Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Meeting on September 9, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)

Agenda: On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency’s proposed premarket and postmarket regulatory strategies for these devices, including reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.