'Outrageous': banned breast implant maker flouts TGA and safety concerns

Sydney Morning Herald

25 November 2019 - The Therapeutic Goods Administration is demanding answers from the manufacturer of a banned breast implant after the company celebrated the regulator granting access to the implants despite lingering health concerns.

German company Polytech said in a press release it was “delighted to announce that the Australian TGA (Therapeutic Goods Administration) is allowing continued access to POLYTECH Microthane breast implants”.

But the press release is dated two weeks before the TGA granted access to the implants to six cosmetic surgeons for 36 patients on a case-by-case basis.

Read Sydney Morning Herald article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Regulation , Australia , Device