Australian Breast Device Registry: breast device safety transformed

It has been 6 years since news broke of the poly implant prothese (PIP) implants crisis, in which non-medical grade silicone was used in breast implants and was associated with an increased rupture rate. This led to a worldwide recall of non-implanted PIP implants, and a programme of mass explantation in some countries. In Australia, the voluntary, patient-funded Breast Implant Registry (BIR), established in 1998, was estimated to have captured only 3.4% of the PIP implants used in an estimated 12 000 women. An ensuing enquiry by the Australian Senate into the use of medical devices including specifically PIP breast implants, recommended establishing an opt out registry for breast implants as a priority. The aims of such a registry were to address the recognized deficiencies of the BIR and included: • Compliance with clinical quality registry standards and operating procedures established in 2008 • Complete registry capture of breast device procedures undertaken in Australia and their complications • Sufficient data quality and reliability to address high risk circumstances such as device recall and potentially serious complications • Surgeon review of their own data and outcomes • Benchmarking of process and outcome indicators The Australian Breast Device Registry (ABDR) was established in pilot form in 2011, and commenced national roll out in 2015. The ABDR is a clinical quality registry, compliant with the Australian Commission on Safety and Quality in Health Care Operating Principles. The registry design addresses the major weaknesses of its predecessor, the BIR, in a number of important ways. The BIR data collection was disjointed and cumbersome. The ABDR collects a core data set which is epidemiologically sound through being simple, objective and reproducible. The data collection form can be completed within 2 minutes at the time of operation. Obtaining patient consent and a cost of $25 per implant were major barriers for patients entering the BIR. The ABDR has adopted opt out consent meaning that data can be collected from all eligible patients once their surgeons and hospitals are participating in the registry, at no cost to patients. Reliability of the data is ensured by high levels of registry participation, data completeness and quality. As of August 2016, less than 1% of participants have opted out of the registry, meaning that over 99% of eligible patients at participating registry sites are retained, reflecting data from over 7800 patients and over 8600 procedures. Compared with the BIR which had no audit process, the ABDR is establishing quality measures to ensure the robustness of the data, including (i) validation of case ascertainment by regular comparison of reported cases with relevant hospital discharge codes; and (ii) limited medical record audits to ensure individual data record quality. Any surgeon using breast implants or other devices, such as tissue expanders, can contribute data, unlike with the BIR, which was restricted to plastic surgeons. The initial legacy of this is that plastic surgeons currently form the bulk of the surgeons contributing data. Yet as the ABDR has been endorsed by all of the major craft groups (including the Australasian College of Cosmetic Surgeons, BreastSurg ANZ and Australian Society of Plastic Surgeons), and both the Royal Australasian College of Surgeons and Australasian College of Cosmetic Surgeons have recently recognized the ABDR as an audit activity for continuing professional development, the ABDR has recently seen an increase in participation by cosmetic surgeons. However, the number of surgeons who are not registered with these organizations is unknown, presenting a significant challenge to obtaining the projected 95% of surgeons required for highquality data capture. As of August 2016, we estimate that 45% of known surgeons are contributing to the ABDR. Funding for the ABDR is provided by the Commonwealth Government, and it is housed within the Department of Epidemiology and Preventive Medicine at Monash University, an independent academic organization. The ABDR has a collaborative governance model, with deliberately broad representation on the steering committee, including academia, government, craft groups, industry and consumers. The steering committee approve applications for clinical research derived from registry data in accordance with the registry data access policy. The data outputs generated by the ABDR will help to guide breast device surgery clinical practice and improve the quality of patient care. Site-level reporting of registry data has commenced, using comparative data from the greater ABDR database. Risk-adjusted benchmarking will be incorporated in outcomes reporting, and clinical indicators are being developed to facilitate this at the surgeon level, and also at the device level. An outlier policy will come into effect as the database matures. Work is being undertaken to allow individual surgeons to review their own data and outcomes in real time. Patient reported outcome measures based on the internationally recognized BREAST-Q questionnaire are being piloted to incorporate into the outcome measures. Establishing a national registry such as the ABDR requires time. As the database matures more information will become available on complications and revisions, including by device. These data will become richer and better able to inform clinical practice. The minimum dataset was formulated through an international collaboration to enable data harmonization and outcomes amplification in the future. The ABDR is assisting with the development of a