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.
Latest alerts
- 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.
- Breast implants (all alerts)Breast implants (all alerts)
- Medtronic MiniMed 600 and 700 series Insulin PumpsMiniMed 600 and 700 series Insulin Pumps - Medtronic - Loss of power due to cracked or damaged battery cap.
Latest articles
- Acellular dermal matrix products used in breast reconstructionAcellur Dermal Matrix Products used in Breast Reconstruction - clarification on reports of potential higher complication rates.
- Limitations of pulse oximeters and the effect of skin pigmentationMedical device safety update regarding pulse oximeters limitations, including the effect of skin pigmentation.
- Patient implant cards and information leafletsAn overview of the information that will be provided in patient information leaflets and patient implant cards for permanently implantable medical devices
Latest publications
- Progress update: Improving post-market monitoring and surveillance of medical devicesIn 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