FDA issues safety orders for surgical mesh to repair pelvic organ prolapse

The FDA has issued two orders that will require manufacturers of surgical mesh used for the transvaginal repair of pelvic organ prolapse to address safety concerns, according to a press release from the agency.

As a result of the orders, transvaginal mesh will be reclassified as a class III medical device from class II, indicating that it is a higher-risk device. Additionally, manufacturers will be required to submit a premarket approval application demonstrating safety and efficacy.

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, said in the release. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

The agency reported that the number of adverse events in using the device, such as severe pelvic pain and organ perforation, have significantly increased in the past several years. An advisory panel recommended that more data be collected to determine safety.

Manufacturers that have devices on the market will have 30 months to submit a premarket approval, according to the FDA. Manufacturers that plan to put new devices on the market must submit a premarket approval before marketing approval.

The FDA noted that its orders are only applicable to surgical mesh devices that are marketed for the transvaginal repair of pelvic organ prolapse. It is not applicable to surgical mesh used for stress urinary incontinence, abdominal repair or pelvic organ prolapse or other indications.