Consumer groups call transvaginal mesh phase-out a small victory
Several Johnson & Johnson surgical mesh implants that have been tied to a growing number of lawsuits will gradually be pulled from the market, a move consumer watchdog groups applaud. The consumer health products giant says it will phase out four of its transvaginal mesh devices over the next three to nine months “in light of changing market dynamics,” the company said in a statement.
Johnson & Johnson says the phase-out is not a recall and the decision to stop making the mesh is not due to complaints. Consumer groups say fewer transvaginal mesh products on the market is a victory nonetheless.
Transvaginal mesh is used to treat pelvic floor disorders in women, including stress urinary incontinence and pelvic organ prolapse. The mesh is inserted through the vagina to hold up organs that have dropped or prolapsed. Last year, about 75,000 women had the procedure and were implanted with the mesh.
Last year, following a safety review of the products, the Food and Drug Administration (FDA) announced that transvaginal mesh had been associated with a higher rate of pain, bleeding and infections than traditional surgery, and that many women who suffered complications from the mesh had to under go multiple surgeries to have the mesh removed. The agency also advised women to discuss the risks and benefits of the mesh products with their doctors before having surgery.
The FDA also ordered six companies that manufacture transvaginal mesh – including Johnson & Johnson – to conduct safety studies on their devices so that long-term risk could be evaluated. By discontinuing its mesh, Johnson & Johnson says it expects to be exempt from having to track its products.
Consumer watchdog groups are calling the removal of Johnson & Johnson’s transvaginal mesh products a small victory. The groups are lobbying the FDA to ban the products based on injury reports.
Source: Kansas City Star