Atlanta, GAA jury hearing the first transvaginal mesh personal injury lawsuit has awarded the plaintiff $2 million in damages. In her lawsuit, Donna Cisson alleges that the mesh, one of the line of Avaulta transvaginal mesh products made by C.R. Bard Inc, which she had surgically implanted, caused her bleeding and pain. The Avaulta transvaginal mesh was implanted to treat pelvic organ prolapse (POP), a condition which can cause urinary incontinence and pain, including during sex. Cisson subsequently underwent two surgeries to have the medical device removed.
With some 20,000 transvaginal mesh lawsuits pending in a multi-district litigation (MDL) in West Virginia, Cisson’s case is a bellwether. The jury found that Bard indeed failed to issue warnings regarding the transvaginal mesh design defect.
Consequently they awarded Cisson $250,000 in compensatory damages and $1,750,000 in punitive damages.
A second bellwether trial against Bard is scheduled to go to court shortly. Bard, which is based in Murray Hill, N.J., also faces the first trial in state court coordinated litigation in Atlantic City, N.J., on September 23, the National Law Journal reports.
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The FDA has received over a thousand reports of Bard Avaulta complications associated with surgical mesh since 2005. In October 2008, the FDA issued an alert about complications associated with transvaginal placement of surgical mesh to treat POP and Stress Urinary Incontinence (SUI). At the time, FDA noted that in the previous three years, it received more than 1,000 reports from nine surgical mesh manufacturers of complications associated with their surgical mesh devices. On July 13, 2011, the FDA issued a public notice regarding the use of transvaginal mesh (TVM) for the treatment of POP and Stress Urinary Incontinence (SUI). Doctors and their patients are now advised to consider alternatives to TVM.
Bard, based in Georgia, manufactures, distributes, and markets numerous medical devices. Brand names of Bard’s transvaginal mesh patches include:
Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System