Footnotes
Chapter 1 - The role of the Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prothese (PIP) breast implants
[1] Jordanna
Schriever, 540 women register for class action against breast implant maker,
23 March 2012, The Advertiser, http://www.adelaidenow.com.au/ipad/women-register-for-class-action-against-breast-implant-maker/story-fn6bqphm-1226302149137
(viewed 13 April 2012).
Chapter 2 - Overview of the PIP breast implants situation
[1] Department of Health and
Ageing, Consumers Questions and Answers: PIP breast implants,
updated 27 April 2012, p. 1, http://www.health.gov.au/internet/main/publishing.nsf/content/2DB01EA9F428C399CA2579F1001F3DE9/$File/Q&A-TGA-Factsheet-2012.pdf
(accessed 11 May 2012).
[2] Reuters, No
need for routine removal of breast implants: UK, 6 January 2012, http://www.reuters.com/article/2012/01/06/us-implants-britain-idUSTRE8051EU20120106
(accessed 16 April 2012).
[3]
Therapeutic Goods Administration, Australian Regulatory Guidelines
for Medical Devices, May 2011, p. 20, http://www.tga.gov.au/pdf/devices-argmd.pdf
(accessed 21 May 2012).
[4]
Consumers Questions and Answers: PIP Implants, Therapeutic Goods
Administration website 12 January 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120107.htm
(accessed 16 April 2012).
[5]
Department of Health and Ageing, Submission 30, p. 5.
[6]
Therapeutic Goods Administration, Australian Regulatory Guidelines
for Medical Devices, May 2011, p. 26, http://www.tga.gov.au/pdf/devices-argmd.pdf
(accessed 21 May 2012).
[7]
Therapeutic Goods Administration, PIP breast implants – a summary,
PIP breast implants – An Australian Perspective, 23 March 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120323.htm#summary
(accessed 13 April 2012).
[8]
Department of Health and Ageing, Submission 30, p. 9.
[9]
Therapeutic Goods Administration, Special Access Scheme, 9 June
2011, p. 1, http://www.tga.gov.au/hp/access-sas.htm#about
(accessed 20 May 2012).
[10]
Department of Health and Ageing, Submission 30, Footnote 2 p. 8.
[11]
Name withheld, Submission 37, p. 2.
[12]
Therapeutic Goods Administration, Access to unapproved therapeutic
goods via Special Access scheme, 16 November 2009, p. 9, http://www.tga.gov.au/hp/access-sas-guidelines.htm
(accessed 21 May 2012).
[13]
Name withheld, Submission 37, p. 2.
[14]
Senate Community Affairs References Committee, The regulatory standards
of medical devices in Australia, November 2011, p. 4.
[15]
Dr Brian Richards, Therapeutic Goods Administration, Committee Hansard,
9 May 2012, p. 29.
[16]
Department of Health and Ageing, Submission 30, p. 5.
[17]
Senate Community Affairs References Committee, The regulatory standards
of medical devices in Australia, November 2011, p. 4.
[18]
Therapeutic Goods Administration, PIP breast implants – TGA update,
2 April 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120402.htm
(accessed 15 May 2012).
[19]
Department of Health and Ageing, Submission 30, p. 16.
[20]
Department of Health and Ageing, Submission 30, p. 12.
[21]
Therapeutic Goods Administration, Australian Regulatory Guidelines for
Medical Devices, Section 22, post-market vigilance and
monitoring requirements, May 2011, p. 294.
[22]
Therapeutic Goods Administration, Australian Regulatory Guidelines for
Medical Devices, Section 22, post-market vigilance and monitoring
requirements, May 2011, p. 294.
[23]
Department of Health and Ageing, Submission 30, p. 17.
[24]
Therapeutic Goods Administration, Australian Regulatory Guidelines for
Medical Devices, Section 22, post-market vigilance and monitoring
requirements, May 2011, p. 298.
[25]
Department of Health and Ageing, Submission 30, p. 28.
