FDA Now Moves to Reclassify Transvaginal Mesh Kits as High Risk
Austin, TX (Law Firm Newswire) July 14, 2014 – The FDA has announced new regulations pertaining to surgical mesh used in transvaginal surgery to repair pelvic organ prolapse.
“The new regulations are supposed to impose greater levels of scrutiny on such products and mandate that manufacturers submit a pre-market approval application to have their product evaluated. Prior to issuing these new regulations, the transvaginal mesh kit was rated as being a moderate risk device. However, in the face of thousands of lawsuits against various mesh makers, the FDA had to move to do something. Because the mesh was rated as a moderate risk, there was no requirement to conduct human clinical trials before marketing it,” explains Bobby Lee, a personal injury lawyer with Lee, Gober and Reyna in Austin.
The move to reclassify the transvaginal mesh products as high-risk means any further mesh products would not be marketed without trials and that if current mesh makers intend to keep selling their products, they must conduct safety studies. “While this is good news, it is a bit like closing the barn door after the horse has escaped. Testing existing products in light of the thousands of lawsuits for defective surgical mesh would seem to be redundant since it was inappropriately tested in a live, unsuspecting market over the last few years, with disastrous consequences,” points out Lee. “Clearly, settling the large number of lawsuits relating to defective mesh products may take many years.”
Recent court documents indicate there are over 50,000 transvaginal mesh lawsuits filed in the U.S. District Court, Southern District of West Virginia by women allegedly injured by mesh products.
The lawsuits are:
· In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)
· In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387)
· In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2187)
· In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326)
· In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation – MDL No. 2327)
· In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)