The Australian Government will take sweeping steps to deal with the adverse effects of transvaginal mesh implants in its response to the Senate Inquiry.
The inquiry raised awareness about serious and longstanding impacts reported by some women following mesh-related procedures.
I acknowledge the strength of the women who spoke at the public hearings, recounting deeply private and often traumatic experiences.
The inquiry identified how we can recognise and support the women affected, and make improvements to Australia’s health care system.
The Government has carefully considered the 13 recommendations and today tabled its response.
The Government supports, or supports in principle, 12 of the 13 recommendations, and notes Recommendation 11 which calls for a retrospective audit of transvaginal mesh procedures since the devices were introduced in Australia.
Many of the Senate committee’s recommendations require collaboration and action by federal, state and territory governments, health practitioners, professional medical colleges, the Therapeutic Goods Administration (TGA), the Australian Commission on Safety and Quality in Health Care and the medical device industry.
Our main aim and collective efforts are focused on restoring affected women’s confidence in our healthcare system, now and into the future.
I have written to state and territory health ministers seeking their cooperation to implement recommendations that extend beyond the direct responsibility of the Commonwealth.
The Commonwealth Chief Medical Officer will also write to relevant health professionals seeking their support.
In the meantime, the Morrison Government is already taking action by:
- improving patient information – device companies will be required to supply leaflets and cards with details of each device implanted
- strengthening pre-market assessment by up-classifying all surgical mesh products from class IIb (medium to high risk) to class III (high risk)
- enhancing post market surveillance to make it easier to report adverse events to the TGA
- introducing new Medicare Benefits Schedule items for the surgical repair of pelvic organ prolapse and removal of mesh
- introducing a range of resources developed by the Australian Commission on Safety and Quality in Health Care to guide clinical practice
- launching the new TGA web hub as a central point for consumers and health professionals to find information on transvaginal mesh.
Australians deserve and expect a high quality healthcare system. The Morrison Government is committed to a system that is professional, that ensures informed consent by patients and delivers better health outcomes.
The Australian Government’s full response to the Inquiry is on the Health Department’s website.