TGA response to federal court decision on urogynaecological mesh class action

The Therapeutic Goods Administration (TGA) notes the outcomes of the class action against Johnson & Johnson. We will closely consider the judgement including any further improvements that could enhance the regulatory system in Australia.

Our review of urogynaecological mesh devices in 2017-18, resulted in the cancellation of a number of devices from the Australian Register of Therapeutic Goods. Since that time the TGA has worked closely with the Australian Commission on Safety and Quality Health Care and State and Territory Health Departments to provide improved services and information to affected women.

In addition the TGA has already made improvements to its processes to:

• simplify the consumer reporting process,
• investigate data sharing options with State and Territory Health Departments to increase reports received by the TGA so that we can act more promptly,
• strengthen post-market monitoring of devices already in use with additional conditions of inclusion for all urogynaecological meshes,
• require patient implant cards and patient information leaflets for all implantable devices to increase consumer awareness,
• held workshops with consumers to co-design a range of improvements to enhance consumer awareness,
• commenced consultation on establishing a unique device identification system in Australia, to facilitate the identification and tracking of medical devices.