Australian regulator bans certain transvaginal mesh products

Australia's Therapeutic Goods Administration announced that it will remove transvaginal mesh products that are used only for the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG), along with single incision mini-slings used to treat stress urinary incontinence. The regulator said it has provided cancellation notices and notices to impose conditions for the devices to Boston Scientific, Johnson & Johnson, and Coloplast, that will take effect on January 4, 2018.

The TGA noted that following a "review of the latest published international studies and an examination of the clinical evidence," it believes "that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients." Additionally, the regulator said that single incision mini-slings will be removed from the ARTG due to a "lack of adequate scientific evidence" to suggest that the risks to patients associated with their use for the treatment of stress urinary incontinence are outweighed by their benefits.

In July, a class action lawsuit involving more than 700 women in Australia was filed against Johnson & Johnson over complications allegedly caused by the company's vaginal mesh implants. The complications included mesh or tape eroding through, and into, surrounding tissue and organs, as well as incontinence, infection and chronic pain.

Earlier this week, reports suggested that the UK's National Institute for Health and Care Excellence will recommend that vaginal mesh operations are banned from treating organ prolapse in England. The draft guidance, which will be published after consultation in December, will note that the implants should only be used for research.

Did you like this article?