In what will likely be the first of many trials against manufacturers of transvaginal mesh products across the country, a California woman, Christine Scott, was recently awarded $5.5 million in damages by a jury in her case against C.R. Bard, the manufacturer of the Avaulta Plus Biosynthetic Support System, a vaginal mesh implant, which caused her debilitating injuries, requiring nine separate revision surgeries when the implanted mesh eroded.

Ms. Scott underwent the implant procedure to treat urinary incontinence and pelvic organ prolapse. Ms. Scott’s doctor, who implanted the device in 2008, was found responsible for paying 40% of the judgment. The evidence at trial was that Ms. Scott suffered from incontinence, severe pain and an inability to engage in sexual relations with her husband due to the extrusion of the mesh into her vagina.

The plaintiff presented evidence at trial that the manufacturer did not test the medical device, and was not required to prove the safety of the device to the FDA pursuant to the controversial fast-track 510(k) approval process, before marketing it. As part of their verdict, the jury found that Bard knew or should have known that surgeons “performing pelvic-floor repair would not realize the potential risks” posed by the implanted mesh.

In July, 2011, after nearly 4,000 adverse events associated with transvaginal mesh were reported, the FDA warned of a rise of “serious complications” associated with surgical mesh for transvaginal repair. Bard is facing hundreds more product liability lawsuits filed by women who have been similarly injured by the mesh products. The other major manufacturers, Johnson and Johnson, Ethicon, Boston Scientific and American Medical Systems also face hundreds of suits. In January 2012, the FDA ordered Bard and 30 other manufacturers of the transvaginal mesh products to study rates of organ damage and complications related to the mesh devices.

SUGARMAN attorneys are actively representing clients in the transvaginal mesh litigation. If you would like more information about transvaginal mesh, or would like to discuss your potential claim, please fill out a Contact Form, call Marianne C. LeBlanc or David McCormack at 617-542-1000 or e-mail Marianne C. LeBlanc or David McCormack.