Jury Awards Woman $2 Million for Avaulta Transvaginal Mesh InjuriesAug 16, 2013
A West Virginia jury has awarded a woman $2 million for injuries she claimed were caused by a defective transvaginal mesh device manufactured by C.R. Bard.
According to a Bloomberg News report, the woman was given $250,000 in compensatory and $1.75 million more in punitive damages following a 12-hour deliberation process in one of the first cases involving a victim of an allegedly defective transvaginal mesh device. The transvaginal mesh device called into question in this case is the Avaulta by C.R. Bard.
C.R. Bard still faces more than 8,000 more similar claims against its Avaulta transvaginal mesh device. Avaulta is no longer available on the market. It was pulled last year after the U.S. Food and Drug Administration (FDA) ordered it and other manufacturers of transvaginal mesh devices to produce post-market safety data that proved their products were safe and effective for the conditions they were approved to treat, according to Bloomberg’s report.
As you’ll recall from our previous reports, transvaginal mesh devices were largely approved through the FDA’s 510(k) “fast-track” approval system that gave clearance to new products when the manufacturers showed they were nearly identical in design to a previously approved medical device. In the case of transvaginal mesh devices, this allowed numerous types of mesh devices to reach women suffering from either stress urinary incontinence or pelvic organ prolapse — the two conditions transvaginal mesh devices are approved to treat.
This is the second time C.R. Bard has lost a case related to Avaulta injuries. Bloomberg recalls that a California woman was awarded $5.5 million last year in the first trial to reach a jury. The woman in this latest case claimed that her Avaulta transvaginal mesh device eroded through the vaginal wall and caused her to suffer severe pain and discomfort, including during sexual intercourse.
Based on our previous reports, erosion of the mesh through the vaginal wall is one common injury linked to a defective transvaginal mesh device. Other injuries linked to these devices include severe pain, infections, excessive bleeding, organ perforation, and urinary complications.