Medical devices safety
The safety and performance of medical devices is continuously monitored. Approved devices must continue to meet all the requirements of their approval.
- Breast implants: Report of squamous cell carcinoma and various lymphomas in scar tissue around breast implantsOn 8 September 2022, the US Food and Drug Administration issued a safety communication about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants.
- Acellur Dermal Matrix Products used in Breast Reconstruction - clarification on reports of potential higher complication rates.
- Medical device safety update regarding pulse oximeters limitations, including the effect of skin pigmentation.
- An overview of the information that will be provided in patient information leaflets and patient implant cards for permanently implantable medical devices
- In the past 12-18 months, the TGA has implemented a number of changes in an effort to increase and improve post-market monitoring and surveillance activities
- Final Report on the Australian Government Response to the Recommendations of the Senate Community Affairs References Committee ReportThe Australian Government remains committed to the safety, health and wellbeing of all Australians.
- Progress report: Australian Government response to the Senate Community Affairs References Committee reportOn Monday, 2 December 2019, a TGA Progress Report to the Senate Mesh Inquiry was tabled in the Senate