Manufacturers Boston Scientific and Coloplast have 10 days to provide exit plan for products.
This article was first published on Tuesday, April 16, 2019 in MedPage Today.
By Charles Bankhead, Senior Editor.
WASHINGTON -- The FDA ordered an end to sales of all remaining surgical mesh products used for transvaginal repair of pelvic organ prolapse.
According to the announcement, the FDA determined that "manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of the safety and effectiveness of these devices."
In 2016, the FDA reclassified the mesh as class III (high risk) devices, requiring manufacturers to obtain approval of premarket approval applications (PMAs), the agency's most stringent level of review. The manufacturers have 10 days to submit a plan to withdraw all remaining products from the market.
"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," Jeffrey Shuren, MD, of the FDA Center for Devices and Radiological Health, said in a statement. "That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."
In use since the 1950s for hernia repair, surgical mesh's clinical applications expanded in repair of POP, initially abdominal procedures in the 1970s and then transvaginal repair in the 1990s, according to the FDA. The agency cleared the first mesh device for transvaginal repair of POP in 2002.
About 10%-15% of women have surgery to repair POP in their lifetimes. The proportion of transvaginal procedures using surgical mesh decreased after the FDA issued warnings about risks associated with transvaginal mesh.
In February, an FDA advisory committee concluded that a favorable recommendation for the mesh devices' benefit-risk profile would require a demonstration of superior effectiveness versus native tissue repair at 36 months and at least comparable safety outcomes.
"The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve them," according to the FDA statement.
Boston Scientific and Coloplast will be required to continue follow-up of patients who underwent transvaginal repair procedures using the mesh products in "522" clinical studies. Women with the mesh in place should continue with annual or routine check-ups and follow-up care, and no action is needed so long as they remain satisfied with the surgery and are not having complications, the FDA advised.
"Patients should notify their healthcare professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex," according to the statement.
In response to the FDA announcement, representatives of Boston Scientific issued the following statement:
"We are deeply disappointed by the FDA's decision on our premarket approval applications 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."
A spokesperson for Coloplast said the company will comply with the FDA decision to halt sales of the products, but noted that the FDA action is not a recall and has no impact on other Coloplast products.
“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.”
Jeffrey Shuren, MD, FDA Center for Devices and Radiological Health
The FDA determined that "manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of the safety and effectiveness of these devices."
Coloplast said it will comply with the FDA decision to halt sales of the products, but noted that the FDA action is not a recall and has no impact on other Coloplast products.
Boston Scientific said it was 'deeply disappointed by the FDA's decision' and that the inaccessibility of the mesh products will limit treatment options for the 50% of women who will suffer from pelvic organ prolapse.