The Therapeutic Goods Administration’s proposed regulatory action — which could include cancelling, suspending or recalling implants — follows an extensive review of an apparent association between anaplastic large cell lymphoma and some implants.
Health Minister Greg Hunt said the Government supported the TGA’s proposed action.
France and Canada acted in April to remove certain textured implants from their markets.
As of April, the TGA had received 76 reports of anaplastic large cell lymphoma associated with breast implants in Australian women.
The estimated risk of breast implant associated lymphoma is between one-in-1000 and one-in-10,000.
Experts do not recommend removal of breast implants where there are no problems with the implant.
Breast implant associated lymphoma is usually cured if detected early. The TGA has published information on the proposed action, including information on the specific textured implants, on its website.
Allergan Australia said it was reviewing the TGA action in relation to its Natrelle Biocell textured breast implants and tissue expanders. “Allergan continues to stand behind the benefit/risk profile of its breast implants” including its Biocell products, the company said in a statement on Thursday.
The company said there was no recommendation from any health authority, including the TGA, for asymptomatic patients to have their textured breast implants removed or replaced as a preventive measure.