The U.S. Food and Drug Administration (FDA) has raised the risk profile of transvaginal mesh implants used to treat pelvic organ prolapse in women from “moderate” to “high risk.” The move requires mesh manufacturers to submit pre-market approval applications to the FDA in order to better understand the risks associated with the devices.
The risk category change is welcomed by thousands of women who have suffered serious transvaginal mesh side effects. Doctors and patients hope the clinical restrictions will reduce cases of mesh complications, which have included severe pain, internal bleeding, infection, urinary problems and pain during intercourse.
Thousands of women have filed transvaginal mesh lawsuits alleging that the manufacturers released defective devices that caused serious injuries. Recently, Johnson & Johnson subsidiary and manufacturer Ethicon was ordered to pay $12.5 million in a mesh lawsuit filed by a woman who says she was injured after receiving the device.