Johnson & Johnson’s Ethicon unit recently asked the U.S. Food and Drug Administration for permission to stop selling four transvaginal mesh implants that caused internal injuries and prompted over 600 lawsuits. The company is not, however, recalling mesh previously sold or implanted, according to a spokesman.
Ethicon first introduced Gynecare Prolift, a form of surgical mesh, in 2005 and allegedly sold the device for three years without proper FDA clearance. The company justified its action by stating the product was similar to another mesh already on the market. The FDA only learned of Gynecare Prolift when Johnson & Johnson asked for permission to market a related product.
Last year, the FDA required surgical mesh manufacturers to reclassify the medical device as a high-risk product requiring human testing after discovering a fivefold increase in reported deaths, injuries, and other complications.
The surgically implanted transvaginal mesh was designed to treat stress urinary incontinence and pelvic organ prolapse, two conditions in which weakened pelvic walls may cause discomfort and lower a woman’s quality of life. Women who had the device implanted complained of mesh erosion, shrinkage, infection, pelvic pain and pelvic floor damage, and blood loss, often requiring surgery to find and remove the mesh.
The FDA has not yet responded to Johnson & Johnson’s request, but the company plans to halt sales on a region-by-region basis with completion expected by the first quarter of 2013.