FDA May Reclassify Transvaginal Mesh as “High Risk” Class III Medical DeviceJanuary 6, 2012 — The U.S. Food and Drug Administration announced that it would be considering a recommendation to reclassify transvaginal mesh and surgical mesh as a “high-risk” medical device, elevating it from Class II to Class III. The FDA has also ordered manufacturers to complete postmarket studies. If you have suffered a serious complication… Read More









