The FDA has ordered the two remaining medical device companies, Boston Scientific and Coloplast, selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the US. The FDA said the two companies did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications. Both companies are expected to appeal the order.
Surgical mesh is implanted in the vaginal wall to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area. Complications have included bleeding, pain, inflammation and dislodging or protrusion through the wall that can cause infection. Many women have required a second surgery to repair the damage. As the number of serious complications increased significantly, the FDA reclassified this type of pelvic mesh as high risk in 2016. Tens of thousands of lawsuits have been filed in recent years claiming transvaginal mesh implants caused various injuries.
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