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 will address 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 acellular dermal mesh).
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 surgeons 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 provides 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
- You and your surgeon can be made aware of safety issues in significantly shorter timeframes
- You will have access to a record of your surgery 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 (bank level), independent data base at Monash University
- Participation is easy
- You can participate as much or as little as you wish, e.g. complete short follow up questionnaires and report complications to the ABDR
- Or use the ABDR as a ‘set and forget’, secure in the knowledge that your device is being tracked and monitored for adverse health effects
- Download a brochure here
Alerts and recalls through the ABDR: 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 approximately 30% of Australians estimated to have PIP devices were able to be contacted about the device’s failure.
The ABDR stores patient’s contact details and device details creating a ‘set and forget’ health initiative that helps provide peace of mind participants in the event of a product recall.
Contributing to better health for future recipients of breast devices: Although breast devices are increasing in popularity, 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 breast augmentation, risk reducing mastectomies, breast reconstruction (following breast cancer) and developmental deformities.
Access to information: Participants in the ABDR will be able to access information about their surgery, which may be useful for those needing a revision, experiencing complications, seeing a new surgeon, or the last visit was more than seven years ago (medical records are required only to be stored for seven years). In addition, patients can contact the ABDR to report any complications at any time.
It is important to note that ABDR personnel store patient contact details and information about the surgery (or surgeries) in a highly secure database (equivalent to bank data security). Identifiable information of any person or organisation will never be shared, other than with your surgeon and state/national death registries and government health records (on operations performed in hospitals) to ensure information in the registry is accurate and complete. ABDR personnel must comply with national and local privacy legislation and codes of practice. Public reports arising from the registry will never contain any identifiable information about you and information used in analyses will be coded (‘re-identifiable’).
How to become involved in the ABDR
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 Coordinator on (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 email@example.com or call (02) 9437 9205 or visit this link: http://www.plasticsurgery.org.au/protecting-patient-safety/new-australian-breast-device-registry-abdr/