J and J also has a part in the vaginal mesh mess with their product and lawsuits are starting here too.  The questions here are the fast track approval for the Prolift mesh imagedue to the fact that it is similar to Gynemesh a product made by another company.

The product was put on the market in 2005 and was not given approval by the FDA until 2008.  The FDA asked in 2007 for a 501k submission and again after it has been out there for a couple of years already.  All companies now who make the mesh product were ordered by the FDA to study organ damage and other complications from the mesh.  In 3 years the FDA accumulated over 100 complaints on the Prolift product.  This is yet one more issue for J and J to work with and settle.  BD  

Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.

J&J introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, said Morgan Liscinsky, an FDA spokeswoman, in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.

Andrew Sokol, an associate professor of obstetrics/ gynecology and urology at the Georgetown University School of Medicine, said he was “absolutely concerned” after hearing that J&J marketed the Prolift without FDA approval.

“That information would have been important for most surgeons,” Sokol said. “Most surgeons probably would have not used a completely new product if there was no oversight.

http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html?

0 comments :

Post a Comment

 
Top