The U.S. Food and Drug Administration has ordered Marlborough medical device maker Boston Scientific and another manufacturer to immediately stop selling transvaginal surgical mesh products.
In a Tuesday announcement, the FDA said the companies “have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” which is the agency’s premarket review standard now applying to the products since the agency reclassified them as high risk in 2016.
Premarket approval was needed in order for the devices to stay on the market, the FDA said.
Boston Scientific and Denmark-based Coloplast will have 10 days to submit their plan to withdraw the products from the market.
In a statement, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the agency determined it needed evidence showing the devices worked to repair pelvic organ prolapse better than corrective surgery without the devices.
“That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Shuren said.
The FDA’s ban on these products includes two from Boston Scientific, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System.
In a statement, Boston Scientific said it was deeply disappointed by the agency’s decision.
The company said the inaccessibility of the products will severely limit treatment options for 50% of women in the U.S. suffering from pelvic organ prolapse.
“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.
The products have somewhat been the subject of national scrutiny. According to a “60 Minutes” report from last May, more than 48,000 lawsuits relating to the devices have been filed.