The U.K.’s National Institute for Health and Care Excellence (NICE) is recommending a ban on transvaginal mesh devices used to treat women suffering from pelvic organ prolapse.
“The evidence for long term efficacy is inadequate in quality and quantity,” the group said in official guidance issued on December 15th. “Therefore, the procedure should only be used in the context of research.”
The document does not recommend a similar ban on transvaginal mesh implants indicated for the treatment of stress urinary incontinence.
Roughly 10,000 women in the U.K. undergo transvaginal mesh repair for incontinence or prolapse every year. An estimated 10-20 percent of recipients have suffered severe complications, including mesh erosion into the vaginal wall, organ damage, chronic pain, and pain during sexual intercourse.
The rate of transvaginal mesh complications is about 40 percent higher when the devices are used to treat prolapse compared to incontinence.
An investigative report that recently aired on the BBC’s Panorama program suggested that transvaginal mesh implants were inadequately tested prior to coming to market and poorly regulated. The broadcast also suggested that manufacturers had failed to warn doctors of their potential risks.
Even if the U.K.’s National Health Service declines to enact the NICE recommendations, many experts believe they will result in a virtual ban of the implants.
“The recommendations by Nice are highly significant, as I think they will make us all re-evaluate the way we use mesh,” Dr. Sohier Elneil, urogynaecologist, mesh expert and former board member at NICE, told Sky News.
“I think there will be a snowball effect because people will look very carefully at the product per se rather than the application, because we know the product has its own problems; it’s a foreign substance and obviously reacts with the tissue around it.”
The U.S. Food & Drug Administration (FDA) estimates that more than 100,000 women in this country undergo prolapse repair with transvaginal mesh, while 208,000 women receive the devices to treat stress urinary incontinence.
The FDA began reviewing the devices in 2008, amid an increasing number of reports linking the products to serious and life-changing complications. In July 2011, the FDA warned that transvaginal mesh complications associated with prolapse repair were not rare, a change from its previous position on the issue.
“Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk,” the agency said at the time.
In 2016, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the implants ineligible for the agency’s 510(k) clearance program. However, the agency is not currently considering a transvaginal mesh ban.
Since 2008, tens of thousands of U.S. women have filed transvaginal mesh lawsuits accusing device manufacturers of failing to adequately test their implants or provide doctors and patients with adequate warnings of their risks.
Numerous transvaginal mesh trials have been convened in the ensuing 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.