Major Recall of Australian Breast Implants Over Cancer Fears
Regulators are taking action on all breast implants and breast tissue expanders sold in Australia over cancer fears.
The Therapeutic Goods Administration is imposing strict regulations following reports of about 100 cases of breast-implant associated anaplastic large cell lymphoma in Australia, including four deaths.
Eight types of breast implants will be suspended from sale for six months while safety and performance concerns are addressed.
Un-implanted models will also be pulled from the shelves.
But the TGA says the removal of implants in patients with no symptoms or concerns will not be necessary.
Manufacturers will be forced to report all cases of cancer they become aware of to the TGA within 10 working days.
No breast tissue expanders, which are mainly used for breast reconstruction surgery, have been suspended for sale