A jury in a Dallas state court has ordered health care giant Johnson & Johnson (J&J) and its Ethicon subsidiary to pay $1.2 million in compensatory damages to a woman who alleged she was injured by a transvaginal mesh (TVM) implant used to treat stress incontinence. Jurors decided the design of the TVT-O mesh sling, often referred to as a “bladder sling,” was defective or unreasonably dangerous. As a result of the defective design of the sling, they found Linda Batiste suffered pain and serious injury when the mesh eroded through her vaginal wall. Ms. Batiste was represented Tom Cartmell of Wagstaff, Cartmell and Rich Freese of Freese and Goss.

The jury’s decision in this case is significant because it was the first occasion where a jury has had opportunity to render a decision after hearing evidence regarding the defective nature of a bladder sling product. The case highlights the substantial evidence that has been gathered establishing the risks of these products, the limited benefits, and the safer alternatives that are available.

More than a million women have been implanted with bladder slings.  Thousands of these women have experienced life-altering injuries as a result of the defective design of these implants, creating a public health problem of enormous proportions.  The full size and scope of the problem will not be known for years to come.  Many women begin to experience pain and other complications years after implant.  In addition, women are continuing to be implanted with bladder slings and pelvic organ devices composed of synthetic mesh.

Transvaginal mesh side effects include erosion of the mesh into surrounding tissue and organs (including the vagina, bladder, and rectum), chronic pain, hemorrhaging, infections, incontinence, and painful sexual intercourse. Reports of complications led the U.S. Food and Drug Administration (FDA) to issue a safety announcement warning that injuries with transvaginal mesh were not uncommon and could lead to multiple surgeries, hospitalizations and even death. The injuries associated with these products are often quite difficult to treat.  For women like Ms. Batiste who experience erosion into the vaginal wall, removing the mesh can be very difficult or impossible. For those that experience nerve damage or have significant scarring, treatment options are very limited.  As a result, many women who experience chronic pain following a transvaginal mesh implant or revision of a transvaginal product are unable to find relief.

Transvaginal mesh injuries are particularly regrettable when you consider they could have been avoided. Neither device used in the treatment of pelvic organ prolapse or stress urinary incontinence was studied in actual women prior to being placed on the market.  J&J and other manufacturers failed to test the materials used in the products to determine if it was appropriate for a permanent implant. Yet Johnson & Johnson and other manufacturers still marketed these dangerous products. Moreover, after the products were placed on the market and manufacturers were notified of complications and serious adverse events, the manufacturers failed to provide information to physicians about the potential problems.

J&J and Ethicon, which is the women’s health and urology division of the company, face more than 12,000 pending lawsuits regarding the mesh implants.  Most of the cases are consolidated before Judge Joseph Goodwin in West Virginia, while other cases, like Ms. Batiste’s, are being heard in state courts.

In addition to Johnson & Johnson / Ethicon, other transvaginal mesh manufacturers that are facing litigation surrounding the devices include American Medical Systems, C.R. Bard Inc., Boston Scientific, Cook Medical, Inc., and Caldera. Leigh O’Dell and Chad Cook, lawyers in our firm’s Mass Torts Section, lead a team of Beasley Allen lawyers who represent women injured by transvaginal mesh. Our lawyers represent a number of women injured by products manufactured by J&J, as well as the other manufacturers listed above. Leigh can be reached at Leigh.Odell@beasleyallen.com; and Chad at Chad.Cook@beasleyallen.com. You can also call these lawyers at 800-898-2034.

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