A leading health watchdog will soon call for a virtual ban on transvaginal mesh implants intended to treat women suffering from pelvic organ prolapse.
According to the BBC, draft guidance from U.K.’s National Institute for Health and Care Excellence (NICE) will also recommended that the controversial devices only be used for research purposes.
It is expected that the NICE guidance will be finalized and issued next month. At least one expert told the BBC that the U.K.’s National Health System (NHS) will likely implement the recommendations, though it is not required to do so.
Per the BBC, the draft guidance cites “serious but well-recognized safety concerns” associated with the use of transvaginal mesh, as well as a lack of “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity”. While most patients who underwent prolapse repair with mesh reported satisfaction with the procedure, the NICE document points out that transvaginal mesh complications can “have life-changing consequences” when they occur.
More than 92,000 women in the U.K. received vaginal mesh implants between 2007 and 2015. Data suggests that 1 in 11 experiences complications.
University of Oxford Professor Carl Heneghan called transvaginal mesh a “health catastrophe,” telling the BBC that the NICE recommendations were a signal that U.K. health regulators “had got this wrong.”
“Seven years I have been watching this emerge – it is absolutely farcical how bad it is,” he said. “Either they’re burying their heads in the sand or they don’t know what they’re doing.”
Transvaginal mesh, which is indicated to treat women suffering from pelvic organ prolapse and stress urinary incontinence, has been at the center of a similar controversy in this country. The U.S. Food & Drug Administration (FDA) cleared these implants via its 510(K) program, which allows a new device to come to market without first undergoing human clinical trials, as long as manufacturer can demonstrate that it is “substantially equivalent” to another device already on the market.
When the FDA issued its first transvaginal mesh warning in 2008, its database had already received more than 1,000 serious injury reports associated with the devices. Three years later, the agency renewed its warning, after the number of reported injuries tripled. The FDA’s second alert also suggested that transvaginal mesh offered no additional benefits over traditional non-mesh methods of prolapse repair.
Hundreds of thousands of U.S. women have since filed transvaginal mesh lawsuits against the companies that market these implants, including American Medical Systems, Boston Scientific Corp., C.R. Bard, Inc., and Johnson & Johnson’s Ethicon, Inc. subsidiary. Plaintiffs claim that these and other defendants did not subject their transvaginal mesh devices to adequate testing prior to bringing the implants to market and failed to properly apprise doctors and patients of the risks associated with their use.
Numerous vaginal mesh lawsuits have gone to trial in recent years, with juries delivering verdicts for both plaintiffs and defendants. A significant percentage of claims have also been settled, though thousands remain pending in federal and state courts throughout the country.