Product News and Recalls

J&J official: Company knew mesh devices were dangerous

During a trial over vaginal mesh implants, a Johnson & Johnson official testified that the company was well aware the medical devices were dangerous before putting them on the market in 2005.

In the first of 1,800 such lawsuits to go to trial, a 47-year-old South Dakota woman named Linda Gross is suing over allegations that the health care giant failed to adequately test the devices or warn patients of their risks. Gross alleges that she needed 18 operations and had to quit her nurse’s job because of chronic pain from the mesh implant, Bloomberg reports.

Vaginal mesh implants are supposed to treat pelvic organ prolapse and urinary incontinence by shoring up weakened muscles. But other treatments are available, and the devices have generated widespread complaints about problems including chronic pain, infection and organ perforation.

The trial in New Jersey included testimony by Scott Ciarrocca, a project leader for the development of the device for Johnson & Johnson’s Ethicon unit. Ciarrocca testified that a prototype of the company’s mesh implant failed in 20 percent of women within six months even before the device was first sold in 2005.

The company also found that 27 percent of the devices failed within a year, he testified.

In August, the company stopped selling four mesh devices in the U.S., including the Gynecare Prolift – the type implanted in Gross. Although Johnson & Johnson has announced that it will end sales of the devices worldwide, the company claims that decision is based on the products’ commercial viability and not their safety or effectiveness.

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

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