Breast implants are high risk medical devices.
This means that we evaluate these products for safety, quality, and performance.
At the TGA, we work closely with the Australian Breast Device Registry. We work together to monitor the ongoing safety and performance of breast implants.
We regulate the supply of medical devices in Australia's market. We do not regulate health practitioners. We also don't compensate patients for any injuries due to their health care or use of a medical device.
Monitoring breast implants
We established an expert working group in 2016. This group aims to:
- provide advice on breast implants, including the risk of BIA-ALCL, and
- assist with with targeted information for consumers and health professionals.
A consumer working group was then established in 2019. The results of our meetings are on our Breast Implant Expert and Consumer Working Groups web page.
Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)
We have been monitoring BIA-ALCL since 2011.
In 2019, a review of all breast implants was undertaken. You can read the update on our Breast implants and anaplastic large cell lymphoma page. As part of the review, we also tested samples sent by Australian breast implant sponsors. You can read the Biomaterials and Engineering Laboratory Report: Non-active mammary implants.
PIP implants
PIP breast implants are implants pre-filled with silicone-based gel. They were made by Poly Implant Prothèse (PIP) in France.
PIP breast implants were available in Australia between 1998 and April 2010. Due to increased ruptures and unapproved ingredients, they were recalled.
Explore PIP implants content on our website.
Cereform implants
In 2014, we removed Cereform silicone gel-filled breast implants and associated sizers from the ARTG. It was at the request of the sponsor, Medical Vision Australian Plastic & Cosmetic Pty Ltd.
We took this action because the manufacturer didn't fully validate the sterilisation process. Still, this doesn't mean the Cereform implants weren't sterile when manufactured.
Read our Cereform breast implants alerts.
Silimed implants
In 2016, we cancelled all medical devices manufactured by Silimed from the ARTG. We found some Silimed devices contaminated with silica and cotton particles.
Read our Silimed medical devices information.