Medical device reforms: consumer representation on expert working groups

Project overview

For medical devices of concern, we work with clinical practice experts and academics.

We include consumers in these expert working groups to Bring their experience to the table and to ensure consumers' voices are heard.

Consumer representation on expert working groups

Breast Implant Expert Working Group (BI-EWG)

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 on breast implants and tissue expander medical devices.

Membership includes a consumer representative, as well as 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 working groups supported the development of the TGA’s breast implant hub. Its content includes safety communications and guidance to support consumers and health professionals.

Surgical Mesh Expert Working Group

We convened the Surgical Mesh Expert Working Group in October 2021 to support our re classification of surgical mesh devices from being medium-to-high risk (Class IIb) to high risk (Class III) devices.

The group comprised of 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 that were being up classified. They supported communication to inform health professionals of the changes.

Ventilator Expert Working Group

The Ventilator Expert Working Group was established in 2018. It supports the TGA’s product safety review of intensive care ventilators and sleep apnoea devices.

The group comprises clinicians, scientists, biomedical engineers, government representatives, including from state and territory health departments, and a consumer representative.

The group supported Philips' recall of CPAP, BIPAP, and mechanical ventilators. As part of this recall, we ran a public awareness campaign to improve consumer awareness.