Terms of Reference

The role of the Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prothese (PIP) breast implants

Terms of Reference

The role of the Government and the Therapeutic Goods Administration (TGA) regarding the approval and monitoring of medical devices listed on the Australian Register of Therapeutic Goods, including:
        (a) the TGA's approval, monitoring, withdrawal and follow-up of the Poly Implant Prothese (PIP) breast implants;  
        (b) the procedures the TGA has in place to continuously monitor relevant information in relation to device manufacturers and sponsors, including the legal or approval issues both in          Australia and overseas;  
        (c) information provided to the Government in relation to the PIP breast implants;  
        (d) the impact of PIP breast implant failures on Australian patients;  
        (e) the procedures the TGA has in place to assess the risk to Australian patients if devices available in Australia are the subject of warnings or withdrawals overseas;  
        (f) the procedures the TGA has in place to communicate device information (including withdrawal information) to the general public, with a focus on affected patients; and  
        (g) the ability of the TGA to undertake or commission research in relation to specific areas of concern regarding devices, such as metal-on-metal implants.

(2) That, in conducting its inquiry, the committee should consider:  
        (a) the report and findings of the 2011 Community Affairs References Committee inquiry into medical devices; and  
        (b) any action the Government and TGA has taken or intends to take in relation to the 2011 report and recommendations.
For further information, contact:

Committee Secretary
Senate Standing Committees on Community Affairs
PO Box 6100
Parliament House
Canberra ACT 2600
Australia

Phone:+61 2 6277 3515
Fax:+61 2 6277 5829
Email:community.affairs.sen@aph.gov.au

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