Current status of breast implant products in Australia

In 2019, we commenced a post-market review of all breast implants included in the Australian Register of Therapeutic Goods (ARTG) in response to the increasing number of cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

The review included laboratory assessment of all implants supplied in Australia and statistical analysis of supply information and cases of BIA-ALCL. 

The laboratory report is available on the TGA website.

This webpage details the steps we took to improve the safety of breast implant products in Australia and actions taken as part of this post-market review.

Current status of breast implants previously supplied or being supplied are outlined in the table below. 

These include:

• Cancellation (removal) of devices from the ARTG (by the TGA or the Sponsor); or
• Imposition of Conditions of Inclusion (COI) on the devices in the ARTG.

Where a device has been cancelled from the ARTG, this means no new patients will receive these devices and they can no longer be supplied in Australia.

To ensure the highest level of patient safety possible, we have imposed 'conditions' on all breast implants that remain available in Australia. 

This means that for a sponsor to continue supplying a device in Australia, they must meet a range of requirements. 

These conditions are also imposed on all new breast implant included in the ARTG.

A condition can impose further requirements as seen appropriate to support the safe ongoing use. 

The conditions enable us to closely monitor the devices overtime and take action promptly if any issues are identified.

Conditions imposed

• All cases of BIA-ALCL must be reported to the TGA within 10 days of being notified.
• Sponsors are required to provide six monthly reports 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.

Legacy implant

1. Legacy implants are breast implants that women may have had implanted but are no longer available.
2. 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.
3. 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.

The table below outlines the current status of breast implant devices in Australia.