[26]
Therapeutic Goods Administration, response to written question on notice,
25 May 2012 (received 28 May 2012).
[27]
Therapeutic Goods Administration, Australian Regulatory Guidelines for
Medical Devices, Section 22, post-market vigilance and monitoring
requirements, May 2011, p. 301.
[28]
Medical Technology Association of Australia, Submission 15, p. 6.
[29]
Medical Technology Association of Australia, Submission 15, p. 7.
[30]
Therapeutic Goods Administration, Users Medical Device Incident Report
form, March 2012, http://reporting.tga.gov.au/mdir/udir03.aspx
(accessed 22 May 2012).
[31]
Name withheld, Submission 36, p. 3.
[32]
Name withheld, Submission 35, p. 2.
[33]
Department of Health and Ageing, Submission 30, p. 20.
[34]
Department of Health and Ageing, Submission 30, p. 48.
[35]
Department of Health and Ageing, Submission 30, p. 27.
[36]
Therapeutic Goods Administration, Poly Implant Prothese (PIP) breast
implants – the Australian Perspective, 4 January 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-120104.htm
(accessed 28 May 2012).
[37]
Therapeutic Goods Administration, PIP breast implants – TGA update,
25 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120525.htm
(accessed 28 May 2012).
[38]
Refer to the Senate Community Affairs References Committee report, The
regulatory standards of medical devices in Australia, 22 November 2011 for
detailed information on Conformity Assessment Certificate arrangements.
[39]
Department of Health and Ageing, Submission 30, p. 15.
[40]
Department of Health and Ageing, Submission 30, pp. 23-24.
[41]
Department of Health and Ageing, Submission 30, p. 24.
[42]
Department of Health and Ageing, Submission 30, p. 48.
[43]
Department of Health and Ageing, Submission 30, p. 48.
[44]
Department of Health and Ageing, Submission 30, p. 25.
[45]
Department of Health and Ageing, Submission 30, p. 26.
[46]
Department of Health and Ageing, Submission 30, p. 26.
[47]
Therapeutic Goods Administration, Advisory Committee on Medical Devices,
http://www.tga.gov.au/about/committees-acmd.htm
(accessed 30 May 2012)
[48]
Department of Health and Ageing, Submission 30, p. 26.
[49]
Department of Health and Ageing, Submission 30, p. 12.
[50]
Senate Community Affairs References Committee, The regulatory standards
of medical devices in Australia, November 2011, pp. 7-8.
[51]
Australian Government, TGA Reforms: A blueprint for TGA's future,
December 2011, p. 11, http://www.tga.gov.au/newsroom/media-2011-tga-reforms-111208.htm
(accessed 22 May 2012).
[52]
Agence française de sécurité sanitaire des produits de
santé (now known as National Security Agency of Medicines and Health
Products or ANSM).
[53]
Department of Health and Ageing, Submission 30, Attachment 1, p.
49.
[54]
Therapeutic Goods Administration, PIP Breast Implants – TGA Update,
5 April 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120405.htm
(accessed 13 April 2012).
[55]
Department of Health and Ageing, Submission 30, p. 8.
[56]
National Health Service, United Kingdom, PIP breast implants – latest
from the NHS, 15 May 2012, http://www.nhs.uk/news/2012/01January/Pages/government-review-advises-on-french-pip-breast-implants.aspx
(accessed 17 May 2012).
[57]
No Routine Removal of PIP breast implants, 6 January 2012, http://news.sky.com/home/uk-news/article/16143989
(accessed 15 May 2012)
[58]
Department of Health and Ageing, Submission 30, p. 5.
[59]
UK Medicines and Healthcare products Regulatory Agency press release, PIP
breast implants UK medical devices regulator says no evidence to support
routine removal, 23 December 2011, http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON137935
(accessed 17 May 2012).
[60]
House of Commons Health Committee, PIP Breast implants and regulation of
cosmetic interventions, Sixteenth Report of Session 2010-12, 21 March 2012,
p. 8.
[61]
Dame Sally Davies, United Kingdom Chief Medical Officer, Letter to
medical practitioners regarding PIP implants update, 15 March 2012, p. 2, http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_133075.pdf
(accessed 21 May 2012).
