The UK government has refused to hold a public inquiry into the use of vaginal mesh implants which medical experts have described as a health scandal worse than thalidomide.
Sky News reports that Labour MPs joined the calls of thousands of mesh-injured women to suspend mesh procedures, which are used to treat urinary incontinence and prolapse, and review the evidence on their safety. But Health Minister Jackie Doyle-Price said the priority is to look into the treatment of women and the recording of complications. She also announced that an update to national clinical guidelines by the National Institute for Health and Care Excellence on the use of vaginal mesh will be brought forward and be published by the end of the year, 18 months earlier than planned.
The report says her decision was met with gasps from women listening to a debate in Parliament – and shock from fellow MPs. Labour MP Emma Hardy said the minister's "reaction" was "simply not good enough", adding that she and others would "keep pushing" until they got a "much more satisfactory answer". Earlier, the Labour Party said it was backing a call for a public inquiry into the procedure, and called for products to be stopped immediately in England while it was ongoing.
Thousands of women have said the implants have perforated organs, caused chronic pain and left them unable to work or have sex, the report says. Around 15,000 women every year have the operation, which involves inserting a plastic tape through the vagina and around the urethra to support the bladder. The official complication rate for mesh procedures is 1-3%, yet, the report says, latest hospital figures show that it is higher, with almost 10% of women suffering adverse effects.
Uro-gynaecologist Sohier Elneil says one of the key problems with mesh is that it can change once inside the body. It can become brittle, erode and slice through organs like the bladder. "It's a huge problem," Elneil said. "I think it's bigger than Thalidomide, because the numbers of those affected are much more. And if we look at the problem globally then it's worse than the metal-on-metal hips and the PIP scandal as well."
The report says Elneil is one of few surgeons trained to remove mesh implants, a highly dangerous operation as the implants are designed to be permanent. She says she used to see one or two women a month but now treats up to eight every week.
She said: "In England there's been this feeling that the number of women affected wasn't that great but not everyone was submitting their data, so there was very minimal information to make a decision on. Now with the latest reports, quite clearly this is a game changer and the procedure needs to be re-evaluated."
The report says UK journalist Kath Sansom had a mesh implant fitted to treat mild incontinence caused by childbirth. After suffering chronic pain, she started a campaign Sling the Mesh to provide support for others and call for the suspension of mesh implants to bring England in line with Scotland, where they were suspended in 2014. The campaign group now has more than 3,000 members.
She said: "The medical professionals are all very good at denying there's a problem or saying you are a mystery patient. There is also an element of misogyny whereby your pain is belittled because, to look at us women, none of us look ill or in pain. The damage is hidden. This makes it easier to be shuffled off into a corner and ignored.’
The report notes that as first reported two years ago, for many patients the procedure can be quick and successful but thousands have suffered debilitating conditions, are on daily medication and some now struggle to walk. But there's another issue Sansom says is rarely discussed – the effect mesh has on a woman's sex life. For hundreds of women they say the pain they suffer makes having sexual intercourse impossible.
She said: "The impact on women is so devastating. It's such a personal thing and anyone in a healthy relationship will want an intimate relationship and when that is taken away it robs them of a massive part of being a couple and puts a huge strain on relationships and family life. It's so cruel."
The report says NHS England and various clinical bodies, including the Royal College of Obstetricians and Gynaecologists, maintain that, for many patients, mesh is a safe and effective option that greatly helps with conditions which can be distressing for those affected. They support the view of the official regulator of mesh, the Medicines and Healthcare products and Regulatory Agency (MHRA), which says there's not enough evidence to justify a ban.
The MHRA's director of devices John Wilkinson said: "There is no regulatory reason to take the product off the market because if it is used in the right circumstances with the right patients appropriately consented and aware of the risks then we have no evidence that the product should be taken off the market."
The report says, howeve, that vaginal mesh implants are the subject of huge litigation. Across the world more than 55,000 women are suing one manufacturer of mesh, Johnson and Johnson. In the UK, pressure is also mounting, with 400 women taking legal action against the pharmaceutical giant in what lawyers say could become the biggest medical case in UK history.
In a statement, Ethicon, the sister company of Johnson and Johnson which makes mesh products in the UK, is quoted in the report as saying: "Ethicon is confident in the positive impact our pelvic mesh products have had on the vast majority of women who have chosen this treatment option. We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."
[link url="http://news.sky.com/story/vaginal-mesh-public-inquiry-turned-down-by-government-11086074"]Sky News report[/link]
[link url="http://news.sky.com/story/journalist-kath-sansom-was-wreck-after-vaginal-mesh-implant-11086123"]Kath Sampson's comment[/link]