Coloplast Responds to FDA’s Decision to Remove Surgical Transvaginal Mesh as Treatment Option for Pelvic Organ Prolapse
Coloplast was informed by the FDA that the PMA for Restorelle DirectFix Anterior is not approved and the company must cease marketing and distribution immediately. As a result, FDA regulations require that all anterior transvaginal synthetic mesh products, including Coloplast’s Restorelle DirectFix Anterior device, can no longer be commercialized in the U.S., effective immediately. Coloplast …