FDA strengthens requirements for surgical mesh for the transvaginal repair of POP

["FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA strengthens requirements for surgical mesh for the transvaginal repair of POP

	January 2016 www.fda.gov/womens FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks 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. 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. Read the Press Release Learn More about Urogynecologic Surgical Mesh Implants Recommendations for Patients Please share this update with your network, members, constituents, and community. FDA Office of Women’s Health 10903 New Hampshire Avenue WO32 - Room 2333 Silver Spring, MD 20993-0002 301-796-9440

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