TGA regulatory action on textured breast implants proposed
July 11, 2019
Proposed cancelling or suspension of a number of textured implants in Australia, announced by regulatory agency
11 July 2019
Australia’s Therapeutic Goods Administration’s (TGA) today released proposed regulatory actions to cancel or suspend several textured breast implants following extensive laboratory analysis and statistical review.
Textured breast implants, which have a rough surface, have been associated with a rare form of cancer of the immune system called anaplastic large cell lymphoma (ALCL). ALCL is not breast cancer.
The TGA said, “No decision has been made to suspend or cancel the relevant products at this time.”
Affected companies have until 24th July to respond to the proposed regulatory action before the TGA makes a final decision.
Women with textured implants are not advised to have the implants removed as a precautionary measure.
“Because the risk to women who already have these implants is very low, experts do not recommend that women who already have them need to have them removed unless there is a confirmed diagnosis of ALCL,” wrote the TGA.
BIA-ALCL is considered a rare condition estimated to affect between 1 in 1,000 – to 1 in 10,000 women and is usually cured by removal of the implant.
Anyone with concerns about their breast implants should speak to their GP or surgeon.
The ABDR encourages consumers and health care professionals to visit the TGA’s dedicated Breast Implant Hub to find out more about breast implants and BIA-ALCL, including signs and symptoms.
Details of the TGA’s proposed regulatory actions, the list of affected implants and the response by international regulatory authorities to breast implant associated (BIA) ALCL can be found here.