For the thousands of women who have already undergone transvaginal mesh (TVM) surgery to repair organ prolapses or urinary incontinence, the idea of enduring yet another surgery is stressful and frightening at best. But because mesh is known to have a high failure rate, countless women are forced to endure revision surgery, also called excision.
Introduced as a quick and painless way to repair pelvic organ prolapses (POPs) or stress urinary incontinence (SUI), TVM has instead caused thousands of women pain and suffering. Once it’s implanted through the vagina to hold up sagging organs, the synthetic mesh device is known to erode into nearby tissue. The tiny plastic pieces become sharp and jagged, slicing nearby organs and tissue. The result is infection, fistulas, nerve damage and massive hemorrhaging. Most women who experience mesh erosion choose to undergo revision surgery with the hopes it will fix the problem. What they find is that the eroded mesh has fused with tissue, making it impossible to easily remove. Even the most skilled surgeons have likened the procedure to picking gum out of hair.
Federal Regulators Move Slowly
In 2011, the U.S. Food and Drug Administration (FDA) found that TVM procedures have been dangerous for many women. According to the FDA, more than half of the women who experienced erosion from synthetic mesh required up to three revision surgeries. Still, federal regulators have been slow to make any changes to the availability of TVM. Instead, the FDA asked all the major TVM manufacturers, including C.R. Bard, American Medical Systems and Johnson & Johnson’s Ethicon, to conduct reviews of problems and report back. So far, there is no evidence any of these companies have conducted studies.
At the same time, physicians nationwide continue to promote TVM as a safe alternative to traditional prolapse and incontinence surgery. In 2010, nearly 300,000 TVM surgeries were performed in the United State alone. This is leading to a spike in revision surgeries nationwide.
Transvaginal Mesh Legal Options
So far, six multidistrict litigations (MDLs) have been established to accommodate the scores of patients who have sued. The companies involved are C.R. Bard, Johnson & Johnson’s Ethicon division, American Medical Systems, Boston Scientific, Mentor Corp and Coloplast.
Through the MDL, patients are able to have their cases heard individually while attorney work together to collect evidence and conduct pretrial proceedings. This means that patient’s will receive financial settlements based on the extent of injuries.
In August 2012, the first transvaginal mesh trial held in the United States resulted in a jury award of $5.5 million. The California jury found that C.R. Bard’s Avaulta mesh sliced through the 53-year-old patient’s colon in 2008, forcing her to undergo eight corrective surgeries. During the trial, Bard announced it decided to stop selling its Avaulta system.
If you or a loved one is considering filing a legal action as a result of TVM injuries, it is important to find a group of caring and knowledgeable legal experts. Our patient care advocates can not only help you find an attorney who will handle your case with care and discretion, but will also provide strong emotional support through this difficult time. Remember that you are not alone in your fight for justice.