FDA Advisory Panel Calls for Change to Class III Category for Vaginal Mesh

On September 9, 2011, a FDA advisory panel called for more clinical studies and tougher regulation of certain surgical mesh products used to treat POP. The FDA is proposing that mesh products that are inserted through the vagina be moved to the highest-risk, Class III FDA category of medical devices. This requires companies to conduct clinical trials on people and then submit an application seeking FDA approval, similar to the mechanism required for drugs.

Modern Medicine reported, "Denise Elser, MD, during the public hearing section on behalf of the American College of Obstetricians and Gynecologists, stated that, 'Patients don't care about POP Q measurements; they care about feeling a bulge.'"

While FDA deputy director of science for the agency’s device-approval center, William Maisel, told Bloomberg that, "'We believe there are certain uses of mesh where we need additional data to help guide the clinical community. Our goal is to make sure the right women use it at the right time.'"

Learn more about our firm's investigation by visiting our transvaginal mesh page.

By Wendy Fleishman