What is the ABDR?
The Australian Breast Device Registry (ABDR) is a public health registry that records information about breast device surgery in Australia. Funded by the Commonwealth Department of Health, the ABDR addresses the lack of reliable and sound data to accurately measure health outcomes after implantation of breast devices (such as breast implants, breast tissue expanders and associated meshes, including acellular dermal matrices).
Participation in the ABDR promotes optimal patient health. The ABDR aims to identify and report on possible trends and complications associated with breast device surgery, such as rates of revision surgery. Reports to health agencies may include information on surgical techniques and practice to help identify where treatment gaps may exist and its effect on patient outcomes. In this way, the ABDR may facilitate best practice for health care professionals and health care facilities caring for patients receiving breast implants. Individual patients in the ABDR will never be identified in public reports and a consumer advocate (Consumers Health Forum of Australia) represents patient interest on the ABDR Steering Committee.
For many people, the ABDR helps provide peace of mind that devices are being tracked long-term for adverse effects.
Why participate in the ABDR?
- Your participation in the ABDR contributes to long term safety monitoring of implanted breast devices with an aim to improve patient safety
- Safety issues can be identified in significantly shorter timeframes than in the past
- You will have access to a record of your device details upon request (medical records only need to be kept for seven years)
- Helps provide confidence that your devices are being monitored for health issues
- All health information is held in a highly secure database that is housed within Monash University
- It’s easy to be in the registry. If your surgeon/clinician contributes to the ABDR at the time of your surgery, details of your device and procedure will automatically be included in the ABDR
- Information included in the registry helps track and monitor breast devices for adverse health effects
Hazard Alerts: A key task of the ABDR is to report on implant safety and performance; devices are being tracked and monitored for adverse health effects. Poorly performing devices will be reported to the Therapeutic Goods Administration (TGA), a part of the Department of Health that regulates and approves medicines, sunscreens, vitamins and minerals, blood and blood products and medical devices, for assessment and follow up. The TGA will work with the relevant sponsor/manufacturer to determine a response.
One notable device recall, which led to the formation of the ABDR, occurred on 31 March 2010. The French medical device regulatory authority (AFSSAPS) ordered Poly Implant Prosthèse (PIP) to recall silicone implants due to a reported higher rate of incidents (majority ruptures) compared to other silicone implants over the same five year time period. In Australia, the TGA recommended that recipients of PIP devices undergo clinical examination with an ultrasound and that practitioners unable to identify rupture or suspected rupture of the devices refer the patient for explant (removal) and/or replacement. Unfortunately, only around 30% of Australians estimated to have PIP devices were able to be contacted about the issue.
The ABDR stores patient’s contact details and device details over the longer term to:
Facilitate communications: In 2019, the TGA issued a Hazard Alert for highly textured breast devices linked to Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare cancer of the immune system. The ABDR was able to provide requesting healthcare providers a list of patients under their care for follow up.
Contribute to better health for future recipients of breast devices: Although breast devices are widely used, the TGA still considers implantable breast devices to be ‘high risk’. Health information from participants in the ABDR contributes to reports that will help safeguard the health of recipients undergoing breast device surgery, such as for cosmetic breast augmentation and breast reconstruction (for breast cancer) and congenital anomalies.
Give access to information: Participants in the ABDR will be able to access information about their breast device, which may be useful for those needing a revision, experiencing complications, seeing a new surgeon/clinician, or the last visit was more than seven years ago (medical records are required only to be stored for seven years).
The ABDR stores patient contact details and information about the device surgery (or surgeries) in a highly secure database, housed within Monash University. Personal information, such as your name and contact details, are kept by the registry only to ensure information about your surgery/breast device can be validated. We need these details for verification purposes should you request information about your device, and for possibly, sending you a short follow up questionnaire. We do not release any personal information other than to your surgeon/clinician or your healthcare facility. Your details may be linked with state/national health and death registries to ensure the information we hold is accurate and complete, or for research purposes. Non-identifiable data may also be provided to researchers upon request and following appropriate ethics approval. This data is grouped and all identifiable details including names, date of birth, Medicare and hospital UR numbers are removed.
How to become involved in the ABDR
If you are a patient and would like to be included in the Australian Breast Device Registry (ABDR), ask the doctor, who is performing the surgery, whether or not they are contributing to the ABDR. If he/she does contribute to the ABDR at the time of your surgery, you will automatically be included.
Your doctor 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 a registry?
From 6 May 2015, the BIR (a precursor to the ABDR) ceased to register new patients. However, 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 bir@plasticsurgery.org.au or call (02) 9437 9200 or go to this website.