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.
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.
Another J&J lawyer, Christy Jones, told jurors in her opening statement that a 2005 study of the Gynecare Gynemesh, a predecessor to the Prolift, showed an 84 percent success rate.
Jones also denied Gross’s claims yesterday in her opening statement. Ethicon, she said, properly warned Gross and her surgeon of the risks associated with implanting a Prolift device. Gross, she said, needed relief after her rectum fell, and her pelvic floor had been weakened by earlier surgeries.
J&J in August stopped selling four mesh devices in the U.S., including the Prolift. The company said in June that it would end sales worldwide based on the products’ commercial viability, not their safety and effectiveness.
The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).
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