Vaginal mesh study reveals how lax medical regulation puts women at risk

Sixty-one mesh devices went to market based on "equivalence" to an older existing product, despite being made of different materials and without new evidence of their safety

Campaigners want a public inquiry into the complications and continued use of vaginal mesh implants

Failures in the regulation of vaginal mesh implants put women at risk of serious infection and chronic pain, experts have said.

Researchers found that lax rules on medical devices, which allow products to be approved on an “equivalence” basis if they’re similar to an already approved device, allowed 61 mesh implants to be marketed based on evidence for two older products.

While regulators have plans in place to tighten up oversight, including requiring clinical trials for each medical device in line with drug approval, these will not be fully in place until 2020.

The academics from Oxford University argue that a public registry for all invasive medical devices should be established to allow long-term follow up with patients to assure device safety.

The unfolding scandal around transvaginal mesh implants (TVM) has been branded the most serious women’s health failing since thalidomide.

Vaginal mesh implants are given to around 15,000 women every year to tackle complications following childbirth like urinary incontinence and prolapse – where the weakened pelvic muscles mean the organs can bulge into the vagina.

More than 100,000 women in the US are involved in a class action lawsuit with manufacturers after suffering complications, and legal proceedings in the UK involve around 500 hundred women with 2,000 set to join.

Complications are relatively rare, but independent academics say they are more common with the mesh implants for treating prolapse and surgical repair is likely to be more effective.

The authors report that, of the 110 formally reported, mesh-related “adverse incidents” recorded by the UK’s medical device watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), since 2005, 65 were for the device breaking off into vagina, 21 related to infections, 39 related to pain and 16 related to organ perforation.

The Independent has followed the growing public outcry on mesh implants in the wake of the Government’s refusal to ban the devices or launch a public inquiry into their use following a national report on the issue.

This week has also seen the first reported death as a result of a TVM device.

Canadian mother and mesh campaigner Chrissy Brajcic died after developing an antibiotic-resistant infection from her implant.

The paper, published in the BMJ Open today, used data for devices approved by the US Food and Drug Administration.

In an analysis, the authors said: “We traced marketing clearance for 61 mesh devices back through a chain of equivalence claims to only two unique originating devices approved in 1985 and 1996.

“We found no evidence of any new clinical trial data at the time of device approval for all of these 61 devices, with empirical evidence of effectiveness from randomised trials emerging on average five years after approval.”

It warns that this “family tree” of equivalence approvals meant devices with different designs were put on the market without safety evidence, and when the changes should have alerted regulators that equivalence wasn’t applicable.

The authors warned that in Europe devices can also be approved on equivalence grounds, with approval granted by centres across the European Union.

But, unlike the US applications, EU approvals are not public, making them “impossible to scrutinise”.

The study’s lead author said he hoped that after Brexit the UK would have a more rigorous approach that incentivised evidence backed devices and put “patient safety first”.

Professor Carl Heneghan at Oxford University’s Centre for Evidence Based Medicine said patients might wait longer for treatments and companies might “lose market share”, but added: “We could, and should though, lead the way by having regulatory systems that incentivise the production of high-quality evidence at the time of approval for implantable devices – those deemed to be the riskiest.

“In particular ensuring those devices that do make a difference and are safe are made available. And for those that aren’t safe, ensuring they do not make it onto the market in the first place.”

Later this month, England’s National Institute for Health and Care Excellence (Nice) will publish final guidance on the devices.

The watchdog could either say the devices are no longer recommended for use; that they should only be used for research purposes; or they should only be used when clinicians have had certain conversations with prospective patients about possible side-effects or complications.

Independent academics backed the plan for a registry and “tightening” regulation, especially as implanted devices are often life-long.

Professor Cathryn Glazener, retired emeritus professor at the Health Services Research Unit, University of Aberdeen, did not contribute to the paper and flagged that the BMJ paper didn't appear to account for safer, and more effective, mesh implants for incontinence.

But she added: “I do agree with the authors of the article, however, that regulation of new device use needs to be tightened up, in line with the much more rigorous scrutiny already in place for new drugs.”

The MHRA, which continues to recommend mesh devices, citing “insufficient evidence” of widespread complications for a ban, said it is part of a group looking at such a registry and encouraged women to report any complications.

John Wilkinson, MHRA director of devices said: “Patient safety is our highest priority and we recognise some women do develop serious complications which can be very significant for the affected women.

“We also know many women gain benefit from these surgical procedures for what can be extremely debilitating conditions.”

“We continue to work closely with NHS England, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications. "

Additional reporting by PA