Transvaginal Mesh POP v SUI Warning

Dallas, TX Margot has undergone three surgeries in an attempt to remove AMS transvaginal mesh she had implanted for stress urinary incontinence (SUI). She is outraged that the FDA reclassified transvaginal mesh as high risk only to repair pelvic organ prolapse (POP). And she is worried that her transvaginal mesh lawsuit may be delayed or reduced because of this action.

In 2008 the FDA’s mesh warning said complications were “rare”. The agency in 2011 upgraded its warning after receiving 2,874 adverse event reports - 1,503 were associated with POP repairs, and 1,371 were associated with SUI repairs. As of January 2016 transvaginal mesh to repair POP was reclassified from class II (moderate-risk) to class III (high-risk). The FDA has given manufacturers of surgical mesh, including American Medical Systems, 30 months to demonstrate their products are safe and effective for POP by way of a Premarket Approval application.

Darlene (not her real name pending her AMS settlement) had an AMS mesh sling implanted for SUI after the 2011 warning. She is on a waiting list for transvaginal mesh removal. “I am only 49 years old but I’m like a 90-year-old incontinent woman,” she says. “Sex has become incredibly painful and I don’t even know if I will ever enjoy relations with my partner after I get the mesh removed. I have learned online from other women that mesh erosion damage is irreparable. I consider myself lucky, however, that I am not in as poor shape as others.” By others, Darlene is referring to women who were told their SUI problems would be a thing of the past with a transvaginal sling implant but they would rather live with incontinence than the mesh.

Three years ago Linda had an AMS sling implanted for urinary incontinence. “Right away I had bladder problems along with spasms and severe pain,” she said. And her SUI has worsened. Mary also had an AMS mesh product implanted, with a similar outcome. Within weeks, Mary was looking for a surgeon to remove it. “My doctor has done whatever he can to avoid this issue, to the point that he has told me it is ‘all in my head,’ and ‘there is nothing wrong’ and ‘I should give it some time,’ ” Mary said. “He is so wrong… What a mess this mesh turned out to be.”

Despite more than 87,000 transvaginal mesh lawsuits filed in the US - making it the largest mass tort action in history - transvaginal mesh to treat SUI is still being advertised in medical centers nationwide. For instance, according to Dr. Jonathan Zaidan, MD, founder and practitioner at Women's Excellence in Bladder Control, "The urethral sling procedure has exceptional, immediate results compared with pelvic floor strengthening. We always like to trial pelvic floor physical therapy first, but if results aren't satisfactory, the TOT sling is the gold standard in treating SUI".

Results have been far from satisfactory for Margot, Darlene, Mary and countless other transvaginal mesh victims. It is unclear why the FDA has added warnings to treat POP and not SUI. Transvaginal mesh slings for SUI and POP are made with the same polypropylene material and they are implanted in the pelvic areas. (LawyersandSettlements hopes to have answers soon.)