[62]
Scientific Committee on Emerging and Newly Identified Health Risks, The
Safety of PIP Silicone Breast Implants, 1 February 2012, http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_034.pdf
(accessed 14 May 2012).
[63]
House of Commons Health Committee, PIP Breast implants and regulation
of cosmetic interventions, Sixteenth Report of Session 2010-12, 21 March
2012, p. 3.
[64]
Dame Sally Davies, United Kingdom Chief Medical Officer, Letter to medical
practitioners regarding PIP implants update, 15 March 2012, pp. 1-2, http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_133075.pdf
(accessed 21 May 2012).
[65]
Dame Sally Davies, United Kingdom Chief Medical Officer, Letter to
medical practitioners regarding PIP implants update, 15 March 2012, p. 2, http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_133075.pdf
(accessed 21 May 2012).
[66]
Dr Daniel Fleming, Australasian College of Cosmetic Surgery, Committee
Hansard , 9 May 2012, p.23
Chapter 3 - Recall of PIP breast implants – TGA monitoring and withdrawal of medical devices
[1]
Department of Health and Ageing, Submission 30, p. 29.
[2] Agence
Française de Securité Sanitaire des Produits de Santé (AFSSAPS), now known
as National Security Agency of Medicines and Health Products (ANSM).
[3]
Department of Health and Ageing, Submission 30, p. 28.
[4]
Department of Health and Ageing, Submission 30, p. 29.
[5] Therapeutic
Goods Administration, Silicone gel breast implants manufactured by Poly
Implant Prothese of France, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-100406.htm
(accessed 22 May 2012).
[6] Department
of Health and Ageing, Submission 30, p. 29.
[7]
Department of Health and Ageing, Submission 30, p. 1.
[8] Department
of Health and Ageing, Submission 30, p. 30.
[9] Name
withheld, Submission 23, p. 3.
[10] Dr
Brian Richards, Therapeutic Goods Administration, Committee Hansard, 9
May 2012, p. 35.
[11] Therapeutic
Goods Administration, Poly Implant Prothese (PIP) breast implants, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip.htm
(accessed 22 May 2012).
[12] Therapeutic
Goods Administration, Poly Implant Prothese (PIP) breast implants, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip.htm
(accessed 22 May 2012).
[13]
Dr Brian Richards, Therapeutic Goods Administration, Committee Hansard,
9 May 2012, p. 33.
[14]
Press release of French Minister for Labour, employment and Health, 23
December 2011, http://www.ansm.sante.fr/var/ansm_site/storage/original/application/41d18730821fc09793fc9b848f6e090b.pdf
(accessed 25 May 2012).
[15] Department
of Health and Ageing, Poly Implant Prothese Breast Implants, Report of the
Chief Medical Officer, April 2012, p.5.
[16] Consumers
Health Forum Australia, Submission 17, p. 4.
[17] Consumers
Health Forum Australia, Submission 17, p. 4.
[18] Consumers
Health Forum Australia, Submission 17, p. 4.
[19] Ms
Karen Carey, Consumers Health Forum Australia, Committee Hansard, 9 May
2012, p. 4.
[20] Department
of Health and Ageing, Submission 30, p. 36.
[21] Therapeutic
Goods Administration, PIP breast implants – An updated Australian
Perspective, 23 March 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120323.htm
(accessed 22 May 2012).
[22] Department
of Health and Ageing, Submission 30, p. 34.
[23] Department
of Health and Ageing, Submission 30, p. 35.
[24] Dr
Brian Richards, Therapeutic Goods Administration, Department of Health and
Ageing, Committee Hansard, 9 May 2012, p. 36.
[25] Therapeutic
Goods Administration, PIP breast implants – An updated Australian
Perspective, 23 March 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120323.htm
(accessed 22 May 2012).
[26] Department
of Health and Ageing, Poly Implant Prothese Breast Implants, Report of the
Chief Medical Officer, April 2012, p.8.
[27] Name
withheld, Submission 48, p. 2.
