What is the ABDR?
The Australian Breast Device Registry (ABDR) is a Commonwealth-funded Monash University-led health initiative that records health data relating to breast device surgery. The registry is designed to track patient health outcomes, monitor the long-term safety and performance of breast devices and benchmark the quality of surgery involving breast implants, breast tissue expanders and acellular dermal matrices. The ABDR:
- Provides progressive reports, using validated data, to key stakeholders such as surgeons, hospitals, the TGA (Therapeutic Goods Administration) and Department of Health
- Helps provide recipients of breast devices peace of mind that the product is being tracked and facilitates quicker communication in the event of a hazard alert
- Is the first registry in the world to have the support of all surgical craft groups: The Australian Society of Plastic Surgeons (ASPS), Australasian College of Cosmetic Surgery and Medicine (ACCSM) and Breast Surgeons of Australian & New Zealand Inc. (BreastSurgANZ) to develop and implement a registry
- Is conducted by Monash University’s School of Public Health & Preventive Medicine
- Is an opt-out registry to maximise data representation
About Data Collected by the ABDR
The ABDR collects information about breast devices using a simple data collection form (DCF) completed by surgeons at the time of surgery. We aim to collect data related to all surgical procedures involving breast implants, breast tissue expanders and acellular dermal matrices (or similar) undertaken nationally. This include insertions, revisions of in situ devices, and explants without replacement. Information from the DCFs will generate a powerful set of accurate and validated data that can be analysed and reported to individual surgeons, hospitals, the department of health and other key stakeholders. The ABDR will facilitate, for the first time, information on device failure rates, complications and revision rates of procedures involving breast devices nationally.
Additional to data collected at the time of surgery and revision surgery, the ABDR will ask patients brief questions about their health at 1, 2, 5, 10 years post-surgery. Called PROMs (Patient Reported Outcome Measures), the questions are being successfully rolled out.
The ABDR sincerely thanks surgeons and patients contributing to the ABDR. It is their commitment to the ABDR that is helping to safeguard the health of past and future patients undergoing breast device surgery.
A full list of data items collected by the ABDR can be found here.
Information Contributing Surgeons Provide to the ABDR
Surgeons complete these details on the Data Collection Form (ABDR) for inclusion in the registry:
- Patient details: name and date-of-birth, address and contact details (these details, which are never released to the public, are important for follow up with the patient’s surgeon where necessary and enable the patient to be contacted, eg by their health provider, in the event of a hazard alert)
- History (reason for operation, type of operation)
- Details of the device implanted or explanted (type, serial number, manufacturer etc.)
- Operative notes (details of the incision site, plane of implantation, intraoperative techniques used etc.)
- If applicable: details related to removal or replacement of a previous device (reason for revision, issues identified at revision)
Why is the ABDR so important to public health?
It is estimated 20,000 women undergo breast device surgery in Australia annually. In most cases, breast device surgery is undertaken for breast augmentation, reconstructive surgery e.g., post mastectomy, and to correct congenital deformities.
There is long-standing worldwide debate regarding the safety of breast devices (breast implants, breast tissue expanders and acellular dermal matrices) and their impact on the health and well-being of recipients. Only a national registry with epidemiologically sound data will accurately measure device performance after implantation. The establishment of the Australian Breast Device Registry will facilitate real world knowledge on the safety of the devices and has the potential to significantly improve outcomes for patients with implantable breast devices.
Monash University leads the ABDR, storing data within a highly secured database. The registry independently generates objective, validated data for reports to stakeholders, such as surgeons, the department of health and the TGA. Reports may include information on best health outcomes and surgical practice, where treatment gaps may exist and its effect on patient outcomes, and facilitates quality improvement. For patients with breast devices, the ABDR has surgery details upon request, i.e., when changing surgeons, and may help provide peace of mind that the safety of devices are being tracked long-term.