Surgical Mesh Lawsuit
Written by Faith Anderson on July 25, 2012
Potential Side Effects of Bard Avaulta Mesh
Christine Scott underwent surgery in 2008, receiving C.R. Bard’s Avaulta Pelvic Mesh to repair a leaky bladder. The product liability lawsuit alleges that the vaginal mesh device was defectively designed and marketed without adequate warnings regarding the risk of severe, painful complications following surgery. On Monday, a jury in the California Supreme Court for Kern County awarded the plaintiff $5 million in damages, and also awarded her husband $500,000 for his loss of consortium claim, due to the adverse effects the allegedly faulty mesh has had on the couple’s love life.
Bard Avaulta mesh is a type of transvaginal mesh that is commonly used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. However, surgical mesh has been linked to reports of serious complications occurring after surgery, where the mesh may cause infections, erode through the vagina, or cause pain and other debilitating injuries. Similar complications have been reported in connection with other vaginal mesh and bladder sling devices, including mesh sold by companies like Boston Scientific, American Medical Systems (AMS) and Ethicon/Gynecare.
Surgical Mesh Fast-Tracked by FDA
Many of these surgical mesh products were introduced and marketed to the public without undergoing any rigorous studies to establish their safety and effectiveness. They were approved under the FDA’s 510(k) fast-track approval process, which allows manufacturers to skip the typical pre-market approval process if their product is similar to a device already on the market. In July 2011, the FDA issued a warning about vaginal mesh complications, noting that the agency received at least 2,874 reports of problems linked to the products between January 2008 and December 2010. After reviewing available data on the devices, the FDA concluded that there was no evidence that these vaginal mesh products provide any additional benefits when compared to more traditional POP surgeries.
Bard Avaulta Mesh Removed from U.S. Market
In January 2012, the FDA sent a letter to surgical mesh manufacturers, including C. R. Bard, requiring that they conduct postmarketing studies and trials on vaginal mesh products to determine whether they pose an unreasonable risk of injury for women who receive the mesh transvaginally. Last month, Ethicon, a subsidiary of Johnson & Johnson, announced that it was removing its Gynecare vaginal mesh product from the market, asking the FDA to put a hold on any requirements that the company complete the FDA-ordered studies. Following the verdict in the Scott case, C.R. Bard attorneys announced that the company stopped selling the Avault mesh in the U.S. earlier this month, although the potentially dangerous device is still available in other countries.