Product News and Recalls

Jury awards $5.5 million in mesh case

In the first case concerning transvaginal mesh implants to go to trial, jurors in California ruled that a manufacturer of the devices and a doctor must pay a total of $5.5 million, Bloomberg reports.

The damages will go to a woman who was left incontinent and in chronic pain because of injuries caused by Bard’s Avaulta Plus vaginal implant. Hundreds more lawsuits are pending, alleging that implants made by Bard, Boston Scientific Corp. and other companies caused organ damage. The decision comes soon after Johnson & Johnson’s Ethicon unit announced it would stop selling four lines of vaginal mesh devices.

Thousands of patients have reported problems with the mesh implants, which are used to treat urinary incontinence and pelvic organ prolapse.

Complaints concern the devices’ tendency to shrink and erode, causing infection, organ perforation and debilitating pain. To make the problem worse, doctors report that it’s extremely difficult to remove the devices once they’re implanted.

A U.S. Food and Drug Administration report in August 2011, based on accounts of side effects, declared that vaginal-mesh products should be classified as posing high risk to patients. Women’s groups are demanding that the devices be recalled, Bloomberg reports.

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 companies must conduct three years of safety studies, regulators said.

The California jurors found that Bard officials were negligent in their handling of the devices. The Bloomberg report quotes a lawyer for the plaintiff as saying: “They seemed to focus on evidence we produced showing that Bard didn’t properly test the product before putting it on the market.”

Transvaginal mesh implants were approved under a U.S. Food and Drug Administration loophole that allows for medical devices to be approved without clinical testing in humans, based on their alleged similarity to devices already on the market.

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.bloomberg.com/news/2012-07-24/bard-must-pay-5-5-million-over-vaginal-mesh-implants.html