Vaginal mesh surgery ‘paused’ for some treatments
Ministers have accepted the recommendation from England’s Chief Medical Officer.
Vaginal mesh surgery is to be “paused” for some treatments in England, officials have announced.
Ministers have accepted a recommendation from the nation’s chief medical officer, who asked that “a pause in the use of vaginally inserted mesh to treat prolapse and tape/sling used to treat stress urinary incontinence is implemented through a high vigilance programme of restricted practice”.
The recommendation comes after an official review into the use of vaginal mesh called for an “immediate pause” in the use of surgical mesh for the treatment of stress urinary incontinence.
The Independent Medicines and Medical Devices Safety Review is yet to announce its terms of reference, but its chairwoman made the recommendation after gathering initial evidence from women and their families affected by surgical mesh procedures.
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 Dame Sally Davies, England's Chief Medical Officer
The review was announced by Health and Social Care Secretary Jeremy Hunt earlier this year.
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.”
This is incredible news and vindication for more than 6,100 members of Sling The Mesh who have been maimed by this operation and then ignored, some for years Kath Sansom, Sling The Mesh
Kath Sansom, founder of campaign group Sling The Mesh, said: “This is incredible news and vindication for more than 6,100 members of Sling The Mesh who have been maimed by this operation and then ignored, some for years.”
The news comes after review chairwoman Baroness Julia Cumberlege 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.
“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,” she said.
“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 Baroness Julia Cumberlege, review chairwoman
“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.
“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.”
In February Mr Hunt said a review had been launched into patient concerns about hormone pregnancy test drug Primodos, vaginal mesh and sodium valproate.
He said the review will examine how the NHS responds to safety concerns raised by patients about medicines or medical devices.
In particular it will look into concerns raised about the three health issues.
It will also consider whether any further action is required, including whether a full investigation or a public inquiry is necessary.
The review’s recommendation does not apply to mesh for rectopexy procedures – usually for external rectal prolapse – which will be considered separately.