In a landmark moment for thousands of women across the UK, it has been announced that the NHS will immediately halt the use of surgical mesh for treating stress urinary incontinence (SUI).
Mesh
The news follows recommendations from the Independent Medicines and Medical Devices Safety Review which states that there must be an immediate suspension in the use of surgical mesh for treating SUI.
Chair of the review, baroness Julia Cumberlege has advised the NHS and the Department of Health and Social Care that until a set of conditions to mitigate the risks of injury are met, surgical mesh should not be used. The NHS and the DoH have accepted the recommendation that these conditions should be met by March 2019.
Specifically, the review sets out five conditions which the NHS must meet by March 2019. These include surgeons only undertaking operations for SUI if they are appropriately trained and do them regularly; every operation is reported to a national database; a register of mesh operations is maintained; reports of complications through MRHA is linked to the register; and specialist centres for SUI mesh procedures are identified and accredited to help those affected by mesh, through removal procedures and other aspects of care.
The conclusions come following meetings held with women and families who have been unfortunately affected by surgical mesh procedures.
Announced by the government in February, the review examines the three major health scandals, including primodos, sodium valproate and of course, vaginal mesh.
Interestingly, from the evidence acquired within the review, Baroness Cumberlege states that the review team ‘has not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications’.
This is despite former health and social care secretary Jeremy Hunt mentioning that a full ban on vaginal mesh products was not an option as ‘clinical experts here and abroad agree that when used appropriately, many women gain benefits from this intervention’.
Speaking about the review, baroness Cumberlege 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.
“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.”
In 2017, NICE recommended that surgical mesh for vaginal wall prolapse should only be used for research purposes. More recently it was announced that a review into the use of mesh on urinary incontinence in women is being delayed by two months.
Women and politicians have been tirelessly campaigning to stop the use of mesh for certain medical procedures as accounts of pain and life-changing effects have come to light over the years.
Whilst a welcome step towards proper regulation of these devices, the recommendation does not apply to mesh used for rectopexy procedures, though it is being considered separately within the review.
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.
"We now hope that Baroness Cumberlege adds rectopexy mesh to the suspension. This is even more taboo and more embarrassing than urinary incontinence. Women suffer the same grave, life changing complications. Many are suicidal. The main proponent of this mesh, Anthony Dixon, is suspended from Bristol NHS Trust and around 200 of his patients have been contacted to ask if they are suffering. It is vital there is a #metoo on rectopexy mesh."
"It is testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result and I am delighted."
“Sling the Mesh wants to ensure that, as a matter of urgency, women booked in for TVT, TVTO and TOT mesh sling incontinence operations in both NHS and private hospitals across the UK now have those surgeries cancelled.”
Chair of the APPG on Surgical Mesh Implants and labour MP Owen Smith, 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.”