Footnotes

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

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