Medical supply company Johnson & Johnson plans to stop selling transvaginal mesh products, which have been linked to injuries. Similar products have triggered hundreds of lawsuits.
Johnson and Johnson sent a letter Monday to judges overseeing patient lawsuits against the company. Johnson and Johnson says in the letter that it plans to phase out four mesh products over the next three to nine months.
The surgical mesh is used to strengthen the pelvic wall in cases of pelvic organ prolapse. This is when the bladder and/or other reproductive organs fall down into the vagina. Tens of thousands of women had prolapse surgery with mesh inserted through the vagina in 2011.
Johnson and Johnson said the mesh products are safe and that it is not recalling them.
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. According to the FDA, 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.
Transvaginal mesh products were first seen as an improvement over traditional surgery, which can also 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 normally requires for first-of-a-kind devices.
Other manufacturers of pelvic mesh include the following: Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems.
If you or anyone you know has been injured due to transvaginal mesh products, call Harmon Smith & Vourvoulias today at 504-717-2093 for a free case evaluation. Our experienced medical malpractice attorneys are available to provide you with the helo you need to protect your rights.