[28] Dr
Daniel Fleming, Response to Adverse comments made in submissions Nos 7, 46,
47 and 48, received 8 May 2012, pp. 4-5.
[29] Ms
Karen Carey, Consumers Health Forum Australia, Committee Hansard, 9 May
2012, p. 3.
[30] Department
of Health and Ageing, Submission 30, p. 30.
[31] Department
of Health and Ageing, Submission 30, p. 30.
[32] Therapeutic
Goods Administration, Silicone breast implants manufactured by Poly Implants
Prothese (PIP) of France – an update, 2 July 2010, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-100702.htm
(accessed 22 May 2012).
[33] Department
of Health and Ageing, Submission 30, p. 32.
[34] Name
withheld, Submission 7, p. 3.
[35] Ms
Suellen Telford, Submission 39, p. 1.
[36] Dr
Brian Richards, Therapeutic Goods Administration, Department of Health and
Ageing, Committee Hansard, 9 May 2012, p. 33.
[37] Department
of Health and Ageing, Submission 30, p. 30.
[38] Department
of Health and Ageing, Poly Implant Prothese Breast Implants, Report of the
Chief Medical Officer, April 2012, p. 11.
[39] Mr
Tim White, Tindall Gask Bentley, answers to questions on notice, 9 May 2012
(received 17 May 2012).
[40] Therapeutic
Goods Administration, PIP breast implants – An updated Australian
Perspective, 23 March 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120323.htm
(accessed 22 May 2012).
[41] Ms
Karen Carey, Consumers Health Forum Australia, Committee Hansard, 9 May
2012, p. 2.
[42] Associate
Professor Rodney Cooter, Australian Society of Plastic Surgeons, Committee
Hansard, 9 May 2012, p. 9.
[43] Associate
Professor Rodney Cooter, Australian Society of Plastic Surgeons, Committee
Hansard, 9 May 2012, p. 9.
[44] Therapeutic
Goods Administration, Australian Regulatory Guidelines for Medical Devices,
Section 22, Post-market vigilance and monitoring requirements, May 2011, p.
304.
[45] Therapeutic
Goods Administration, PIP breast implants – TGA update, 18 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120518.htm
(accessed 22 May 2012).
[46] Therapeutic
Goods Administration, PIP breast implants – TGA update, 18 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120518.htm
(accessed 22 May 2012).
[47] Therapeutic
Goods Administration, Poly Implant Prothese breast implants – An Australian
Perspective, 4 January 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-120104.htm
(accessed 23 May 2012)
[48] Australasian
College of Cosmetic Surgery, Submission 24, p. 5.
[49] Name
withheld, Submission 36, p. 3.
[50] Department
of Health and Ageing, Submission 30, p. 31 footnote 26.
[51] Senate
Community Affairs References Committee, Inquiry into The regulatory standards
for the approval of medical devices in Australia, Committee Hansard,27
September 2011, p. 18-19.
[52] Name
withheld, Submission 36, p. 3.
[53] Australian
Medical Association, Submission 2, pp. 1-2.
[54] Australian
Society of Plastic Surgeons, Submission 18, p. 5.
[55] Australian
Society of Plastic Surgeons, Submission 18, p. 2.
[56] Australian
Society of Plastic Surgeons, Submission 18, p. 2.
[57]
Name withheld, Submission 23, pp. 3-4.
[58]
Professor Chris Baggoley, Chief Medical Officer, Department of Health and
Ageing, Committee Hansard, 9 May 2012, p. 36.
[59] Australian
Medical Association, Submission 2, p. 1.
[60] Ms
Karen Carey, Consumers Health Forum Australia, Committee Hansard, 9 May
2012, p. 5.
[61] Department
of Health and Ageing, response to a question taken on notice, 9 May 2012,
received 23 May 2012.
[62] Department
of Health and Ageing, Submission 30, p. 39.
[63] Senate
Community Affairs References Committee, The regulatory standards of medical
devices in Australia, November 2011, p. 35.
[64] Australian
Society of Plastic Surgeons, Submission 18, p. 5.
