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Australia’s breast implant risk management framework | TGA

Australia’s Breast Implant Risk Management Framework coversheet

Associate Prof Magdalena Simonis AM participated in the Breast Implant EAG with Therapeutic Goods Administration (TGA). The EAG produced the Australia’s Breast Implant Risk Management Framework.

 “We take a proactive approach in monitoring the potential impacts of all types of breast implants including the newer models. We aim to minimise implant related hazards, detect any adverse effects early, and take regulatory action quickly if needed. This framework outlines our processes to identify and manage risk. It contains useful information on what consumers and health care professionals can do to be vigilant. It describes the cooperative efforts that could be used by health care professionals, experts in the field, international regulators and consumer advocates in the on-going monitoring and gathering of real-world evidence. “

Download the Document

Australia’s Breast Implant Risk Management Framework (pdf)


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