FDA strengthens requirements for surgical mesh for transvaginal repair of pelvic organ prolapse

Editor's Note

The Food and Drug Administration (FDA) on January 4 issued two final orders to strengthen the requirements for surgical mesh to repair pelvic organ prolapse tranvaginally.

One order reclassifies surgical mesh from class II (moderate risk) to a class III (high-risk) device.

The second order requires manufacturers to submit a premarket approval application to support the safety and effectiveness of surgical mesh for the transvaginal repair of pelvic organ prolapse.

These orders do not apply to surgical mesh for other indications.

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina.