TGA information resources
Update on suspended breast implant devices
29.10.2020 Australia’s device regulator, the Therapeutic Goods Administration (TGA) today announced three breast implant devices that were suspended in May this year pending review, are now cancelled. The authority advised on their website: “Even if your breast implants are being cancelled, suspended or recalled, medical experts do not recommend removing them if you do not have symptoms of BIA-ALCL. This is because BIA-ALCL is very rare, and the risk of undergoing surgery could be higher than the risk of developing BIA-ALCL.” The TGA’s breast implant hub has information to support people with any concerns about their implants, or those considering implants. Additional information regarding the TGA’s safety and performance concerns about the suspended breast implants is also available to assist health professionals in making informed decisions.
8.05.2020 The TGA advised that following a review of breast implant devices, five products have been cancelled while three are suspended from use for a further six months. This action only applies to devices which have not been implanted. The TGA advises on their website: “If you have any of the above breast implants, you do not need to do anything except be aware of the symptoms of BIA-ALCL and seek advice from a health professional if you notice any changes.” Suspended and cancelled devices cannot be supplied, imported or exported from Australia without special authorisation. The TGA’s breast implant hub has information for people with concerns about their implants (or considering implants). Information about BIA-ALCL, a rare form of cancer of the immune system is here.
View TGA webinars on BIA-ALCL and breast devices
10.03.2020 As part of the TGA’s work to provide the Australian public with up to date information on breast implant associated anaplastic large cell lymphoma (BIA-ALCL), last month ABC medical journalist Sophie Scott facilitated two webinars:
16.01.2020 View the TGA Q&A video on BIA-ALCL (Breast Implant Associated – Anaplastic Large Cell Lymphoma) for the Australian public. Read video transcript and other relevant information on the TGA Breast Implant Hub.
26.09.2019 Today the TGA suspended supply of eight models of breast implants for six months, as a precaution until safety and performance concerns with the devices are addressed. Manufacturers of all 31 models of textured and smooth devices which have not been suspended, must comply with several conditions outlined by the TGA here. The TGA website advises: “As BIA-ALCL is very rare, the consensus clinical advice is that the removal of breast implants is not required in a person who has no symptoms or concerns. Patients who have breast implants, or have previously had breast implants should regularly check their breasts and see their doctor if they notice any changes or have any concerns.” (Read media release here.)
The TGA has a dedicated Breast Implant Hub for easy to read information to support people with concerns about their implants or considering implants.
View the consumer fact sheet in the wake of Allergan’s decision to recall un-implanted macro-textured breast implants and tissue expanders, “due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system.” <https://www.tga.gov.au/consumer-fact-sheet-recall-allergan-biocell-breast-implants>
The TGA suggests that the surgeon who did your breast implant surgery, is best placed to advise you about the type of device that was implanted. If your surgery was undertaken in a public hospital then you can contact the hospital to request the information from your medical records, if it has been recorded there. The ABDR may also have details of your breast device (if you were included in the registry between 2012 and now).
The TGA has a dedicated Breast Implant Hub for easy to read information to support people with concerns about their implants or considering implants (including where to go for help and things to consider before having the procedure). TGA’s Recall of Allergan Biocell breast implants and tissue expanders FACT sheet explains what you should know if you have implants.
How to become involved in the registry
If you are a patient who would like to become involved in the Australian Breast Device Registry (ABDR), you may speak to your surgeon and enquire as to whether or not they are contributing to the registry. If your surgeon is contributing, you will automatically be included.
Your surgeon will discuss the ABDR with you prior to surgery and provide you with a copy of the ABDR Patient Leaflet. After surgery you will receive a more detailed Patient Explanatory Statement in the post. If you would like to receive a copy of this statement prior to deciding to participate in the registry or would like to receive this by email, please contact the ABDR Tel. (03) 9903 0205.
Already involved in the breast implant registry (BIR)?
From 6 May 2015, the BIR ceased to register new patients. However, the Australian Society of Plastic Surgeons (ASPS) continues to maintain the Breast Implant Registry (BIR) legacy data and to administer patient access to the unique data stored on the Registry. If you have questions about your participation in the BIR, please contact email@example.com or call (02) 9437 9200 or visit this website.