The government has accepted the use of vaginal mesh implants to treat complications after childbirth should be stopped immediately to prevent further risk of “life-changing and life-threatening injuries” to women. It would effectively suspend the use of vaginal mesh implants in NHS hospitals, which would represent a major victory for campaigners. It follows an independent inquiry, ordered in February by the health secretary, Jeremy Hunt, which concluded the surgery must be stopped until steps have been taken to mitigate the risks to patients.
Julia Cumberlege, who chaired the 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.”
Until 2017, government guidelines had stated the surgery was safe and effective. However, an investigation by the Guardian found 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 in the past decade.
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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 are mounting over the severe complications suffered by large numbers of patients, including chronic pain, mesh cutting through tissue into the vagina and being left unable to walk or have sex. Johnson & Johnson, whose subsidiary Ethicon produces one of the most widely used mesh products, is fighting a major class action in Australia. The Guardian revealed in August that thousands of women have undergone surgery to have vaginal mesh implants removed during the past decade, suggesting that about one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted due to complications.
Baroness Cumberlege has put forward conditions that need to be met by March 2019 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 only undertake the operations if they are appropriately trained, and only if they undertake 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.
“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,” said Cumberlege.
“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 and Social Care and NHS England support our recommendation, and I look forward to its quick implementation.”
Carl Heneghan, a 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 on to the market, the lack of long-term evidence to inform their use and the inadequate response of health professionals to emerging harms.
“It 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 healthcare goes badly wrong and ensuring healthcare is based solely on high-quality research evidence.”
Kath Sansom, the founder of the 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. It is testament to people power. Our members have written, emailed, attended parliament and lobbied to get this result and I am delighted.”
However, she added: “There is no suspension in Northern Ireland or Wales. It is paramount these women are also protected by a suspension.”
