
Well it looks like our regulator the Therapeutic Goods Administrator (TGA) is at it again.
It seems that the TGA are granting special access to suspended breast implants, “four weeks after the regulator suspended the implants for six months over links to a rare cancer known as breast-implant associated anaplastic large cell lymphoma.”
However the TGA will not “disclose the specifics of these safety concerns.” Under these circumstances how can any patient give informed consent
The German company Polytech of the Breast Implants in question, celebrated the special access in a press release saying was “delighted to announce that the Australian TGA (Therapeutic Goods Administration) is allowing continued access to POLYTECH Microthane breast implants”.
However their press release was ‘dated two weeks before the TGA granted access to the implants to six cosmetic surgeons for 36 patients on a case-by-case basis.’
The manufacturer also sent a press release to surgeons “touting the successful special access applications as a win for women needing reconstructions”
What is deeply disturbing is that none of the special access applications were for reconstruction patients. They were all for cosmetic breast augmentation.
Professor Anand Deva, Plastic and Reconstructive surgeon, and member of the TGA’s BIA-ALCL expert working group, said the decision to grant access to the banned implants was “outrageous”.