[65] Monash
University, School of Public Health and Preventative Medicine, Submission 42,
pp. 1-2.
[66] Australian
Society of Plastic Surgeons, Submission 18, p. 6.
[67] Australian
Society of Plastic Surgeons, Submission 18, p. 6.
[68] Department
of Health and Ageing, Submission 30, p. 6 and pp. 45-46.
[69] Dr
Richard Bartlett, First Assistant Secretary, Medical Benefits Division,
Department of Health and Ageing, Committee Hansard, 9 May 2012, p. 36.
[70] Department
of Health and Ageing, Medicare-Eligible MRI service for Poly Implant Protheses
(PIP) breast implants, 5 May 2012, http://www.health.gov.au/internet/main/publishing.nsf/Content/di-mri-pip,
(accessed 22 May 2012).
[71] Department
of Health and Ageing, Submission 30, p. 46.
[72] Australasian
College of Cosmetic Surgery, Submission 24, p. 2.
[73] Australasian
College of Cosmetic Surgery, Submission 24, p. 3.
[74] Associate
Professor Rodney Cooter, Australian Society of Plastic Surgeons, Committee
Hansard, 9 May 2012, p. 10.
[75] Department
of Health and Ageing, Submission 30, p. 6.
[76] Department
of Health and Ageing, Submission 30, p. 2.
[77] Department
of Health and Ageing, Submission 30, p. 6.
[78] Name
withheld, Submission 7, p. 2; Name withheld, Submission 16, p. 2.
[79] Name
withheld, Submission 35, p. 2; Name withheld, Submission 36, p.
4.
[80] Ms
Jane Halton PSM, Secretary of Department of Health and Ageing, Committee
Hansard, 9 May 2012, p. 38.
[81] Consumers
Health Forum Australia, Submission 17, p. 7.
[82] Consumers
Health Forum Australia, Submission 17, pp. 7-8.
Chapter 4 - Personal impact of PIP breast implants on Australian patients
[1]
Name withheld, Submission 32, p. 1.
[2] Name
withheld, Submission 47, p. 1.
[3] Name
withheld, Submission 35, p. 1.
[4] Ms
Nikki Janeway, Submission 19, p. 1.
[5]
Name withheld, Submission 26, p. 1.
[6] Mr
Tim White, Tindall Gask Bentley, Committee Hansard, 9 May 2012, p. 16.
[7] Dr
Brian Richards, Therapeutic Goods Administration, Department of Health and
Ageing, Committee Hansard, 9 May 2012, p. 29.
[8] Dr
Brian Richards, Therapeutic Goods Administration, Department of Health and
Ageing Committee Hansard, 9 May 2012, p. 34.
[9] Ms
Jodie Blake, Submission 33, p.1.
[10]
Name withheld, Submission 32, p. 2.
[11] Name
withheld, Submission 31, p. 1.
[12]
Name withheld, Submission 36, p. 2.
[13]
Name withheld, Submission 13, p. 1; Name withheld, Submission 32,
p.2; and Name withheld, Submission 35, p. 2.
[14]
Name withheld, Submission 25, p. 1; Name withheld, Submission 36,
p. 1; and Name withheld, Submission 18, p. 1.
[15] Ms
Suellen Telford, Submission 34, p. 1; and Name withheld, Submission
33, p. 2.
[16] Ms
Nikki Janeway, Submission 19, p. 2; Name withheld, Submission 12,
p. 1; Name withheld, Submission 27, p. 2; and Name withheld, Submission
36, p. 2.
[17]
Name withheld, Submission 36, p. 2; and Name withheld, Submission
35, p. 1.
[18]
Department of Health and Ageing, Poly Implant Prothese Breast Implants:
Report of the Chief Medical Officer, April 2012, p. 17.
[19] Name
withheld, Submission 32, p. 2.
[20] Name
withheld, Submission 26, p. 2.
[21] Name
withheld, Submission 13, p. 1.
[22]
Dr Daniel Fleming, Committee Hansard, 9 May 2012, p. 27.
