Woman Who Experienced Transvaginal Mesh Complications Questioned FDA. Research published in Obstetrics and Gynecology on May 4, 2016 by Northwestern University criticizes the agency for approving a number of high-risk women’s health devices based on weak clinical studies, including transvaginal mesh.
Lead researcher Dr. Steve Xu said, “Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with transvaginal mesh, it may have provided earlier warning of patient safety risks.” Now, women who have experienced transvaginal mesh complications question why the U.S. Food and Drug Administration (FDA) took so long to classify the mesh as a high-risk medical device.
According to the FDA website, the agency claimed the current mesh product was similar to older mesh products and was cleared under the fast-track process, allowing transvaginal mesh to be cleared as a safe and effective device. Meanwhile, it took the FDA until the beginning of 2016 to classify the transvaginal mesh as a Class III, or high-risk medical device, which mandates a more stringent clearance process involving clinical trials.
Device Regulation Is So Much Weaker Than Drug Regulation
The Northwestern University researchers studied 18 high-risk devices that were approved between 2000 and 2015. Of those, four did not demonstrate effectiveness, six were not require to post-marketing safety studies, and three were withdrawn from public sales by manufacturers because of safety or other issues.
“Device regulation is just so much weaker than drug regulation, and it doesn’t make any sense,” said Dr. Xu. The question is why should high-risk medical devices be held to a lower standard of evidence than drugs? Dr. Xu also expressed concern that the 21st Century Cures Act, legislation that has passed the House and is being considered in the Senate, would make device regulation weaker than it already is.