At the time, the FDA said it might reclassify the devices in a higher-risk category that would require manufacturers to conduct clinical trials in people before receiving approval for sale, rather than clearing them under 510(k).
The FDA said it received more than 1,500 reports of complications related to the mesh from 2008 to 2010, including cases where it eroded into the vagina or caused bleeding and infection. The rate of problems was five times the rate reported from 2005 to 2007.
Jeffrey Grand, a lawyer at Bernstein Liebhard in New York who represents some women suing the mesh makers, said J&J’s decision could be an attempt to prevent more lawsuits against its devices and suggests they might be unsafe.
“I think the timing of everything is going to make it very hard for them to convince the jury that they don’t believe safety isn’t tied to their decision (to discontinue),” he said.
“(And) from our perspective, this is a fantastic development ... We’re happy (the surgical mesh devices) won’t be on the market and hurting more women.”
By Anna Yukhananov and Ransdell Pierson