Current status of breast implant products in Australia

In October 2019, the TGA took steps to improve the safety of breast implant products in Australia. The list below outlines the current status of breast implant devices and will be updated as needed.

*Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders

What does it mean to say a product has been suspended?

When the TGA suspends a product, it means it is temporarily not allowed to be included on the Australian Register of Therapeutic Goods (ARTG). It will not be available for supply until the sponsor has made the requested adjustments to the product, or improved the information available about their product. If these requirements are met, a suspended product may be re-added to the ARTG at the discretion of the TGA.

In the case of breast implant products, the sponsors/manufacturers of the suspended products have six months to make the required adjustments. If they do not do this, the products will be cancelled, un-implanted stock will be recalled and new patients will not be able to receive those products.

What does it mean to say new conditions have been imposed on some products?

All breast implant devices will now have the following tighter conditions imposed on them in order to be included on the ARTG:

• all cases of BIA-ALCL must be reported to the TGA within 10 days of being notified.
• new six monthly reports from sponsors – covering supply data, details of all adverse events, and all complaints, both in Australia and world-wide.
• the risk of BIA-ALCL must be included in clinicians’ Instructions for Use of all breast implant and tissue expander devices.
• patient information leaflets must include warnings about the risks of BIA-ALCL.

What are the additional clinical data conditions (marked with an *)?

The sponsor of these ARTG entries must provide to the TGA, by 1 July 2020 with:

• immunotoxicology studies, and
• updated risk assessment documentation and processes with appropriate hazard controls implemented.

What is a ‘legacy implant’?

Legacy implants are breast implants that women may have had implanted, but are no longer available. This could be for various reasons; for example, the company may have removed them from the market themselves, or the TGA may have cancelled them for other reasons such as manufacturing concerns. Not all legacy implants are listed here, only those which Australian consumers may still have implanted. Breast implants are not a life-time device and are designed to be replaced every 10 to 15 years.