The Food and Drug Administration (FDA) has increased data requirements for surgical mesh used in the transvaginal treatment of pelvic organ prolapse (POP).
The FDA's mandate said the mesh devices must be reclassified as Class III devices, meaning they may carry a high risk. Additionally, manufacturers of the devices must now prove the safety and effectiveness of their products with a pre-market approval (PMA) application to the FDA.
The mesh devices were previously classified as low- to moderate-risk devices. Patients who have been treated with the devices have reported complications such as severe pelvic pain, organ perforation, infection, bleeding and painful intercourse.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, said. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”
Manufacturers of transvaginal mesh devices that are already on the market will have 30 months to submit PMAs. Any new devices must be approved after the submission of a PMA before they can be sold.
Surgical mesh has been used since the 1950s, first to repair abdominal hernias, and later for POP and transvaginal POP repair.
