Patients cry “whitewash” as NHS refuses to halt use of mesh implantsBMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3603 (Published 26 July 2017) Cite this as: BMJ 2017;358:j3603
An NHS review of transvaginal mesh implants released this week has been branded a “whitewash” after failing to order a safety review of the devices, which patients say carry unacceptable risks of severe and life altering side effects.
The review, led by NHS England, looked at the use of implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP)—surgery carried out in about 15 000 women every year in England.1
An emotionally charged meeting in parliament last week heard testimonies from a dozen women on how mesh had left them disabled, in chronic and debilitating pain, needing bladders and bowels removed where the mesh had shrunk and sliced into them, unable to have sex, or with psychological problems.2
The implants are subject to an ongoing inquiry in Scotland, where the use of mesh for POP is suspended and where around 420 patients are involved in civil litigation against manufacturers and health boards.3 In the United States hundreds of thousands of women are taking action against manufacturers, and some £1.5bn has already been paid in compensation.
NHS England’s report acknowledged that collection of data on complications from mesh implants had been “insufficient.” But it noted “significant progress” since an interim report in 2015, such as increased reporting of complications, better informed decision making, and improved care for the women affected. It concluded, however, that women should not be denied “effective surgical options because there is some degree of risk.”
Kath Sansom, a mesh recipient who set up a campaign involving more than 2000 affected patients, called the report a whitewash.
“No patients were invited to the review meetings for the last 18 months, and there is no acknowledgment here of how many lives have been catastrophically destroyed by these devices,” she said. “We need a suspension of mesh while we gather up non-biased studies, sort out problems with hospital coding so we know the extent of this problem, and [have] a full safety review of mesh. We need a national database and mandatory reporting by surgeons.”
Sansom added, “There are black holes in data collection, little monitoring of patient outcomes, and a medical device regulatory system so weak that in the last five years we have witnessed the PIP breast implant scandal, the metal hip scandal, and now mesh—all under the nose of the MHRA [Medicines and Healthcare Products Regulatory Agency] that is supposed to be a watchdog for the NHS.”
John Wilkinson, director of devices at MHRA, said, “What we continue to see is that evidence supports the use of these devices for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances. We are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.”
Adverse incident reports to the MHRA relating to mesh implants for SUI have risen from 38 to 171 a year during 2011-16 and from 13 reports to 54 reports during the same period for POP.
Jonathan Duckett, vice chair of the British Society of Urogynaecology, said, “We will continue to promote the [society’s] database to clinicians as a way of collecting more data that tells us about complications.”
Owen Smith, a shadow cabinet member and organiser of the parliamentary meeting, believes that the use of mesh implants in women is a scandal on the scale of the thalidomide disaster of the 1960s, saying that patients would be “deeply disappointed.”
“This was an opportunity for the NHS to take a lead and recommend a pause in the use of mesh until we know precisely how many women have been adversely affected by the product,” he told The BMJ. “The only people pleased with this report will be the medical device companies who marketed mesh so diligently and who now fear mass litigation.
“Many companies have already taken their mesh products off the market, and that alone should tell us that something is not right.”