[23]
The Breastfeeding Network (UK), Silicone Breast Implants and Breastfeeding,
http://www.breastfeedingnetwork.org.uk/pdfs/dibm/Silcone_Implants_and_Breastfeeding_January_2012.pdf
(accessed 18 May 2012).
[24]
Therapeutic Goods Administration, Consumers Questions and Answers,
27 April 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120107.htm
(accessed 18 May 2012).
[25]
Department of Health and Ageing, answer to question taken on notice, 9 May
2012, received 23 May 2012.
[26] Therapeutic
Goods Administration, PIP breast implants – TGA update, 18 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120518.htm
(accessed 20 May 2012);
[27] Channel
Nine Sixty Minutes, Toxic Time Bombs, 11 March 2012, http://sixtyminutes.ninemsn.com.au/article.aspx?id=8431882
(accessed 8 May 2012); Channel Seven, Sunday Night, Exploding PIP breast
implants, 11 March 2012, http://au.news.yahoo.com/sunday-night/transcripts/article/-/13143657/exploding-pip-breast-implants/
(accessed 8 May 2012).
[28]
Ms Suellen Telford, Submission 39, p. 1.
[29] Professor
Rodney Cooter, Australian Society of Plastic Surgeons, Committee Hansard,
9 May 2012, p. 11.
[30] Name
withheld, Submission 35, p. 3.
[31] Name
withheld, Submission 16, p. 2.
[32] Name
withheld, Submission 23, p. 3.
[33]
Name withheld, Submission 48, p. 1.
[34]
Name withheld, Submission 34, p. 1.
[35] Ms
Karen Carey, Consumers Health Forum, Committee Hansard, 9 May 2012, p.
4.
[36] Ms
Jane Halton, Secretary, Department of Health and Ageing, Committee Hansard,
9 May 2012, p. 34.
[37]
Australasian College of Cosmetic Surgeons, Submission 24, p. 5.
[38] Australasian
College of Cosmetic Surgeons, Submission 24, p. 5.
[39] Dr
Daniel Fleming, Australasian College of Cosmetic Surgeons, Committee Hansard,
9 May 2012, p. 24.
[40] Consumers
Health Forum Australia, Submission 17, p. 3.
[41] Australasian
College of Cosmetic Surgery, Submission 24, p. 1.
[42] Consumers
Health Forum Australia, Submission 17, p. 5.
[43] Name
withheld, Submission 34, p. 1.
[44] Example
of TGA alert, PIP breast implants – TGA Update, 18 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120518.htm
(accessed 20 May 2012).
[45] Dr
Brian Richards, Therapeutic Goods Administration, Committee Hansard, 9
May 2012, p. 35.
[46] Dr
Brian Richards, Therapeutic Goods Administration, Committee Hansard, 9
May 2012, p. 35.
[47] Dr
Brian Richards, Therapeutic Goods Administration, Committee Hansard, 9
May 2012, p. 35.
[48] Ms
Jodie Blake, Submission 33, p. 1.
[49] Name
withheld, Submission 35, pp. 1-2;
[50] Name
withheld, Submission 7, p. 2.
[51] Name
withheld, Submission 35, p. 1.
[52] Name
withheld, Submission 23, p.3.
[53]
Dr Daniel Fleming, Australasian College of Cosmetic Surgery, Committee
Hansard, 9 May 2012, p. 25.
[54] Australian
Society of Plastic Surgeons, Code of Practice 2011, p. 10.
[55] Australian
Society of Plastic Surgeons, Code of Practice 2011, p. 13.
[56] Australasian
College of Cosmetic Surgery, ACCS Consumer/Patient Code of Practice, p.
4.
[57] Australasian
College of Cosmetic Surgery, ACCS Consumer/Patient Code of Practice, p.
14.
[58] Mr
Richard Bartlett, Department of Health and Ageing, Committee Hansard, 9
May 2012,
p. 37.
[59] Department
of Health and Ageing, List of Diagnostic Imaging Practices that Provide Breast MRI
services, http://www.health.gov.au/internet/main/publishing.nsf/Content/1FC8BB90FA205A1BCA2579C600081471/$File/Table%20of%20Eligible%20PIP%20MRI's%2027%20April%2012.pdf
(accessed 21 May 2012).
[60]
Department of Health and Ageing, answer to question taken on notice, 9 May
2012, received 23 May 2012.
Chapter 5 - Summary of key issues
[1]
Australian Medical Association, Submission 2, p. 1.
[2]
Therapeutic Goods Administration, PIP breast implants – TGA update,
25 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120525.htm
(accessed 28 May 2012).
[3]
Department of Health and Ageing, Submission 30, p. 31.
[4]
Therapeutic Goods Administration, PIP breast implants – TGA update,
25 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120525.htm
(accessed 28 May 2012).
[5]
Name withheld, Submission 36, p. 3.
[6]
Dr Brian Richards, Therapeutic Goods Administration, Committee
Hansard, 9 May 2012, pp. 30-31.
[7]
Dr Daniel Fleming, Australasian College of Cosmetic Surgery, Committee
Hansard, 9 May 2012, p. 24.
[8]
Therapeutic Goods Administration, PIP breast implants – TGA update,
25 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120525.htm
(accessed 28 May 2012).
[9]
Therapeutic Goods Administration, PIP breast implants – TGA update,
25 May 2012, http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120525.htm
(accessed 28 May 2012).
[10]
Dr Brian Richards, Therapeutic Goods Administration, Committee Hansard,
9 May 2012, p. 31.
[11]
Dr Daniel Fleming, Australasian College of Cosmetic Surgery, Committee
Hansard, 9 May 2012, p. 24.
[12]
Department of Health and Ageing, Submission 30, p. 32.
[13]
Department of Health and Ageing, Submission 30, p. 35.
[14]
Dr Daniel Fleming, Australasian College of Cosmetic Surgery, Committee
Hansard, 9 May 2012, p. 25.
Additional comments by Senator Xenophon - The human consequences of regulatory failure
[1]
Australian Securities and Investments Commission, ASIC Historical Company
Extracts, 24 January 2012 (attachment 1)
[2]
Professor Rodney Cooter, Australian Society of Plastic Surgeons, Committee
Hansard, 9 May 2012, p. 8
[3]
The Hon. Dr Michael Armitage, AHIA, Community Affairs References Committee
Hansard, 27 September 2011, p 4
[4]
Therapeutic Goods Administration website: http://www.tga.gov.au/archive/committees-mdec.htm,
retrieved 29 May 2012
[5]
Department of Health and Ageing, Submission 30, p. 25
[6]
Community Affairs References Committee, Report on the regulatory standards
for the approval of medical devices in Australia, p. 99
[7]
Ibid, p. 100
[8]
Dr Feming, Committee Hansard, 9 May 2012, p. 23
[9]
Background Briefing, 5 February 2012, online: http://www.abc.net.au/radionational/programs/backgroundbriefing/pip-implants/3804660#,
retrieved 31 May 2012
[10]
Ibid
[11]
Community Affairs References Committee, Report on the regulatory standards
for the approval of medical devices in Australia, p. 76
[12]
Therapeutic Goods Administration, answer to question on notice, Budget
Estimates June 2010, received 11 October 2010 (attachment 2)
[13]
Therapeutic Goods Administration, answer to question on notice, received 23 May
2012
[14]
Ms Karen Carey, Consumers Health Forum, Committee Hansard, 9 May 2012,
p. 4
[15]
Department of Health and Ageing, Submission, p.31 footnote 26
[16]
Prof. Rod Cooter, Australian Society of Plastic Surgeons, Committee Hansard,
9 May 2012, p. 7
[17]
Dr Daniel Fleming, Australasian College of Cosmetic Surgery, Committee
Hansard,, 9 May 2012, p. 21
[18]
Dr Brian Richards, Therapeutic Goods Administration, Committee Hansard,
9 May 2012, p. 30
[19]
Ms Karen Carey, Consumers Health Forum, Committee Hansard, 9 May 2012,
p. 3