Urogynecologic Surgical Mesh Implants - Update
MedSun: Newsletter #69, February 2012
FDA Medical Device Safety
Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III. The FDA also continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through a variety of methods.
FDA Medical Device Safety. Urogynecologic Surgical Mesh Implants – Update. January 4, 2012.