Pharmaceutical

FDA refuses Public Citizen’s request to ban transvaginal mesh from market

vaginal mesh sling FDA refuses Public Citizens request to ban transvaginal mesh from marketThe U.S. Food and Drug Administration (FDA) has rejected the request made by Public Citizen in 2011 to recall existing surgical mesh products, specifically transvaginal mesh, and ban them from the market. The FDA says that a rigorous review is sufficient enough. The FDA said it “may consider future action against individual products or this product type as appropriate.”

Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used to shore up pelvic organs that have become displaced due to age, childbirth, hysterectomy or obesity. Reported complications from the transvaginal placement of the mesh include erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse and urinary and fecal incontinence. Often women require surgery to remove the mesh. In some cases, this can require multiple procedures without successful removing all of the mesh. Transvaginal mesh has been the subject of thousands of lawsuits.

However, the FDA feels that its recent order to require premarket approval for this product is enough. “As a result of these [surveillance] orders, many manufacturers have elected to cease marketing devices indicated for transvaginal [pelvic organ prolapse] repair,” the FDA wrote.

Michael Carome, director of Public Citizen’s Health Research Group and the petition’s author, said, “Obviously we were pleased that they were taking this step, but we know that this is a long overdue action, and we found it disturbing that it had taken so long.”

The FDA is required by law to find that the product, “presents substantial deception or an unreasonable and substantial risk of illness or injury.”

Carome has accused the FDA of being too timid and he believes that there is plenty of evidence to show that this device should be taken off the market. “I think, as they do all too often, they’re bowing to the interests of [corporations] and not acting in the interests of patients and public health,” Carome said.

The battle over transvaginal mesh is not likely to end here, however. As we reported Monday, another consumer action group, the Corporate Action Network, sent a letter to the FDA dated July 11, demanding the immediate ban of the marketing of non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP), otherwise known as transvaginal mesh (TVM), and asked the agency to order all manufacturers of these products to recall them immediately.

Sources:

Law 360
Righting Injustice