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FDA Proposes New Regulations on Surgical Mesh

By July 29, 2014Product Liability

On April 29, the Food and Drug Administration proposed strict new regulations designed to address the problems associated with transvaginal mesh (TVM) products. Vaginal mesh has been widely used as a method of treating pelvic organ prolapse (POP) as well as treating stress urinary incontinence (SUI).  Unfortunately, the mesh causes serious complications and there are currently thousands of lawsuits pending against major mesh manufacturers.   The FDA has finally proposed to take definitive action to stop more women from being harmed.

The FDA’s proposed regulations would involve reclassifying surgical mesh as a “high-risk” product. Mesh devices are currently in the moderate risk category, which does not reflect the significant complications that women have had. While making this change could cause doctors and patients to look more carefully at whether mesh should be used and could require manufacturers to be more careful, unfortunately it comes too late for many women who are already experiencing significant harm from defective mesh devices.  An experienced defective product lawyer at Carey, Danis & Lowe should be consulted by victims of vaginal mesh complications for information about filing a claim for damages against mesh manufacturers.

FDA Proposes Action on Surgical Mesh

Most transvaginal mesh products were released onto the market by manufacturers with limited pre-market testing under special 501(K) clearance rules. The vaginal mesh products soon began to cause serious complications. The mesh could erode, causing significant pain for women.  Vaginal bleeding, infection, pain, discomfort during intercourse, and even perforation of internal organs were all possible side effects that were common for women who had mesh implanted.  Surgical removal of the mesh was frequently the only solution for patients who were suffering, and removal could be very difficult so multiple surgeries were often necessary.

In response to the thousands of complaints, the FDA ordered post-market surveillance studies of vaginal mesh products back in January of 2012. Manufacturers were required to complete these studies to address specific health concerns.   The FDA also issued public safety communications both in October of 2008 and in July of 2011, warning of the use of vaginal mesh as a treatment method.

Despite these concerns,  and despite a recommendation in September of 2011 from the FDA’s Obstetrics and Gynecology Device panel, the FDA failed to move to reclassify vaginal mesh until the April 29, 2014 proposal reported on by WBUR.  If vaginal mesh devices are reclassified, manufacturers will be required to submit premarket approval applications.

It is well past time for this change to be made. From 2011 to 2014, many women may have had mesh implanted before the FDA’s proposed rule change, leading to needless suffering. Victims of vaginal mesh complications can pursue damage claims to recover compensation for medical expenses, pain and suffering and other losses. Carey, Danis & Lowe can help, so call today to speak with a St. Louis defective medical device lawyer.