Testimony Before the FDA’s Obstetrics and Gynecology Devices Panel Regarding Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse

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In testimony before the Food and Drug Administration’s (FDA’s) Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, Public Citizen urged the FDA to reject the premarket approval applications for the three mesh products for transvaginal repair of pelvic organ prolapse (POP) that are still on the market because these devices offer no clinically significant benefits in comparison with non-mesh repair of POP and have high rates of serious complications. Surgical mesh for transvaginal POP repair is a quintessential example of the fundamental deficiencies in the FDA’s oversight of medical devices, particularly those that are permanently implanted.

See Public Citizen’s other work on surgical mesh for transvaginal repair of pelvic organ prolapse.