In light of safety and effectiveness concerns, as well as reports of serious complications arising from the use of transvaginal surgical mesh (TVM) to treat pelvic organ prolapse, the U.S. Food & Drug Administration issued two proposed orders on April 29, 2014 to reclassify TVM as a high-risk Class III device.
In a written release, Dr. William Maisel, Deputy Director of Science and Chief Scientist with the FDA’s Center for Devices & Radiological Health, indicated, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) and is now proposing to address those risks for more safe and effective products. If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
Although not life-threatening, POP occurs when the bladder, uterus, bowel, and other structures that support pelvic organs weaken or fail, causing those organs to drop and protrude into the vagina. Surgical mesh has been used to reinforce the weakened or damaged tissue, but has been identified as causing pelvic injuries, including severe pelvic pain, erosion of the mesh into adjacent pelvic organs, and painful sexual intercourse. Tens of thousands of lawsuits have been filed against TVM manufacturers such as American Medical, Johnson & Johnson’s Ethicon division, and C.R. Bard, alleging that they marketed defective devices.
The FDA’s safety efforts began in earnest in July 2011 when the agency issued communications about serious complications resulting from TVM implantation in the treatment of POP, and released scientific literature documenting the basis for those concerns. The FDA later recommended the Class III reclassification, which would require manufacturers to conduct post-market surveillance studies, leading up to the April 2014 proposed orders.
If you or someone you care about has suffered as the result of a TVM implant or other defective device, please contact the attorneys at Sommers Schwartz today – we’re here to help.