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Johnson & Johnson withdraws pelvic mesh device from Australian market
Regulator says the mid-urethral vaginal sling, subject of a class action, is no longer being imported
Mon 22 Jan 2018 23.14 EST
Pharmaceutical giant Johnson & Johnson has withdrawn from the Australian market its supply of the vaginal mesh device that is the subject of a class action before the federal court.
On Tuesday a spokeswoman for Australia’s medical devices regulator, the Therapeutic Goods Administration, confirmed to Guardian Australia that the mid-urethral vaginal sling devices, used to treat stress urinary incontinence in women, were no longer being imported.
The devices are produced by the Johnson & Johnson company Ethicon and no longer appear on the Australian Therapeutic Goods Register, which is a list of products that can be lawfully supplied in Australia.
The TGA asked all manufacturers of transvaginal sling and mesh devices to update the “instructions for use” on the transvaginal mesh and tape products before 17 January to include information about possible adverse events such as severe chronic pain, groin pain, and bladder perforation.
According to the TGA, Johnson & Johnson did not meet this deadline and withdrew the supply of their mid-urethral sling devices to enable them to consider their options.
Robson said he did not have “exact figures”, but the Johnson & Johnson devices were probably the most widely used by surgeons to treat incontinence.
The Johnson & Johnson/Ethicon implant became the subject of a class action run by Shine Lawyers in 2017, with 700 Australian women alleging that faulty pelvic mesh implants caused them debilitating pain.
Similar class actions involving thousands of women are also underway in the UK and US. More than 100,000 transvaginal mesh lawsuits have been filed in the US, the largest number against Johnson & Johnson, the manufacturer of the most commonly used meshes. Shine Lawyers alleges Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients.