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

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

31 May 2012

© Commonwealth of Australia 2012
ISBN 978-1-74229-645-6

View the report as a single document - (PDF 776KB)


View the report as separate downloadable parts:

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MEMBERSHIP OF THE COMMITTEE (PDF 27KB)
 
Recommendations (PDF 17KB)
 
Chapter 1 - The role of the Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prothese (PIP) breast implants (PDF 21KB)

Terms of Reference
Conduct of the current inquiry
Acknowledgements and notes
Previous inquiry regarding medical devices
Structure of the report

 
Chapter 2 - Overview of the PIP breast implants situation (PDF 100KB)

Introduction
Roles and responsibilities in monitoring medical devices

 
Chapter 3 - Recall of PIP breast implants – TGA monitoring and withdrawal of medical devices (PDF 119KB)

Actions undertaken for the Australian recall of PIP breast implants
Government action after the recall of PIP breast implants

 
Chapter 4 - Personal impact of PIP breast implants on Australian patients (PDF 84KB)

Key issues

 
Chapter 5 - Summary of key issues (PDF 33KB)

Conclusion

 
Additional comments by Government Senators (PDF 5KB)
 
Additional comments by Senator Xenophon - The human consequences of regulatory failure (PDF 295KB)

Senator Xenophon additional comments- attachments

 
Appendix 1 - Submissions received by the committee (PDF 6KB)
 
Appendix 2 - Public hearings (PDF 5KB)
 
Appendix 3 - Health and Ageing chronology of events (PDF 108KB)
 
Appendix 4 - List of Recommendations made in the report into The Regulatory Standards for the Approval of Medical Devices in Australia (PDF 11KB)

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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