The agency determined that the manufacturers of the devices, Boston Scientific and Coloplast, did not demonstrate safety and efficacy of their devices after they were reclassified as high-risk in 2016. In order to continue selling the devices in the U.S., the two device makers had to submit and obtain approval through a different device review pathway.
“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. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
The device makers have 10 days to submit their plan to withdraw the products from the U.S. market.
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