Thursday, June 21, 2012

J&J to Stop Selling Pelvic Mesh Tied to Lawsuits

Johnson & Johnson plans to stop selling surgical mesh implants used to treat women's health problems, which have been linked to injuries and triggered hundreds of lawsuits.

The company sent a letter Monday to judges in New Jersey and West Virginia who are overseeing patient lawsuits against the company. J&J said it plans to phase out four mesh products over the next three to nine months.
The plastic mesh is used to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. About 75,000 women had prolapse surgery with mesh inserted through the vagina last year. A similar procedure using an incision in the abdomen is less common.
J&J said the mesh products are safe and that it is not recalling them.
"Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy," the New Brunswick, N.J., company said in a statement.
But the U.S. Food and Drug Administration reported last year that the implants were associated with higher rates of pain, bleeding and infection than traditional surgery with stitches. The agency said 10% of women experienced erosion or exposure of the mesh within 12 months of having the mesh implanted. More than half of these women required follow-up surgery to remove the mesh. Some required three surgeries.
At the same time, the FDA said it saw no evidence that using mesh led to better outcomes than traditional surgery with stitches.
In January, the FDA ordered J&J and five other companies to conduct rigorous studies to track the complication rates with their products over time. J&J said in its letter it expects the FDA to waive that requirement once it phases out the products.
Consumer safety advocates hailed the announcement as a victory.
"These companies know they will never be able to prove safety and efficacy of these devices in the studies mandated by the FDA in January of this year," said Lana Keeton, a Miami resident who has undergone 17 surgeries to remove mesh that was implanted in 2001. Keeton's group, Truth in Medicine, has lobbied the FDA on the risks of mesh in recent years.