procedure in the world and to place a suspension on its use contradicts all the research, evidence, and guidance issued by national bodies.” He added: “This procedure has been the mainstay of surgical treatment for women with stress incontinence over the past 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.”
BSUG said it has already fulfilled the criteria set out by Cumberlege, including only having trained surgeons undertaking incontinence procedures.
Owen Smith, chair of the all party parliamentary group on surgical mesh implants, said: “Baroness Cumberlege should be applauded for making this definitive statement just days after her review began taking evidence from women affected by mesh injury. She has obviously been left in no doubt—as those of us who have listened to women injured by mesh are in no doubt—that the risks far outweigh any benefits.”
He added that he hoped that Wales, Scotland, and Northern Ireland would follow England and halt the procedure.
Kath Sansom, founder of the campaign group Sling the Mesh which has lobbied hard for the change, said: “We now hope that Baroness Cumberlege adds rectopexy mesh to the suspension. This is used when patients suffer faecal incontinence after a rectal prolapse. This is even more taboo than urinary incontinence.” She added: “The same plastic material is used for hernia repairs and is causing grave problems for members of our support group.”
Hundreds of women are taking legal action against the NHS and the makers of the implants. Linda Millband, from Thompsons Solicitors who are supporting some of the affected women, said. “There will also be legitimate questions as to why procedures, such as rectopexy for bowel patients, have not been included in this ban. Any mesh, wherever it is used, is dangerous, destructive, and, in some cases, deadly.”