Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately.
Since FDA reclassified surgical mesh products to class III (high risk) in 2016, the agency said the two manufacturers, Boston Scientific and Coloplast, did not demonstrate a reasonable assurance of safety and effectiveness for these devices. The reclassification came after FDA received thousands
of reports of injuries, including pelvic pain and bleeding, caused by the devices.
A strongly worded FDA safety communication in 2016 also caused the use
of surgical mesh to decline. Some manufacturers voluntarily recalled
and discontinued manufacturing their transvaginal mesh products in recent years too. These include C.R. Bard’s Avaulta Plus transvaginal mesh and the GyneCare product line from Ethicon, a division of Johnson & Johnson, which continues to face lawsuits.
“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. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health.
The companies will have 10 days to submit their plan to withdraw these products from the market.
And although these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required by FDA to continue follow-up of the subjects already enrolled in their postmarket surveillance studies.
In February, FDA also convened an advisory panel
to solicit expert input on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP.
“The panel recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair,” FDA said.
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. FDA said it agreed with panel’s recommendations, “and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve them.”
Boston Scientific told Focus in a statement: "We are deeply disappointed by the FDA’s decision on our premarket approval applications (PMAs) for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives. Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps."
The nonprofit Public Citizen added in a statement: "Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had 'not demonstrated a reasonable assurance of safety."
Article updated with comment from Boston Scientific and Public Citizen.