Textured breast implants recalled from sale in Australia due to ... | 合法醫療器材資訊網

2019年9月27日—EightimplanttypessuspendedforsixmonthsbutTGAsaysnoneedfor...9-cellCoGelgel-filledNagormammaryimplantrange–textured.

The Therapeutic Goods Administration (TGA) has launched a crackdown on textured breast implants following about 100 cases of a rare cancer, including four deaths, in Australia linked to the devices.

In a statement[1], the agency said it would suspend eight types of breast implants – covering 13% of the Australian market – from sale for six months while safety and performance concerns are addressed. Un-implanted models will be pulled from the shelves.

It comes as medical regulators grapple with concerns about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has resulted in 23 deaths and more than 700 confirmed cases around the world.

Under the new rules, manufacturers will be required to report all cases of the cancer linked to their products within 10 working days.