Johnson & Johnson has withdrawn their supply of mid-urethral vaginal sling devices from the Australian market. Australia’s medical device regulator, the Therapeutic Goods Administration (TGA), has confirmed that these devices are no longer being imported and have been removed from the Australian Therapeutic Goods Register (ARTG).
Effective January 4, 2018, the TGA also removed transvaginal mesh products used only in the treatment of pelvic organ prolapse from the ARTG. These vaginal mesh products, also referred to as single incision mini-slings, differ from mid-urethral slings which are not being universally removed. After analyzing the latest published international studies and results from the TGA’s review into urogynaecological surgical mesh implants, the TGA decided that the risks of using transvaginal mesh devices to treat pelvic organ prolapse outweigh the benefits.
Mesh implants were marketed as a low-cost option to treat stress urinary incontinence and pelvic organ prolapse commonly caused by childbirth complications. The devices are the subject of a class action against Johnson & Johnson alleging that meshes caused chronic and debilitating pain and erosion in hundreds of Australian women. Thousands of patients in the United States, Canada, and the UK have launched similar class actions.
Adequate testing and randomised controlled trials were not conducted before the devices were approved and launched onto the Australian market. Instead Johnson & Johnson focused on aggressive marketing campaigns directed at surgeons, highlighting the devices’ money-making potential. Cases against the manufacturer also allege that the pharmaceutical giant knew it lacked proper testing and the risks were purposefully downplayed.
The Therapeutic Goods Administration required mesh device manufacturers to change the instruction brochure for these products. Instructions for Use (IFUs) must include information about certain adverse effects including groin pain, chronic pain, and bladder perforation. As of January 17, 2017 Boston Scientific and Coloplast have updated IFUs for 13 devices collectively. Johnson & Johnson claims that their decision to discontinue the devices in Australia is based on commercial viability and not safety and efficacy, as the cost of a change in labeling would exceed the value of sales.
Consumers and healthcare providers are urged to report any adverse events or problems involving mesh devices. The Bramzon Law Firm PLLC remains committed to defending the rights of thousands of people affected by mesh. If you have any questions about mesh devices and how we can help, please contact us today.