Government review team is “appalled by the scale of tragic stories”. The most commonly used women’s mesh implant is suspended
PUBLISHED: 00:01 10 July 2018
Mesh implants to treat incontinence are being stopped immediately in hospitals across England after the Government stepped in just days after launching a safety review.
The news has prompted celebrations for women across the UK in Sling The Mesh campaign, launched by our reporter Kath Sansom, in June 2015 with just 20 women.
The group now has more than 6,100 members.
Baroness Julia Cumberlege, leading the Government 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.
“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.”
She added that it should not be used 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.”
Owen Smith, chairman of the All Party Parliamentary Group into mesh implants, said : “This is wonderful news and it is long overdue, it is also a complete vindication of all those women who have campaigned tirelessly to suspend mesh and highlighted the damage the procedure has caused to many women.
“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.
“Of course the reality of the situation is surgeons have already recognised that fact which is why the use of mesh has declined so precipitously over recent years.
“I’m pleased that Jeremy Hunt has accepted Baroness Cumberlege’s recommendations and I expect that he will come to the House of Commons today to formally announce the decision and assure MPs that no mesh operations will take place during this suspension.
“I hope that ministers in Wales and Scotland and civil servants in Northern Ireland will follow suit and halt the procedure.
“The APPG on Surgical Mesh Implants, which I founded a year ago, has called from the beginning for the suspension of mesh and I am delighted that our call and the voices of women injured by the product are now being listened to.”
Kath Sansom, 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.
“It is testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result.
“We now hope Baroness Cumberlege adds rectopexy mesh to the suspension. This is used when patients suffer a rectal prolapse. This is even more taboo and more embarrassing than urinary incontinence. It is vital there is a #metoo on rectopexy mesh.”
As a matter of urgency, women booked in for TVT, TVTO and TOT mesh sling incontinence operations in both NHS and private hospitals must cancel, Kath added.
In 2014 campaigners from Scottish Mesh Survivors successfully lobbied Scottish government to call for a mesh suspension, but some health trusts continued to use it.
Carl Heneghan, professor of evidence based medicine at Oxford University, said: “The ban on mesh for stress urinary incontinence reflects the inadequate evidence-base that let risky mesh devices onto the market, the lack of long-term evidence to inform their use and the inadequate response of health professionals to emerging harms.
“The ban is the right thing to do as it prevents further unnecessary injuries, however, it has come too late for many thousands of women who face lifelong disabling complications.
“We now need to learn some serious lessons and not repeat the mistakes of the past. Including listening to patients when health care goes badly wrong and ensuring healthcare is based solely on high-quality research evidence.”
Linda Millband, of Thompson’s Solicitors said: “For all the women we act for, injured by the use of mesh for stress incontinence, the suspension comes too late - but if it prevents one more woman being left injured for life, as many of our clients have been, then that is welcome.”
She added that any mesh, wherever it is used, “is dangerous, destructive and in some cases, deadly.”
Baroness Julia Cumberlege, chair of the review, has advised the Department of Health and Social Care and NHS England that it should not be used until a set of conditions to mitigate the risks of injury are met by March 2019.
The Department and NHS England have accepted.
This follows NICE’s 2017 guidance that vaginal prolapse mesh is banned.
• Surgeons should only undertake operations if they are appropriately trained and do them regularly.
• Women are logged on a national database.
• A register of operations is kept.
• Complications are reported to MHRA by being linked to the register.
• Specialist centres for mesh removal and other aspects of mesh complication care must be accredited.
The safety review was announced in February 2018 by health secretary the Rt Hon Jeremy Hunt MP, who said the response to concerns was “not good enough” on three women’s health issues - mesh, the hormone pregnancy test Primodos and the anti-epileptic drug sodium valproate.
Rectopexy mesh will be looked at as part of the ongoing review.