Johnson & Johnson says it is not recalling its controversial transvaginal mesh devices, but it does plan to discontinue sales of four of the products over the next three to nine months. The consumer health care giant sent a letter about the phase out to judges who are overseeing lawsuits against the company from women who allege they suffered injuries after being implanted with the mesh.
Transvaginal mesh is a type of surgical mesh that is used to repair pelvic floor disorders such as pelvic organ prolapse (POP) and sudden urinary incontinence (SUI). It is sometimes referred to as a bladder sling.
POP and SUI are common conditions that affect women due to age, childbirth or weight gain. The conditions occur when pelvic organs drop, or prolapse, causing discomfort, incontinence and pain during intercourse. The conditions are often treated by the surgical insertion of mesh through the vagina to hold pelvic organs in place. About 75,000 women received the mesh for POP or SUI repair last year alone.
But the Food and Drug Administration (FDA) reported last year that the transvaginal mesh was associated with more complications, including pain, bleeding and infection, than traditional surgery. In about 10 percent of women, the mesh eroded or moved out of place less than a year after surgery. The pain was so excruciating for some women that they were unable to work or resume daily activities. For women who experienced complications, additional surgeries – sometimes two or more – were needed to remove the mesh.
In January, the FDA ordered Johnson & Johnson and five other companies that sell transvaginal mesh to conduct studies on their products so that the agency could evaluate whether the products were in fact a safe and effective treatment for POP and SUI. Hundreds of lawsuits were also filed against the manufacturers from women who claimed injuries from the devices.
In its last quarterly filing with regulators, Johnson & Johnson admitted that the lawsuits against the company were increasing and that it had set aside funds to cover the cost of litigation associated with transvaginal mesh.
Source: Huffington Post