Senior doctors have called for a public inquiry into the use of vaginal mesh surgery amid mounting concerns that a significant proportion of patients have been left with traumatic complications.
Speaking at a meeting in parliament, Carl Heneghan, professor of evidence-based medicine at the University of Oxford, drew comparisons with the thalidomide scandal, saying that there was evidence that mesh procedures, used to treat complications from childbirth, carry significantly more risk than official figures suggest.
“With thalidomide you could see the visual representation. [With mesh] you can’t see it,” Heneghan told the meeting. “We should have a public inquiry.”
Between 2007 and 2016, more than 126,000 women in England were treated with mesh implants, tapes and slings, for urinary incontinence and organ prolapse, according to figures obtained by the Guardian.
The procedures involve inserting a plastic mesh into the vagina to support the bladder, womb or bowel. In the majority of cases these operations are quick and successful.
However, speaking at the meeting in parliament, Heneghan and Sohier Elneil, a consultant urogynaecologist at University College Hospital, said that complication rates for some types of procedure appeared to be unacceptably high, and raised questions about whether the surgery was being used inappropriately.
Elneil said that unpublished research by her team, based on Hospital Episode Statistics, suggest that urinary incontinence surgery has a readmission rate of 8.9% and that most of these patients required some form of subsequent procedure. “These are not minor complications,” she said.
By contrast, a report by the Medicines and Healthcare Products Regulatory Agency (MHRA), the government watchdog, suggested a roughly 1-2% rate of pain or “erosion” for mesh procedures related to incontinence.
Heneghan cited a recent Lancet study, which showed that the readmission rate for one form of mesh surgery for prolapse was 19% – although the figure varied depending on the type of procedure.
The meeting came as a group of patients in the UK are preparing a class action against manufacturers. David Golten, a partner at Wedlake Bell LLP, claims his firm is already representing 200 women. Previously, there have been huge payouts linked to lawsuits in the US and a major trial against Johnson & Johnson began in Australia last week.
The meeting also heard a series of harrowing testimonies from patients who had experienced life-altering complications due to surgery.
Karen Preater, 40, from Rhyl, described how she was left with intense pain after having mesh surgery to treat incontinence. “My kids don’t remember the mum from three and a half years ago. I don’t do the things I used to do,” she said. “I can categorically say, if I didn’t have my children I wouldn’t be here today.”
Carol Williams, 58, also from North Wales, broke down in tears as she told the meeting how she had been admitted to the Priory clinic after becoming suicidal due to an escalating series of complications brought about by her surgery for pelvic prolapse.
Others spoke of “cheese wire” pain, removal of organs that had become ensnared in the mesh, loss of their sex lives and the psychological toll of not being listened to by their doctors. One women said she was being treated for post-traumatic stress disorder “like a soldier coming back from Afghanistan”.
In some cases, the patients had opted for what they said was presented as a “quick fix” to treat problems that were annoying but not debilitating, such as mild urinary incontinence.
John Osborne, a retired gynaecologist, said that when the procedure was introduced in the 1990s, it was used far too liberally, in the absence of good evidence on the risks.
“Surgeons were saying ‘no problem, I can fix you up with a little mesh’,” he said. “The mesh was being put in too many people, too easily. I’m not saying that mesh should be totally banned, but not used in the numbers that it has been.”
If problems occur, having the procedure reversed is a complex and risky procedure because the mesh, which is designed to be permanent, becomes embedded in the surrounding tissue. Kath Sansom, founder of Sling the Mesh campaign, described this as like “trying to remove chewing gum from matted hair”.
The meeting in parliament was organised by Owen Smith, the Labour MP for Pontypridd, and Sling the Mesh, a campaign group that is calling for the procedure to be banned.
However, other doctors have cautioned that problems have arisen mostly due to aggressive marketing of substandard products by companies and, in some cases, inadequate training on the part of doctors.
Mark Slack, a consultant gynaecologist at Addenbrookes Hospital in Cambridge, said: “The TVT [the most common mesh procedure] is a good operation if done by the right people by the right indications,” he said.
“We now for the first time have masses of patients coming in and saying ‘You’re not going to put mesh in me are you?’” he added. “There’s a danger of creating a massive problem.”
Alternative treatments for incontinence and prolapse also carry risks, he said – and in some cases the complication rates could be worse.
In a statement, the MHRA said: “Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.
“We are committed to help address the serious concerns raised by some patients. We have undertaken a great deal of work to continuously assess findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.
“What we continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse, in appropriate circumstances. This is supported by the greater proportion of the clinical community and patients.
“In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.”