In collaboration with Monash University’s Department of Epidemiology and Preventative Medicine, the Australasian Foundation for Plastic Surgery Limited (the Foundation) has developed a world’s best practice Breast Device Registry (BDR). The BDR is currently being piloted in 3 sites across Australia.
There is strong international interest in the Australian BDR (ABDR) and agreement around an international minimum data set is gaining momentum.
Download Monash University’s ABDR update, December 2015.
With Rod Cooter’s permission, his presentations on both ICOBRA and the ABDR are available for download from these links:
In July 2014, the Federal Government awarded the tender to run a new opt-out clinical quality breast device registry to Monash University. The $2m in funds is for an 18 month period to implement the national roll-out. In the longer term, ongoing funds are secured through the TGA.
Over the next few months, our old breast implant registry will be superseded by the new Australian Breast Device Registry. We’ll advise members and patients of the new arrangements in due course. For now, you can continue to submit the old BIR forms.
The vision for a better registry was sustained by sheer hard work done by the Foundation, ASPS, and especially Rod Cooter, over the last 4 years to build a world’s best practice clinical quality breast registry. Its success is a tribute to Australian ingenuity and ‘can do’ attitude.
Report from the ASPS Chief Executive
The new Breast Device Registry (BDR), with initial development funds contributed by the Australasian Foundation for Plastic Surgery (the Foundation), has been welcomed by the Presidents of the national plastic surgery societies which have an agreement with the American Society. Australia was the first national society to sign a memorandum of understanding (MOU) with the American Society. There are now 14 member countries which comprise the Global Leadership Forum. The Global Leadership Forum met prior to the recent American Conference in New Orleans in late October. The Netherlands Society has already adopted our new Breast Device Registry with several more countries, such as Brazil and Taiwan, showing keen interest to duplicate it in their respective countries. The FDA and the UK Government are also considering the merits of replicating our BDR following several consultations between Rod Cooter and those authorities over the past 18 months.
By invitation, Rod Cooter also addressed the formal conference as part of the ‘President’s Panel’ which focused on implants and registries. While national societies and government authorities may differ in terms of the final design of a breast device registry appropriate for each national situation, flowing form Rod’s tireless work, there is now international agreement for the collection of a minimum data set which will enable efficient analysis internationally comparable data. This level of comparable data was absent during the PIP situation. Developed and tenaciously driven by Rod Cooter, the Foundation’s ICOBRA project (International Collaboration of Breast Registry Associations), is now the symbol of an international movement to establish a common minimum dataset for breast device registries.
The American Society will not host the Global Leadership Forum in 2013. Instead, for the first time, the Global Leadership Forum will be hosted by the Australian and New Zealand Societies at our PSC in April 2013, Melbourne. It provides the opportunity for a formal ceremony and symbolic signing of the international dataset and the official launch of ICOBRA.
In Australia, there is agreement from all stakeholders including government, TGA, regulators, clinicians and industry, that our new Breast Device Registry meets the recommendations arising from the Senate Committee’s recent inquiry into PIP. The new BDR is best practice, opt out, and endorsed by all stakeholders as the only official national breast device registry in Australia incorporating both contact and outcome tracking data. Recommendations from the report of the three pilot sites have been incorporated into the BDR form in readiness for a national roll-out.
Download Rod Cooter’s presentation to BAPRAS, Newcastle-upon-Tyne, July 2012.
At the 9 November Council Meeting of the Australian Society of Plastic Surgeons, the Council resolved to formally adopt the International Collaboration of Breast Registry Activities (ICOBRA) as a Society activity. Download Geoff’s message (Nov 2013).