Project overview
The TGA works with subject matter experts in clinical practice and academics in the field on particular devices of concern. We include consumers in these expert working groups to bring their experience to the table and to ensure consumer perspectives are heard and considered.
Consumer representation on expert working groups
Breast Implant Expert Working Group
The Breast Implant Expert Working Group was established in 2016 following reports of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). The group provides clinical advice to the TGA on breast implants and tissue expander medical devices.
Membership includes a consumer representative, in addition to health professionals, and academic representation.
A Breast Implant Consumer Working Group was also convened in 2019 to provide insights and advice from a diverse lived consumer perspective.
The two working groups have supported the development of the TGA’s breast implant hub and its content which includes safety communications and guidance to support consumers and health professionals.
Surgical Mesh Expert Working Group
The TGA convened the Surgical Mesh Expert Working Group in October 2021 to support the TGA’s up classification of surgical mesh devices from medium-to-high risk (Class IIb) to high risk (Class III) devices. The expert working group comprises government representatives, clinicians representing peak urogynaecology-related health professional bodies, academics, and a consumer representative.
The Surgical Mesh Expert Working Group advised on the mesh devices being up classified and supported communication pieces to inform health professionals on the progress of up classification, and on devices that did not meet requirements and were withdrawn (cancelled) from the market.
Ventilator Expert Working Group
The Ventilator Expert Working Group was established in 2018 to support the TGA’s product safety review of intensive care ventilators. The expert working group comprises clinicians, scientists, biomedical engineers, government representatives, including from state and territory health departments, and a consumer representative.
The Ventilator Expert Working Group has supported the TGA’s response to Philips’ recall action for their CPAP, BiPAP devices and mechanical ventilators, including a public awareness campaign to ensure consumers are aware of and respond appropriately to this recall action.
Further information
More information on the TGA’s Action Plan for Medical Devices is available at Medical device reforms.