The FDA has shown no signs or indications regarding any ban on transvaginal mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) with the news pouring in about a recommended ban requested by the National Institute for Health and Care Excellence (NICE) in the U.K.
NICE requested the ban indicated for the treatment of POP and not SUI and expects a virtual ban as the news spreads.
Although thousands of transvaginal lawsuits have been filed in the U.S. since 2008, with mixed verdicts announced for both parties, and manufacturers settling a significant number of claims, the FDA has no intention of considering a ban. The agency did reclassify the device in 2016 as a Class III (high risk) product for the treatment of POP, making them ineligible for the 510(k) clearance program.
