Boston Scientific and Coloplast—the two remaining U.S. manufacturers of transvaginal surgical mesh—have been ordered by the FDA to halt the sale and distribution of those products across the country, effective immediately.
The agency said it determined the companies did not prove that their mesh products were safe and effective for the repair of pelvic organ prolapse, following their reclassification as higher-risk, Class III devices in 2016.
This meant manufacturers were required to submit new premarket approval applications—including evidence that the use of mesh products worked better than repair procedures using native tissues after three years.
“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, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care,” Shuren added.
Though not a recall, the two companies now have 10 days to provide the FDA with their plans for withdrawing the products from the market. Boston Scientific had filed two PMAs for its Uphold LITE Vaginal Support System and its Xenform Soft Tissue Repair System, while Coloplast had filed for its Restorelle DirectFix Anterior device.
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In a statement to FierceMedTech, Boston Scientific said it is “deeply disappointed by the FDA’s decision,” and that “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 company said. Additionally, Coloplast said that it would comply with the FDA’s findings.
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Both Boston Scientific and Coloplast, as well as other past manufacturers, have been the subjects of multimillion-dollar lawsuits and settlements over the devices—with the Denmark-based Coloplast reportedly paying $16 million to settle lawsuits in 2014, and Boston Scientific finding itself hit with a $100 million verdict. Johnson & Johnson, meanwhile, paid out $120 million to settle thousands of suits in early 2016.
While the products may no longer be used in new patients, both companies are required to continue their postmarket surveillance studies. The FDA said that women who have had transvaginal mesh placements should continue with their routine follow-up care, and that there is no need for additional action if they are not having complications or symptoms such as pelvic or groin pain, or persistent vaginal bleeding or discharge.
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The agency has reported an increase in reported adverse events linked to surgical mesh over the past several years. The FDA issued new recommendations for use in July 2011, and later that year ordered manufacturers to conduct new postmarket studies, after which most companies elected to stop selling the products.
However, the consumer advocacy group Public Citizen deemed the agency’s latest actions long overdue. The organization had petitioned (PDF) the FDA in 2011 to stop the marketing of all non-absorbable surgical mesh products in the indication, and to order a full recall as well. The petition was denied in 2014.
“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,’” Public Citizen said in a statement. “If the agency had granted our 2011 petition promptly, thousands of women would have been spared serious, preventable life-altering harm.”