An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.
Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, “unlike in the Thalidomide scandal, you are unable to see the extent of the women’s injuries”.
Speaking about the scale of the scandal, he said: “I think this is the worst one that we’ll ever see in my lifetime because of the scale of the number of women affected.”
More than 75,000 women in England had the procedure – known as TVT – between 2006 and 2016, according to NHS data.
One in 15 have had the implant removed.
The 20-minute operation is used to treat stress incontinence and also prolapse, mainly caused after childbirth, by inserting a plastic mesh, made out of polypropylene, into the vagina to support the bladder.
While for many the procedure can be quick and successful, for others it can have dire consequences, leaving patients in chronic pain and unable to walk, work and have sex.
The mesh is supposed to be flexible, but when inside the body can stiffen, erode and slice through organs, including the bladder.
Lesley Elder, 49, had the mesh fitted in 2010 after having two children, and has had 13 subsequent operations to repair the catastrophic damage.
She is now registered disabled, is in chronic pain and survives on benefits.
“I’m not the woman I used to be,” she told Sky News. “I feel like a helpless no-hoper. I think I’d be better off dead; I don’t want to live like this. I want my old life back.”
Professor Heneghan, from the University of Oxford, said Lesley’s case is not unique, and warned that the UK is heading for a “major disaster”.
“Every young woman I have talked to has not been told about the adverse consequences,” he told Sky News.
Professor Heneghan said the NHS was not offering the operation to patients based on “need” but on what manufacturers with a commercial interest wanted.
The mentality, he said, was: “Get people through the system – in and out.”
One manufacturer of TVT is Ethicon, a subsidiary of Johnson & Johnson.
Up to 300 women in the UK are taking part in legal action against Johnson & Johnson, claiming the implants they were fitted with are not fit for purpose.
David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, said it was a “significant” medical case.
Total compensation, he claimed, could “run into the billions of pounds, which would make it the largest medical case in UK history”.
A spokesperson for Johnson & Johnson told Sky News implantable mesh was “backed by years of clinical research” and that “Ethicon is confident in its products”.
They said the use of pelvic mesh devices is “supported by medical experts around the world”.
The spokesperson added: “Ethicon is defending lawsuits concerning the use of our pelvic mesh products.
“We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products.”