Mesh implants used to repair pelvic collapse in women will face new federal scrutiny, under rules responding to thousands of injuries reported with the problem-prone devices.
The Food and Drug Administration said Monday that makers of pelvic mesh must submit new applications demonstrating the safety and effectiveness of their products. The change follows years of reports of pain, bleeding and infection among women receiving the implants. The new requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.
Plastic mesh is often used to strengthen the pelvic wall in cases of so-called pelvic organ prolapse, in which the bladder or other reproductive organs slip out of place, causing pain, constipation and urinary issues. The mesh is often inserted through the vagina, using a small surgical incision.
The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were introduced for pelvic repair in the 1990s and promoted as a way to speed patients' recovery time. But the FDA said in 2011 that about ten percent of women experienced complications from mesh, sometimes requiring multiple surgeries to reposition or remove it.
Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.
In a second rule, the FDA said vaginal mesh will now be classified as a "high-risk" medical device, subject to additional regulatory requirements. Previously the implants were considered "moderate-risk" devices. The FDA first proposed the changes announced Monday in 2014 draft orders.
Like 90% of medical devices sold in the U.S., pelvic mesh was originally cleared under a streamlined FDA review process for devices deemed similar to older products.