The quality community received a sobering reminder recently of the importance of their work when...
Recently, the FDA ordered that all sales and distribution of
surgical mesh for transvaginal repairs be stopped. Both companies still selling
the mesh have 10 days to submit plans to remove the mesh from the market. The
ruling is the latest in a series of FDA actions targeting the escalating safety
risks associated with the mesh. The FDA’s order garnered mass attention nationwide
in large part because there are currently an estimated 100,000 women actively
suing for issues related to the mesh; culminating in roughly 48,000 lawsuits
nationwide.
The recent decision was not without precedence. In 2016 the
FDA reclassified the surgical mesh as a class III (high risk) device. Class III
devices are required to obtain Premarket Approval (PMA). In the case of the
surgical mesh, the FDA stipulated that certain and explicit evidence be
submitted as part of the PMA. Specifically, the FDA required data proving that surgeries
that took place with surgical mesh were more successful than those surgeries in
which the surgical mesh was not used. In their recent statement, the FDA noted
that the requested evidence was lacking in the PMAs that were received. Therefore,
the decision was made to remove the class III surgical mesh from the market.
Simply filing a PMA is not enough. As is the case with the surgical mesh, multiple Premarket Approvals were filed, but none of them were approved. If your company is currently filing a PMA or looking to file a PMA, Medpoint can help. Our consultants can help you navigate the process from start to finish. To learn more, contact us today at hello@medpoint.com.
Sources:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM636114.htm
https://www.cbsnews.com/news/boston-scientific-ordered-by-fda-to-stop-selling-gynecological-mesh/
www.nytimes.com/2019/04/16/health/vaginal-pelvic-mesh-fda.html
