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Labour MPs call for inquiry into use of vaginal mesh implants Health minister rejects calls for inquiry into vaginal mesh implants
(about 5 hours later)
Labour MPs have called for an immediate halt on the use of vaginal mesh implants, as a parliamentary debate was told that thousands of women had been exposed to unacceptable health risks. Labour and Conservative MPs have called for tighter restrictions on the use of vaginal mesh implants, in a parliamentary debate that heard how the lives of women had been avoidably blighted by complications linked to the surgery.
Addressing MPs in Westminster Hall, the Labour MP Emma Hardy, who called the debate, said there had never been adequate trials to support the introduction of mesh implants and that until evidence was reviewed their use should be suspended. Labour has called for an immediate suspension of the use of the controversial implants, which are used to treat incontinence and prolapse, with the shadow health minister, Jon Ashworth, arguing that thousands of women have been exposed to unacceptable health risks. Tory MP Sarah Wollaston, a former GP and chair of the health select committee, said “an absence of data and cavalier practice” had exposed women to unacceptable risks and meant it had taken a decade for problems with mesh to be acknowledged.
Hardy urged the government to launch an independent inquiry into what she called the “ongoing public health scandal” of serious complications affecting many women who have been treated for urinary incontinence and pelvic prolapse. Labour MP Emma Hardy, who called the debate, told MPs that the trials conducted before the introduction of mesh implants had been inadequate, and that pending a review of the evidence their use should be suspended.
Hardy and other MPs attending the debate said they had been contacted by countless constituents with harrowing stories of life-changing complications linked to mesh, and their struggles to be heard by the medical profession. Hardy urged the government to launch an independent inquiry into the “ongoing public health scandal” of serious complications suffered by many women who have been treated for urinary incontinence and pelvic prolapse.
“This is not an effort to scaremonger,” Hardy said.. Although the operation was usually a success, a recent study suggested 10% of women suffered significant complications, she told the debate. More than a dozen MPs relayed harrowing stories of constituents who had suffered life-changing complications linked to mesh, including perforated organs, chronic pain and loss of sex lives.
MPs also heard that there were more than 100 devices on the market in the UK, most of which had never undergone extensive clinical testing, and companies had withdrawn some devices without warning. Responding to the concerns, the health minister Jackie Doyle-Price announced that the publication of new guidance on the use of mesh by the National Institute for Health and Care Excellence (Nice) would be brought forward from 2019 to later this year. Doyle-Price said she had been “horrified” to hear that women had been given implants without being made aware of the risks.
“That many companies have already taken products off the market should tell us that there’s something not right with these devices,” Hardy said. But she dismissed the need for an inquiry and said the health regulator, the Medicines and Healthcare products Regulatory Agency, advised mesh was “still the best device for treating stress incontinence”.
The National Institute for Health and Care Excellence (Nice) is due to publish updated guidance on the use of mesh implants in January. NHS England said in a report in July that the treatment for urinary incontinence and prolapse was “a safe option for women”. However, since then further evidence has emerged about apparently high rates of complications. “The issue is not the product, but clinical practice,” she said . “That’s what’s going wrong.”
Earlier in the debate, other Conservative and DUP politicians had joined calls for tougher regulations on the use of the devices.
The Scottish Conservative politician, Paul Masterton, rejected the suggestion that there was insufficient evidence to warrant the reclassification of mesh as a higher risk device, pointing to “women who have lost their careers, their husbands, their homes, their dignity and their lives, who are forced to spend day after day and night after night in agony”. “They are the evidence,” he said.
Wollastonsaid she did not support a ban on mesh procedures, but argued these operations should be performed at specialist centres and highlighted “appalling failings” in the consent process and the lack of evidence.
“These products were marketed aggressively without adequate clinical trials,” she said. “We need to ensure there are proper clinical trials just as we would expect for medicine.”
Owen Smith, a Labour shadow cabinet minister, who chairs the all-party parliamentary group on surgical mesh implants, said mesh injury was “one of the worst medical issues” he had come across as an MP, and had sprung from a failure to test devices before launching them on to the market.
“This story is quite simple... If this was a medicine that was leading in one out of 10 cases to sexual dysfunction or losing the ability to walk or work, it wouldn’t be on the market,” he said. “That’s how we need to look at it.”
NHS England said in a report in July that the treatment for urinary incontinence and prolapse was “a safe option for women”. However, since then further evidence has emerged about apparently high rates of complications.
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.
MPs also heard that there are more than 100 devices currently on the market in the UK, most of which have never undergone extensive clinical testing, and which companies have withdrawn without warning.
Kath Sansom, a campaigner at Sling The Mesh, said: “People are waking up to the global scandal that is surgical mesh implants and at last it is on the political agenda at Westminster.”
Sohier Elneil, a consultant urogynaecological surgeon at University College Hospital, London, is calling for the use of mesh procedures for incontinence and prolapse to be stopped for two years. “The time has come for us to truly revisit everything we know about both these clinical states,” she said. “Clearly, the knowledge we have had to date has been limited both in scope and relevance. A change needs to happen now.”
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.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.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.
The Guardian revealed in August that thousands of women had undergone surgery to have vaginal mesh implants removed during the past decade. About one in 15 women fitted with the most common type of mesh support later required surgery to have it extracted due to complications.
Owen Smith, a Labour frontbencher who chairs the all-party parliamentary group on surgical mesh implants, said mesh injury was one of the worst medical issues he had come across as an MP, and it reflected a broader problem with weak regulation of medical devices.
“If this was a medicine that was leading in one out of 10 cases to sexual dysfunction or losing the ability to walk or work, it wouldn’t be on the market,” he said. “That’s how we need to look at it.”
Sarah Wollaston, the Conservative MP for Totnes, did not support the calls for a ban, arguing that for some women it could be the most appropriate and safest treatment option. However, she said there had been “clear failings” in the communication of risks and called for treatment to be moved to specialist centres.
“These products were marketed aggressively without adequate clinical trials,” Wollaston said. “We need to ensure there are proper clinical trials just as we would expect for medicine.”
Kath Sansom, a campaigner at Sling The Mesh, said: “People are waking up to the global scandal that is surgical mesh implants and at last it is on the political agenda at Westminster.”
Last week the health minister Jackie Doyle-Price told MPs she was aware that some women had suffered complications, but said it was “equally the case that many women also experience considerable relief from symptoms”.
Doyle-Price said: “I think it’s very important that the work that Nice are doing should be allowed to be undertaken so that we can actually make a very clear view of this.”
Sohier Elneil, a consultant uro-gynaecological surgeon at University College hospital, London, is calling for the use of mesh procedures for incontinence and prolapse to be stopped for two years.
“The time has come for us to truly revisit everything we know about both these clinical states,” she said. “Clearly, the knowledge we have had to date has been limited both in scope and relevance. A change needs to happen now.”