Following a News 8 medical investigation, Johnson & Johnson will stop selling a surgical mesh product used to help treat thousands of women.
The mesh is a synthetic material routinely implanted transvaginally for pelvic prolapse and bladder control. But last November, we told you about complaints of pain, infection and serious scarring by product users.
The FDA has ordered a safety review and hundreds of lawsuits have been filed.
Johnson & Johnson 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 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 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 percent 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 two or 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.
Mesh products initially were seen as a high-tech improvement over traditional surgery, which also can have complications. Since similar mesh was already used in other types of surgery, the products received fast-track approval from the FDA without the tests that the agency requires for first-of-a-kind devices.
In its last quarterly filing with regulators, J&J said the "number of pending product liability lawsuits continues to increase," and that it has set aside money to pay for litigation costs associated with the mesh, though it didn't specify an amount.
Federal cases against the company have been consolidated in the Southern District of West Virginia. The state cases in New Jersey have been centralized in a state court in Atlantic County. Other manufacturers of pelvic mesh include Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems.