Skip to Content
Serving All of Western New York
Top

FDA Strengthens Requirements for Transvaginal Mesh Devices

Transvaginal Mesh
|

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

The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second-order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.

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

Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.

Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is 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.

Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.

Read the FDA's full news release here.

To contact us about a potential defective drug or medical device claim, please click here to complete an online intake form for a free consultation. 


Share To: