TGA statement on breast implant & cancer link

December 20, 2016

Breast implant cancer link supports need for extended device monitoring

Today’s Australian Department of Health statement on breast implant-associated anaplastic large cell lymphoma (ALCL) underscores the importance of tracking the long-term safety of implanted breast devices.

The federally funded Australian Breast Device Registry (ABDR), which is led by Monash University and currently being rolled out, is a national database that captures and monitors health outcomes of breast devices — breast implants, breast tissue expanders and acellular dermal matrix.

Head of Drugs and Device Registries at Monash University, Dr Ingrid Hopper, said patient well-being was the foremost priority for the clinical quality registry.
“The ABDR will provide surgeons and patients peace of mind that the long term safety and performance of breast implants are being monitored and tracked,” said Dr Hopper.
“The registry is purpose-designed to monitor trends and health patterns associated with breast device surgery and help surgeons benchmark optimal surgical techniques.”

All craft groups performing breast device surgery; Australian Society of Plastic Surgeons (ASPS), Australasian College of Cosmetic Surgery (ACCS) and Breast Surgeons of Australia & New Zealand Inc. (BreastSurgANZ) are endorsing the ABDR.
Additional stakeholders include: the Therapeutic Goods Administration (TGA); Commonwealth Department of Health; Australian Commission on Safety and Quality in Healthcare; Consumer Health Forum of Australia; and the Medical Technology Association of Australia ensuring full industry and health representation on the registry.

More than 300 surgeons are currently contributing surgical details of breast device surgery from 200 sites across Australia. The 10,000th patient recently enrolled in the ABDR. Less than 1 per cent of patients opt-out of the registry.
The TGA issued the statement and recommendations today in response to more confirmed cases of the rare anaplastic large cell lymphoma in Australia.
An estimated 20,000 Australian women annually are thought to receive implantable breast devices.

The ABDR encourages anyone considering having breast implants to check that their surgeon is participating in the registry. Surgeons wishing to be involved in the ABDR should register their interest on 03 99030205 or email
Read the TGA statement here.