Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
MedSun: Newsletter #63, August 2011
FDA Safety Communication
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.
FDA Medical Devices: Products. UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. July 13, 2011.