J&J withdraws controversial vaginal mesh from Australian market
Johnson & Johnson has withdrawn its controversial vaginal mesh product from the Australian market after missing a deadline requiring all such products to carry warnings of potential side-effects. The move follows legal action from more than 700 Australian women who were left in constant pain after having the mesh implanted.
The Therapeutic Goods Administration (TGA) required manufacturers to update the product information of all transvaginal sling and mesh products by 17 January – a deadline which J&J let pass by. The US firm has now withdrawn its supply of its Gynecare TVT device in Australia and New Zealand in order to “consider their options in response to TGA’s request to update the Instructions for Use of their products”.
“The company is assessing the new requirements and the global regulatory implications,” a spokesperson for the company remarked. “Importantly, this is not a product recall and no action is required by patients who have received TVT products. No new orders will be shipped to customers.”
Meanwhile, the New Zealand Medicines and Medical Devices Safety Authority last month ordered vaginal mesh manufacturers to prove the safety of their products or withdraw them from the market.
It is estimated that 100,000 Australian women have been fitted with the device since 2000 as a treatment for pelvic organ prolapse or urinary incontinence. The lawsuit brought against Ethicon, a subsidiary of J&J, by the victims is still ongoing,
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