"We couldn't assure women that these devices were safe and effective long term." With these words, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, announced a total ban on the remaining surgical mesh products used in the transvaginal repair of pelvic organ prolapse. The FDA's announcement does not affect mesh used for other procedures.
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Making good on the work of thousands of public health advocates, the FDA has ordered Coloplast and Boston Scientific, the two remaining manufacturers of transvaginal mesh, to submit a plan within 10 days to remove their remaining stock from the market. Agency experts say the manufacturers had failed to prove that their mesh products were safe and effective for the repair of pelvic organ relapse, following on the reclassification of these devices as high-risk products in 2016.
Tens of thousands of women have filed product liability lawsuits against manufacturers over similar devices. Coloplast settled a round of such lawsuits in 2014 for $16 million. Boston Scientific was hit by several major jury verdicts, including a $100 million judgment in 2015. Despite the FDA's move to pull the products from the market, more lawsuits could be on the way.
"In order for these mesh devices to stay on the market," Dr. Shuren continued, "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." The FDA announcement came on Tuesday, April 16, 2019.
Despite long-standing safety concerns, thousands of women continue to receive transvaginal mesh products to repair pelvic organ prolapse, a condition in which weakened muscles and ligaments allow the pelvic organs to fall below their normal position, creating a bulge (prolapse) in the vagina. Gynecologists began experimenting with mesh patch solutions for the condition in the 1990s, the FDA reports, with the first product specifically approved for the indication arriving in 2002. About 10% to 15% of all women will undergo a surgery to repair pelvic organ prolapse within their lifetime.
The number of transvaginal mesh repair procedures has fallen in recent years on the heels of multiple safety warnings, but the FDA's recent announcement is sure to stamp the operation out - at least for now. In February, an advisory committee for the agency determined 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," according to Medpage Today. "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," the FDA said in its announcement.
In 2016, the FDA reclassified transvaginal mesh implants as Class III - High Risk - devices, subjecting the products to the agency's most rigorous approval process and forcing manufacturers to resubmit their devices for renewed approval. Most mesh manufacturers withdrew from the market due to the heightened regulatory pressure. That left only Boston Scientific and Coloplast competing for FDA approval of their transvaginal mesh products.
Boston Scientific and Coloplast have been ordered to create plans for removing the products from the market. Their exit plans are due in ten days. Alongside this requirement, the manufacturers will be required to continue follow-up for the women who underwent transvaginal repair procedures as part of clinical studies.
Women who have already received a mesh implant have been told to continue with their routine check-ups; no immediate action is required so long as women remain satisfied with the surgery and do not experience complications. "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 FDA statement.
In the wake of the FDA announcement, representatives for Boston Scientific released the following comments:
"We are deeply disappointed by the FDA's decision on our premarket approval applications for the Uphold LITE Vaginal Support System and the Xenoform 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."
Coloplast has declined to comment on the decision, but emphasized that the FDA's announcement is not a recall. The company had submitted its Restorelle DirectFix Anterior device for premarket approval.
Healthcare advocacy group Public Citizen, which first petitioned the FDA to ban the devices in 2011, welcomed the FDA's announcement, but noted that it came "too late for the thousands of women who have been irreparably harmed by these devices." The group reiterated its stance that the dangers of pelvic mesh have been apparent for years. Pelvic mesh products, the group said, "are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits in comparison to nonmesh products."