Monash University medical device registry milestone

Breast Device Registry closer to national reports on breast implants

Monash University’s Australian Breast Device Registry (ABDR) reached a new milestone, enlisting around 90 per cent of eligible surgeons to help track the long-term safety of implantable breast devices in Australian patients. However, researchers are calling for more surgeons to give full national representation.
The milestone comes at a time when post market surveillance of medical devices is under increasing public scrutiny.

Every year an estimated 20,000 Australians have breast devices implanted for breast augmentation, risk-reducing mastectomies, breast reconstruction, or to correct developmental deformities. Monash School of Public Health and Preventive Medicine ABDR Project Lead, Dr Ingrid Hopper said the health and wellbeing of Australians was at the centre of the registry.

“With the number of these surgeries rising worldwide, it is increasingly important that we track and report on potential trends and complications associated with breast devices, as well as identify surgical techniques that give patients the best outcomes,” said Dr Hopper.

The registry produces anonymised public reports on complications and revision rates for all devices, such as breast implants, breast tissue expanders and acellular dermal matrices/mesh, and will be the primary point of contact for reporting ALCL, a rare and largely treatable form of cancer of the immune system linked to breast implants.

More than 450 plastic surgeons, general breast surgeons and cosmetic surgeons across Australia are contributing data to the project. Approximately 1000 new patients join the ABDR every month, with more than 34,000 patients currently enrolled in registry.

Dr Hopper said that while breast implants are one of the most carefully studied of all medical devices, recent cases of ALCL worldwide shows there is still a need to monitor implanted devices to detect rare and unanticipated complications.
“Having 90% of eligible doctors signed up to participate in the ABDR is a significant step towards improved patient safety and best practice in Australia,” said Dr Hopper.
“We do need all Australian doctors implanting breast devices to be in this important public health initiative to derive maximum benefit for their patients.”

The Commonwealth funded registry is supported by surgical societies, the Australian Society of Plastic Surgeons (ASPS), the Australasian College of Cosmetic Surgery (ACCS) and Breast Surgeons of Australia and New Zealand Inc (BreastSurgANZ).

The registry, which was set up in 2015, facilitates direct contact with surgeons and patients in the event of a hazard alert from the regulator, the Therapeutic Goods Administration.

The ABDR is also at the forefront of a collaboration of international breast implant registries working to share findings for early detection of problems.

(NB: updated 31.01.2018)