The U.S. Food and Drug Administration (FDA) is enforcing stricter regulations for surgical mesh products used in transvaginal procedures to repair pelvic organ prolapse (POP). The products are being reclassified from moderate risk (class II) to high risk (class III) when used transvaginally.
The stricter regulations do not apply to surgical mesh for other indications, such as stress urinary incontinence or abdominal repair of POP.
The FDA now requires all manufacturers of mesh products to submit data that supports the effectiveness and safety of the devices. Manufacturers with products currently on the market will have 30 months to comply with the new requirements.
According to the FDA, a significant increase has occurred over the past several years in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, such as severe pelvic pain, infection, and organ perforation.
In 2011, an advisory panel of experts recommended that more data was needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.