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. Those complications sometimes require multiple surgeries to remove or reposition the mesh.
The new requirements do not apply to mesh products when used to treat other conditions such as hernias or urinary incontinence. 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 FDA advisers said those benefits have not been established.
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.
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 does not apply to mesh inserted through the abdomen, an alternate approach that requires a larger incision.
Companies with products already on the market will have 30 months to submit their applications to the FDA. Companies that want to market new pelvic mesh products will have to submit their applications for FDA review before they can be sold.
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 most 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.