On November 28, the Australian Therapeutic Goods Administration (TGA) decided to ban the use of surgical mesh implants for the treatment of women with Pelvic Organ Prolapse (POP), including products known as “mini-slings” that treat urinary incontinence.
The TGA noted that 45 transvaginal mesh products have been removed from the market in Australia. The only remaining manufacturers of transvaginal mesh were Boston Scientific and Coloplast, and those products will be banned by January 4, 2018.
In the United States, Boston Scientific and 7 other manufacturers were hit with over 100,000 lawsuits from women who were injured by transvaginal mesh side effects over the last few years.
Those side effects commonly include erosion of the mesh through the vaginal wall, infections, organ perforation, chronic pain, inability to have sexual intercourse, vaginal disfigurement, and incontinence.
Most manufacturers in the U.S. have paid settlements to resolve the litigation, but more than 30,000 lawsuits remain pending against Johnson & Johnson’s Ethicon subsidiary. Ethicon pulled its products off the market in the U.S. shortly after the FDA ordered manufacturers to conduct more rigorous safety tests on transvaginal mesh products.
The safety data on transvaginal mesh is still minimal, according to Australian health officials.
The number of lawsuits grew rapidly after July 2011, when the FDA warned that over 5,000 women had reported severe side effects from transvaginal mesh between January 2008 and December 2010.