The Food and Drug Administration on Tuesday ordered Boston Scientific and another maker of transvaginal surgical mesh implants to stop selling and distributing the product in the U.S. The move is the latest in a series by the agency in response to safety concerns regarding the devices implanted in more than 2 million women.
Commonly used to repair weak or damaged tissue and provide support in the event of pelvic organ prolapse, or POP, the FDA said it is acting to protect the health of thousands of women who undergo transvaginal surgery each year. Neither Boston Scientific nor Coloplast, a Danish manufacturer, have demonstrated the safety or efficacy of the devices, according to the agency.
“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, a physician and director of the FDA’s Center for Devices and Radiological Health, said in a statement.
Boston Scientific said in a statement to CBS MoneyWatch that it is “deeply disappointed by the FDA’s decision.” The medical device maker said the FDA order would limit treatment options for “the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives.” The company added that it would work with the agency as it determines next steps.
Coloplast said the FDA order involved just one of its products. It declined further comment.
The FDA in 2016 reclassified the mesh as high risk, requiring Boston Scientific and Coloplast to get approval under the agency’s most stringent review process to continue selling the devices. The controversial devices, which are made of synthetic or biological material, have sparked tens of thousands of lawsuits by women claiming the.
About one in eight women has surgery to repair their pelvic organ prolapse during their lifetime, with a portion of those surgeries completed transvaginally using surgical mesh, according to the FDA. The percentage of transvaginal POP mesh procedures has declined in recent years amid warnings about the associated risks.