The Food and Drug Administration orders Boston Scientific and Coloplast to stop selling surgical mesh used for some pelvic operations.
The Food and Drug Administration on Tuesday ordered Boston Scientific and Coloplast to stop selling surgical mesh used for some pelvic operations.
"Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps," it added. Manufacturers were required to submit applications with the FDA and receive approval in order to keep selling the devices in the U.S. after the agency reclassified them in 2016. The agency wanted evidence showing they worked better than surgery without using the mesh to repair pelvic organ prolapse, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
The mesh was used for transvaginal repair of pelvic organ prolapse, a condition where muscles supporting the pelvic organs become weak or loose, allowing the organs to drop into or out of a woman's vagina. Surgical mesh for decades has been used to fix the condition. However, the FDA in recent years has warned about the risks associated with the devices.
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