“I would bleed, hurt, go home hurting,” Janet Dotson told Click2Houston News. “It was extreme pain.” Dotson, like thousands of women, had surgery to repair a pelvic floor disorder, only to be left in worse shape than before surgery. Dotson wants answers, and now the Food and Drug Administration (FDA) is searching for some.
Pelvic floor disorders include pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both conditions are common. POP occurs when the pelvic organs fall, or prolapse, causing symptoms such as pain and urinary incontinence. It is commonly caused by age, obesity and childbirth. SUI is the unintentional leakage of urine, especially when laughing, coughing or other similar stresses.
One common way to treat both conditions is by surgically inserting mesh into the vagina. Surgical mesh is used to in procedures such as hernia repairs, however, its use in transvaginal procedures has come into question in recent years.
The FDA has noticed a growing trend in complaints with the mesh. Many cases report that the mesh erodes into the vaginal wall, causing pain, incontinence, and disability. Many women have had to be hospitalized and undergo repeat surgeries to remove the mesh. Often, they are left with worse symptoms than before surgery. Several women have sought legal counseling.
The large number of complaints has led the FDA to conduct a safety review of transvaginal mesh, ordering mesh makers to track women for three years who have the mesh implanted for the treatment of POP or SUI. Until then, the products will remain on the market.