Australian Breast Device Registry set to improve implant safety

Australian Breast Device Registry set to improve implant safety

8 February 2017, 2:02PM
Royal Australasian College of Surgeons (RACS)

Critical data collected from the Australian Breast Device Registery (ABDR), rolled out in 2015 to replace the earlier Breast Implant Registry (BIR), is on track to achieve the greatest levels of reliability required to transform breast device safety for women in Australia, according to an article in the latest issue of the Australia and New Zealand Journal of Surgery (ANZJS), the peer-review publication of the Royal Australasian College of Surgeons (RACS).

With the poly implant prothese (PIP) crisis of 2001, when it was discovered that non-medical grade silicone used in breast implants was associated with increased rupture rates, the former Breast Implant Registry (BIR) had only been able to capture 3.4 per cent of the implants used in the 12,000 potentially affected women.
 
The article refers to the BIR as ‘disjointed and cumbersone’ and questions its ability to accurately qualify reported cases, hospital discharge rates and individual record quality.
 
According to the story the ABDR enables any surgeon using breast implants or other devices such as tissue expanders, to contribute data, and the data collection form can be completed within two minutes at the time of operation.
 
Additionally, the ABDR has adopted an opt-out consent from eligible patients at no cost. Compared to the BIR, which was a voluntary patient-funded registry, the free opt-out option ensures that important data is collected.
 
Since August 2016 less than one per cent of participants have opted out of the registry, which represents data from more than 7800 patients, and 45 per cent of known surgeons contributing to the registry.
 
The ABDR has been endorsed by the Australasian College of Cosmetic Surgeons, BreastSurg ANZ and the Australian Society of Plastic Surgeons, as well as the Royal Australasian College of Surgeons, which recently recognised the ABDR as an audit activity for professional development.
As the registry matures and more data is collected, more information will become available on device complications and revisions.
 
New cases can be collated, studies may be conducted on specific cases, and with the collaboration of the Therapeutic Goods Administration product recalls conducted.
 
The ABDR is funded by the Commonwealth Government and has established robust governance and quality systems and according to the article, is on track to achieve the very high levels of date capature and reliability required to transform breast device safey for Australian women.
 
Read the full article here

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