The medical devices regulator has suspended the sale and use of eight models of breast implants in Australia, while at least one major manufacturer has pulled its devices from the market.
The decision by the Therapeutic Goods Administration (TGA) comes after it initially proposed the ban in July, responding to worldwide fears certain implants are linked to a rare cancer. There have been about 100 cases of the cancer, known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), reported in Australia, including four deaths. "Eight models of breast implants are to be suspended from supply in Australia for six months, while a number of safety and performance concerns are addressed," the TGA said in a statement. "This means that these devices will not be able to be imported, exported or supplied within Australia while the TGA works with industry sponsors to ensure the devices meet all the necessary requirements for patient safety. "Any stock of these un-implanted devices in the market will also be recalled during the suspension period." Read more: https://www.abc.net.au/news/2019-09-27/tga-breast-implant-regulatory-action-australian-market/11552610
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