Curb on Mesh Implants for Stress Urinary Incontinence

Peter Russell

July 12, 2018

The use of vaginal mesh implants to treat complications after childbirth will be "paused" in NHS hospitals in England, the Department for Health and Social Care (DHSC) has announced.

It follows preliminary recommendations from an independent review set up by the then Secretary of State, Jeremy Hunt, which said that surgical mesh should not be used for the treatment of stress urinary incontinence until adequate safeguards were in place to reduce the risk of injuries.

The Government said it accepted the recommendation after seeking advice from the chief medical officer and senior clinicians. It agreed that the pause should be extended to include vaginally inserted mesh to treat pelvic organ prolapse.

'Women Are Suffering Terribly'

The procedure involves inserting a net-like fabric into the vagina to support the bladder, womb or bowel. Thousands of women have reported disabling complications as a result of the procedure.

Former health minister Baroness Julia Cumberlege, who is chairing the review, said: "I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly. Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now."

Independent Review

The Independent Medicines and Medical Devices Safety Review was set up to investigate how the healthcare system had responded to concerns raised by patients and families about three medical interventions. These are:

The review may make recommendations regarding these interventions but also about how the healthcare system could improve its response to concerns raised about other medicines and medical devices in the future.

Vaginally inserted meshes will only be used in England when there is no alternative "and after close and comprehensive consultation between patient and clinician, with rigorous oversight and governance at all times", the DHSC said.

NHS England said it would now work with other health agencies to pause procedures quickly and safely.

NHS England and NHS Improvement have written to providers to ensure that provider medical directors and nurse directors are equipped with advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment.

Conditions Set for Lifting the Pause on Procedures

The conditions of lifting the pause in the use of surgical mesh, which the review said should be met by March 2019, are that:

  • Surgeons should only undertake operations for stress urinary incontinence if they are appropriately trained, and only if they undertake operations regularly

  • They report every procedure to a national database

  • A register of operations is maintained to ensure every procedure is notified and a record kept of each woman who has undergone the surgery

  • Complications reported via the Medicines and Healthcare products Regulatory Agency (MHRA) are linked to the register

  • There should be identification and accreditation of specialist centres for stress urinary incontinence mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh

The latest development follows guidance in December 2017 from the National Institute for Health and Care Excellence (NICE) which said there were "serious but well-recognised safety concerns" about the use of mesh and that the procedure should only be used for research.

The Scottish government suspended the use of mesh for stress urinary incontinence in 2014.

Mesh used for bowel patients (rectopexy) in England has not been included in the temporary suspension and will be considered separately by the review.

Owen Smith MP, chair of The All Party Parliamentary Group on Surgical Mesh Implants tweeted that the decision to suspend mesh procedures "is welcome and overdue but raises significant questions about our regulators, the MHRA and NICE. Why did they not listen to the worries about mesh? Why did it take a sustained campaign and an independent review to act?"


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