A study by Northwestern University, published May 4, 2016 in Obstetrics and Gynecology criticized the U.S. Food and Drug Administation (FDA) for approving a number of high-risk health devices based on unsubstantiated clinical studies, including transvaginal mesh.
Dr. Steve Xu, lead researcher 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 suffering from transvaginal mesh complications are concerned about the fast track FDA approval of the device and are seeking answers as why it took the agency so long to classify the mesh as a high-risk medical device.
The FDA claimed the current transvaginal mesh product was similar to older mesh products, according to its website. The device had been cleared under the fast-track process, which indicated the product as safe and effective. It was not until the beginning of 2016 that the FDA classified the transvaginal mesh as a class III, or high-risk medical device. Because the devices risk has been upgraded, they are not subject to more stringent clearance.
Northwestern University researchers examined 18 high-risk devices that were approved between 2000 and 2015. Of those 18, four did not prove to be effective, six were not required to undergo post-marketing safety studies, and three were withdrawn from the market by manufacturers due to safety or other problems.
There are questions as to why some high-risk medical devices have been held to lower clinical testing standards than drugs. Dr. Xu said, “Device regulation is just so much weaker than drug regulation, and it doesn’t make any sense.” Dr. Zu also voiced 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.
For about 15 years, transvaginal mesh products have been used worldwide to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) problems in women. Since then, 27 clinical studies have revealed that one in 12 patients have suffered transvaginal mesh complications.