Australia suspends sales of certain textured breast implants ... | 合法醫療器材資訊網

2019年10月3日—EuroImplantsPtyLtd(EurosiliconeSAS)Model132037,CristalineParagelcohesivegelimplant.JTMedicalPtyLtd(PolytechHealth ...

The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in the country, including four deaths. During the suspension, which begins October 25, health officials will address “a number of safety and performance concerns” with implant makers, the TGA said[1] in a news release.

Any stock of unused devices in the market will also be recalled during the suspension period. No models of breast tissue expanders have been suspended. The suspensions and cancellations affect 13% of the supply of breast implant de...