FDA Proposes Strict Guidelines for Transvaginal Mesh Devices | Karl Truman Law Office

April 30, 2014

Yesterday, the US Food and Drug Administration proposed two orders that are aimed at addressing the health risks associated with transvaginal mesh used for pelvic organ prolapse (POP). Tens of thousands of lawsuits are pending against pelvic mesh manufacturers, alleging serious injuries and complications.

According to the FDA news release, the orders propose for transvaginal mesh used for POP to be reclassified as a high-risk device. Currently, surgical mesh used for POP is classified as moderate risk. These orders would also require manufacturers of surgical mesh for POP to submit proof of safety and effectiveness before the device can go to market.

Some people believe the transvaginal mesh devices used for POP were rushed to the market too hastily. Under a certain FDA rule, if a new medical device is highly similar to an already approved device, then that new device can undergo a fast-track approval process. Mesh used for POP was put on this fast-track because it was deemed as being substantially similar to surgical mesh used for treating urinary incontinence and other problems.

Over the last several years, reports of serious mesh complications have been mounting. Such complications include mesh migration and erosion. Women have reported infection, pain and bleeding among other side effects. About three years ago, the FDA had found that mesh used for pelvic organ prolapse caused more complications than the traditional surgery used to repair the condition.