MESH LAWSUIT Mesh implants used to repair pelvic collapse in women will face tighter federal scrutiny.

The FDA is putting new measures in place for transvaginal mesh safety. The agency on Monday reclassified surgical mesh for transvaginal pelvic organ prolapse (POP) repair from a moderate-risk Class II device to a high-risk Class III one, a move that forces the makers of transvaginal mesh to submit a premarket approval (PMA) application for the devices to prove that their products are safe and effective for the transvaginal repair of POP, a procedure that has been linked to numerous mesh-related adverse events, including pelvic pain and organ perforation.

Before yesterday's announcement, vaginal mesh products used in the treatment of POP and stress urinary incontinence were categorized as Class II, or moderate-risk, medical devices by the FDA. This classification put a lighter burden on manufacturers to gain approval for their new products. Such devices are not required to undergo human testing if it can be shown that they are "substantially equivalent" to a product already on the market.

Vaginal mesh products currently on the market to treat POP transvaginally have 30 months to submit a PMA. The 5 leading manufacturers of vaginal mesh are Johnson & Johnson's Ethicon division, C.R. Bard, American Medical Solutions, Boston Scientific and Coloplast. New meshes will be required to have a PMA before the FDA approves them for marketing. Mesh used for the treatment of stress urinary incontinence or abdominal repair of POP will not be subjected to increased FDA oversight.

The reclassification and PMA requirement are the latest in a series of steps the FDA has taken to increase the safety of transvaginal POP repair involving surgical mesh. In 2008 and 2011, the FDA issued warnings to physicians and patients about increased incidences of adverse outcomes. In 2011, the FDA created an advisory panel to assess current safety practices and develop recommended actions regarding the use of vaginal mesh. A year later, the FDA ordered mesh manufacturers to conduct post-market surveillance studies in order to address specific safety concerns about the use of their meshes during POP procedures.

William Maisel, MD, MPH, the deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, says the stronger oversight will help to address the significant risks associated with surgical mesh for repair of POP. He adds, "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."

Just last month, a court ordered Johnson & Johnson to pay $12.5 million to an Indiana woman who claimed the company's vaginal mesh caused extreme pain during sex.

Daniel Cook