The Therapeutic Goods Administration (TGA) has decided to take regulatory action in relation to all breast and implant expanders sold in Australia.
There are three levels of action that are being taken:
1. Suspension and recall – some breast implant devices have now been entirely suspended, meaning that these implants will no longer be available on the Autralian market for at least the next six months. During this six month period the TGA is asking that the sponsor provide supporting documentation to prove the efficacy and safety of the devices.
Suspended impants are those that are ‘macrotextured’ or graded at a level 3 or 4, and some ‘microtextured’ implants associated with higher incidences of BIA-ALCL and other medical concerns.
2. Conditions apply – New conditions for inclusion in the ARTG has been imposed on breast implant devices and tissue expanders that remain available for use by a patient. As a result, sponsors now have an increased responsibility to patient and practitioner education, and are required to report adverse events, including BIA-ALCL within 10 days of learning of any new cases.
3. Removed from market – In some cases, the sponsor has chosen to cancel inclusion of their implant during the review process.
It is important to note that despite the above TGA update, cases of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is incredibly rare.
Evidence-based recommendations are that the removal of a breast implant is not required in a person who displays no symptoms or concerns. If you are worried however, and detect any symptoms such as armpit swelling, a lump or pain, we recommend you seek medical attention as a priority.
The Therapeutic Goods Administration (TGA) has conducted a thorough review of breast implants sold in Australia and has taken a range of regulatory actions to address BIA-ALCL risks.
The breast implant hub has information to support people with any concerns about their implants, or those considering implants. A range of textured and smooth implants and tissue expanders remain available in Australia.