“I never had this before, nothing so bad that you could just sit down and cry. You just don’t know what’s going on with your body.” Canadian resident Diane McLaughlin recalls the severe pain she experienced shortly after surgery in 2006 to correct a problem that was causing her urinary incontinence.
The operation involved the transvaginal insertion of surgical mesh to shore up her bladder, which had prolapsed and was causing the embarrassing symptom. But neither her doctor nor the medical device’s literature warned her of the possible risks of the procedure.
Transvaginal surgical mesh, also known as pelvic mesh or bladder sling, is used to treat pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The surgery can help alleviate symptoms for some women, but many have found themselves suffering even more after having the surgery.
The problem occurs when the mesh moves or erodes into the pelvic wall. This can cause a host of problems including pain during intercourse, pain during urination, vaginal and urinary infections and injuries to the bowel, bladder and vagina. Diane suffered severe pain that radiated down her leg.
The Food and Drug Administration (FDA) first warned that there were problems with the mesh in 2008. A second warning was issued in 2010, when reports of problems skyrocketed. Then, in July 2011, the FDA conducted a safety review. Experts fell short of banning the product and instead issued stronger warnings about possible complications.
The warnings come too late for many women, including Diane. She, like many women in her situation, has decided to file a lawsuit against the makers of her transvaginal mesh. The lawsuit aims to establish proper warnings on the magnitude of the risks and failure rate so doctors and patients can make informed decisions about transvaginal mesh.
Attorneys at Beasley Allen Law Firm are currently investigating cases of injuries caused by transvaginal mesh.