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California Couple Awarded 5.5 Million Dollar Transvaginal Mesh Verdict / Bard Avaulta Mesh Recalled

On July 23 2012, a California couple was awarded $5.5 million through a landmark verdict against transvaginal mesh manufacturer C.R. Bard Medical. Before having a transvaginal mesh surgery for stress urinary incontinence, plaintiff Christine Cooper enjoyed a very physically active life. Mrs. Cooper alleged that she was an active runner and only had the surgery to repair occasional leakage during day to day activities prior to her implant. Mrs. Scott had a C.R. Bard Avaulta Plus Biosynthetic Support System implanted in 2008. Shortly after her surgery, she reported chronic pelvic pain, severe urinary problems, and pain during intercourse, which essentially ended her intimate life with her husband, and the need for over eight corrective surgeries due to mesh erosion and colon perforation. After four years of litigation and court-ordered silence, Cooper was awarded $5 million for her complications and her husband was awarded $500,000, the problems caused for the couple’s love life.

During the trial, Mrs. Cooper often lamented the debilitating nature of her injuries and constantly living in fear potential corrective surgeries for mesh extrusion or erosion. Scott states, “I don’t’ know if I’ll have ten surgeries now. I don’t know if I’ll have one. I don’t know if I’ll have 100. The doctors cannot tell me.” Plaintiffs alleged that C.R. Bard Medical did not perform adequate testing on their Transvaginal mesh products and knowingly sold unsafe products.

Much like similar Transvaginal mesh and bladder sling mesh products sold by told manufacturers such as American Medical Systems, Boston Scientific, and Ethicon/Gynecare, Bard Avaulta mesh was touted as a corrective measure for women suffering from pelvic organ prolapse and stress urinary incontinence. Most products are marketed through the controversial 510(k) approval process, which allows manufacturers to forego premarket testing if they can establish that their product is similar to a product already on the market. In the case of Bard Avaulta mesh, C.R. Bard researches claimed that they only tested their mesh on rats, rabbits, and sheep before moving to place mesh product directly into women.

As a result of the trial, C.R. Bard has stopped selling its Avaulta mesh. The FDA has ordered that more clinical trials and testing be done before the product can be marketed again. Similarly, Ethicon/Gynecare, a subsidiary of Johnson & Johnson, was also ordered to perform additional testing and to recall its popular Gynecare Prolfit, Prosima, and TVT Secur systems from the market.

Christine Cooper’s story is not unlike that of hundreds, if not thousands, of transvaginal mesh client all over the United States suffering from similar complications such as mesh erosion, organ perforation, mesh removal and corrective surgeries, and recurrent infections. If you have experienced any of the complications above and have a transvaginal mesh implant, you may be eligible for financial compensation for lost wages, medical bills and other expenses. Please contact the attorneys at Levin Simes, LLP today at 1 (888) 426-4156 or by filling out the form on this page for a free case evaluation.