Boston Scientific will add a new safety warning to its transvaginal mesh devices after a review of data by company officials and medical device regulators in Australia. The new warning involving five Boston Scientific transvaginal slings will state that the medical devices are considered permanent implants and that removal can be complicated or impossible.
Transvaginal mesh products have been used worldwide for about 15 years, mostly to treat pelvic organ prolapse (POP) and stress urinary incontinence problems in women. Since that time, 27 clinical studies have shown that one in 12 patients have suffered TVM complications. It has been estimated that 50 percent of women by the age of 50 years will have some degree of POP and more than 10 percent by the age of 80 will require surgery.
The FDA has issued two warnings concerning the mesh devices-one in 2008 and the second, stronger warning in 2011. In 2011, the FDA stated, “There were an enormous number of serious, unique complications with use of vaginal mesh and that these cases were just the tip of a looming iceberg.”
While the warning was issued by Boston Scientific, the company is not the only one selling the defective medical device. Johnson & Johnson alone sold 787,322 of its Ethicon TVM devices in the United States between 2008 and 2014. About 42,000 were sold in California, resulting in its latest lawsuit: California Attorney General Kamala D. Harris announced that her office is suing J&J for alleged false advertising and deceptive marketing of it transvaginal mesh products.
American Medical Systems (AMS) is facing about 46,000 lawsuits. AMS was the first transvaginal mesh manufacturer to resolve its product liability cases and closed its unit that sells the devices.
Many transvaginal mesh devices have been taken off the market. However, in the hands of a specialized urogynecologist some mesh devices can be beneficial to women with pelvic prolapse or stress urinary incontinence.
One of the problems is that the manufacturers over marketed these products to women who did not need them and encouraged ob/gyn physicians without specialized training to implant them. Further, many of the mesh products were poorly designed and inadequately tested. The final failure of the manufacturers was failing to warn doctors and patients of the severity of the potential side effects.