Regulators in the U.K. have effectively banned the use of transvaginal mesh in hospitals run by the National Health Services (NHS) in an effort to lessen the risk “life-changing and life-threatening injuries” to women.
According to The Guardian, the country’s government has accepted that use of the implants to treat complications – including pelvic organ prolapse and stress urinary incontinence – that many women experience after childbirth, should be suspended immediately.
The decision is a major victory for patient advocates who have been working to ban transvaginal mesh since the devices first attracted scrutiny a decade ago. It follows a government-ordered independent review that commenced in February 2017, which concluded that transvaginal mesh surgeries should cease until steps are implemented to mitigate risks associated devices.
“I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly,” Julia Cumberlege, who chaired the review, said in a statement to The Guardian. “Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now.”
The move will end nearly all transvaginal mesh surgeries in NHS hospitals for the time being. However, implants will still be available as a last resort for certain “carefully selected patients.”
The NHS ban could be lifted if certain steps are taken by March 2019, including the establishment of a registry to track transvaginal mesh surgeries and complications.
Concerns over transvaginal mesh have been building since 2008. That year, the U.S. Food & Drug Administration (FDA) issued a public alert warning that the devices had been associated with more than 1,000 reports of mesh erosion, organ damage, chronic pain and other life-changing complications.
The FDA updated its warning in 2011, after the number of transvaginal mesh complications reported to the agency tripled. The regulator also warned that injuries following prolapse repair surgery with transvaginal mesh were not rare, a reversal of the position it had taken in 2008.
Most recently, the FDA reclassified transvaginal mesh indicated for pelvic organ prolapse surgery as high-risk medical devices. Among other things, the reclassification prevents such implants from obtaining regulatory clearance through the agency’s 510(k) program, which does not require a new medical product to undergo human clinical trials before coming to market if a manufacturer can show that it is “substantially equivalent” to a previously-approved device.
Since 2008, more than 100,000 plaintiffs have filed transvaginal mesh lawsuits in courts throughout the United States in a bid to obtain compensation for life-changing injuries and complications they claim were the result of defectively designed device.
Numerous cases have already gone to trial, with some juries awarding multi-million verdicts to plaintiffs. Several manufacturers have also agreed to settle hundreds of transvaginal mesh lawsuits.