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