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Mesh operations curbed due to safety concerns

Risk mitigation conditions must be set up

Jo Carlowe

Tuesday, 10 July 2018

An immediate curb has been placed on surgical mesh procedures following safety concerns.

The Independent Medicines and Medical Devices Safety Review has concluded that there must be an immediate pause in the use of surgical mesh for the treatment of stress urinary incontinence (SUI).

The Review’s conclusion follows meetings held in the initial stages of its work, over recent months, with women and families adversely affected by surgical mesh procedures.

Baroness Julia Cumberlege, chair of the Review, has advised the Department of Health and Social Care and NHS England that 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. These conditions should be met by March 2019. The Department and NHS England have accepted the recommendation.

Commenting, Baroness Cumberlege, said: “We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively. We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.

“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.”

She added: “My team and I are in no doubt that this pause is necessary. 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.

“At this stage in our Review we are not recommending a ban, but a halt to procedures until the conditions we have laid down are met. I am pleased that both the Department of Health & Social Care and NHS England support our recommendation, and I look forward to its quick implementation.”

This follows NICE’s 2017 guidance that mesh for vaginal wall prolapse should only be used in the context of research. In 2014 the Scottish government put in place a suspension in the use of mesh for SUI.

England’s chief medical officer Professor Dame Sally Davies said: “For some patients mesh has had unwanted and serious consequences, which is why guidance has been issued to ensure the right patients are offered the procedure, properly informed and operated on by expert surgeons.

“However, until we are clear this guidance is being properly implemented, ministers have accepted my recommendation to pause its use to ensure patients are receiving a high quality and consistent service.

“This will still be a treatment of last resort for some, so carefully selected patients will continue to have access to the operation in discussion with their consultant.”

Today’s recommendation does not apply to mesh for rectopexy procedures, which will be considered separately by Baroness Cumberlege’s Review.

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

  1. Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly;
  2. They report every procedure to a national database;
  3. A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;
  4. Reporting of complications via MRHA is linked to the register;
  5. 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.

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