FDA orders manufacturers of surgical pelvic mesh to stop selling all devices
The Food and Drug Administration announced April 16 that manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse (POP) can no longer sell their products legally in the U.S. because they are unsafe.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
Boston Scientific and Coloplast – two manufacturers that sell the mesh – were informed by FDA that neither one has been able to demonstrate “a reasonable assurance of safety and effectiveness” which is the premarket review standard that now applies to the mesh products since the agency reclassified them as class III/high risk three years ago. FDA said the companies were required to submit and obtain approval of premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the U.S.
Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue with most made from synthetic materials or animal tissue. Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, and Coloplast filed a PMA for its device, Restorelle DirectFix Anterior.
The PMAs submitted by the two manufacturers did not satisfy the agency’s advisory panel because they lacked an adequate assessment of the long-term safety of the devices while simultaneously failing to demonstrate an acceptable long-term benefit compared to transvaginal surgical tissue repair alone, also called native tissue repair. FDA said without strong evidence that the benefit of using them outweigh the risks, the products are considered unsafe and ineffective.
This is not the first-time the vaginal mesh products have received a negative reaction from FDA and the women who need POP repair. FDA says the number of procedures women are having has dipped significantly in recent years due to a series of warnings and complications (e.g., mesh erosion) experienced by patients who have had the procedure. The companies now have 10 days to submit their plan to withdraw all products from the market and will be required to continue follow-up on the women who have already enrolled in some 522 studies.
