Johnson & Johnson will stop selling transvaginal mesh devices that are at the center of numerous lawsuits filed by women who say they were injured by the implants. Transvaginal mesh is a type of surgical mesh used to treat pelvic floor disorders including pelvic organ prolapse and sudden urinary incontinence.
The consumer health products giant insisted the phase-out is not due to the mounting lawsuits, and that it is not issuing a recall. “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 company said in a statement.
Despite the statement, the safety of transvaginal mesh, which is made by numerous manufacturers, has been the center of much debate. Last year, the Food and Drug Administration (FDA) heard testimony from women and consumer groups urging the agency to pull the devices from the market because they were causing more harm than good.
Transvaginal mesh is inserted through the vagina to shore up organs that have prolapsed, or dropped, causing symptoms such as urinary incontinence, pain during sexual intercourse, and general discomfort. But in many cases, the mesh may move or erode into the vaginal wall or other organs, which can result in excruciating pain, incontinence and disability. Many women have had to undergo multiple surgeries to have the mesh removed.
Following its review, the FDA fell short of recalling the devices, opting instead to issue a warning that use of the implants could result in serious injuries. The agency also ordered Johnson & Johnson and five other companies to conduct studies on their transvaginal mesh products to better determine safety and efficacy.
Source: Washington Post