Johnson & Johnson's Mesh Failure Rate Exceeded 20 Pct, Jury Told

Published: Jan 14, 2013

A prototype of a Johnson & Johnson (JNJ) vaginal mesh implant failed in 20 percent of women within six months even before the device was first sold in 2005, a company official testified today in Atlantic City, New Jersey. The company also found that 27 percent of the devices failed within a year, said Scott Ciarrocca, a project leader for the development of the device for J&J’s Ethicon unit. French researchers had reviewed 87 women who received the type of implant that Ethicon developed into its Gynecare Prolift. Ciarrocca was the first witness at the state court trial of a lawsuit by Linda Gross, 47, who claims J&J sold a defective vaginal mesh implant after testing it inadequately and failing to warn of all the risks. The case by Gross, a nurse from South Dakota, is the first of 1,800 such lawsuits to go to trial. Gross’s attorney, Adam Slater, asked Ciarrocca about the failure, or recurrence, rate while trying to show that Ethicon never adequately studied the risks of the device, which helps shore up pelvic muscles. “The studies seem to indicate that after six months, they had a recurrence rate of more than 20 percent,” Ciarrocca told jurors today. 18 Operations: Gross claims that she had 18 operations to repair damage caused by the Gynecare Prolift implanted in her on July 13, 2006. She accuses J&J, the world’s biggest seller of health-care products, of failure to warn of the risks, defective design, deceit and negligence. On questioning today by William M. Gage, an attorney for New Brunswick, New Jersey-based J&J, Ciarrocca cited other studies that showed more favorable rates of success.

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