Clinical Negligence & Catastrophic Injury Solicitors
Vaginal mesh implants suspended.
The government has suspended the use of vaginal mesh implants to treat complications after childbirth immediately to prevent further risk of “life-changing and life-threatening injuries” to women.
The instruction suspends the use of vaginal mesh implants in NHS hospitals and follows an independent inquiry which concluded the surgery must be stopped until steps have been taken to mitigate the risks to patients.
Chair of the review, Julia 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.”
Until 2017, government guidelines had stated the surgery was safe and effective. However one in 15 women given a mesh implant later required surgery to have it removed, with some suffering life-altering complications.
In December, National Institute for Health and Care Excellence (Nice) guidelines recommended that mesh should no longer be used to treat prolapse. The latest recommendations relate to the treatment of urinary incontinence, for which tens of thousands of women have been given the implants, which are made from polypropylene, in the past decade.
The implants have been widely used as a simple, less invasive alternative to traditional surgical approaches for treating urinary incontinence and prolapse, conditions that can commonly occur after childbirth. For the majority of women the operation is successful.
However, concerns mounted over the severe complications suffered by large numbers of patients, including chronic pain, mesh cutting through tissue into the vagina and women being left unable to walk or have sex.
Baroness Cumberlege has put forward conditions that must be met before the use of vaginal mesh can be considered safe. The Department of Health and NHS England have accepted the recommendation.
The conditions are that surgeons should undertake the operations only if they are appropriately trained, and if they perform the operations regularly.
The review also recommended the creation of a registry to keep track of any complications.
In 2014 the Scottish government put in place a suspension in the use of mesh for stress urinary incontinence.
Baroness Cumberlege added: “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 complications.
“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 and Social Care and NHS England support our recommendation.”
Professor of evidence-based medicine at Oxford University, Carl Heneghan, said: “The ban on mesh for stress urinary incontinence reflects the inadequate evidence base that let risky devices on to the market, the lack of long-term evidence to inform their use and the inadequate response of health professionals to emerging harms.
“We now need to learn some serious lessons and not repeat the mistakes of the past. Including listening to patients when healthcare goes badly wrong and ensuring healthcare is based solely on high-quality research evidence.”