Product News and Recalls

California Jury awards $5.5 million in mesh case

Christine Scott, a woman awarded $5.5 million for injuries from a transvaginal mesh implant, said she hopes the development will help “get the word out to women,” according to a report on KGET out of California.

A California jury ruled this week that C.R. Bard Medical, maker of Avaulta Mesh, is responsible for the damages. It’s the first case involving vaginal mesh implants to go to trial, but over 600 more lawsuits are pending from women who claim the devices injured them.

Transvaginal mesh implants are used to treat urinary incontinence and pelvic organ prolapse, a condition that occurs when weakened muscles can no longer support pelvic organs. Neither condition is debilitating or life-threatening, and safer treatments are available for both.

Scott, an active runner, got the implant to correct a leaky bladder. The device began cutting her colon, and tissue continues to grow through the tiny holes in the mesh. She had already had eight surgeries, and said she doesn’t know if she’ll need more.

KGET reports Scott as saying: “The hardest part, I will tell you, through this whole thing, is having to keep quiet, watching women still get hurt. But, I was legally not able to get out there and tell and… every day I was like ‘please be over so I can talk.’ So, when I got that verdict it was like ‘Thank you God.’ Now we can do something.”

The decision comes soon after Johnson & Johnson’s Ethicon unit announced it would stop selling four lines of vaginal mesh devices, that it had marked for years despite thousands of reports of device failure.

A U.S. Food and Drug Administration report in August 2011 declared that vaginal-mesh products should be classified as posing high risk to patients. And in January, the FDA ordered 31 manufacturers, including Bard and Johnson & Johnson, to study rates of organ damage and complications linked to the mesh implants.

The FDA initially approved transvaginal mesh implants through a legal loophole that allows for the approval of medical devices that haven’t been clinically tested in humans, based on their alleged similarity to products already on the market.

The KGET report quotes Scott’s lawyer as saying: “They tested this on 16 rats, 12 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women.”

You should consult with a doctor if you have any ongoing symptoms or health concerns from a transvaginal mesh implant. If you have significant injuries, you should also consult with a transvaginal mesh lawyer to discuss your legal rights.

See the story here:

http://www.kget.com/news/local/story/Couple-wins-landmark-trial-against-medical-company/1dfRbhUuZ0-C33fcd890gg.cspx