[1]        Associate Professor Christopher Maher, Explaining the vaginal mesh controversy, The University of Queensland, Faculty of Medicine, https://medicine.uq.edu.au/article/2017/06/explaining-vaginal-mesh-controversy (accessed 20 June 2017).

[2]        Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Submission 36, p. 2; Department of Health (Department), Submission 19, p. 26.

[3]        Associate Professor Christopher Maher Submission 154, p. [1].

[4]        Submission 154, p. [5].

[5]        Submission 154, p. [5].

[6]        Department, Submission 19, p. 15.

[7]        Urogynaecology Units at the Mercy Hospital for Women and Monash Health, Submission 44, p. 3.

[8]        Department, Therapeutic Goods Administration, Urogynaecological surgical mesh complications, https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications (accessed 5 January 2018).

[9]        Shine Lawyers, 'Manufacturers face multiple actions for faulty implants worldwide',  https://www.shine.com.au/service/class-actions/johnson-johnson-ethicon-class-action/manufacturers-face-multiple-actions-for-faulty-implant/ (accessed 21 July 2017); Hannah Devlin, The Guardian, 'Senior doctors call for public inquiry into use of vaginal mesh surgery in UK', 19 July 2017, https://www.theguardian.com/society/2017/jul/18/senior-doctors-call-for-public-inquiry-into-use-of-vaginal-mesh-surgery-in-uk (accessed 21 July 2017); CTV News, 'Canadian women reach transvaginal mesh settlement', 2 April 2016, https://www.ctvnews.ca/canada/canadian-women-reach-transvaginal-mesh-settlement-1.2842781 (accessed 21 July 2017).

[10]      Accident Compensation Corporation (ACC), ACC Surgical Mesh Review, Analysis of Treatment Injury Claims 1 July 2005 to 30 June 2014, 13 March 2015; ACC, ACC treatment injury claims: Surgical mesh-related claim data from 1 July 2005 to 30 June 2017, 18 October 2017.

[11]      Scottish Government, Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Interim Report, 2 October 2015; Scottish Government, Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Final Report, 27 March 2017.

[12]      NHS England, Mesh Working Group, Interim Report, December 2015; NHS England, Mesh Oversight Group Report, 25 July 2017.

[13]      Department, Submission 19, p. 20.

[14]      The PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials (PROSPECT) comprised two large randomised trials in 35 hospitals in the United Kingdom. It compared various types of mesh devices to native tissue repair for pelvic organ prolapse in women having their first surgical repair for pelvic organ prolapse. Submission 19, p. 20.

[15]      The terms of reference for the inquiry are available at Appendix 1 and on the committee's website: https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Terms_of_Reference.

[16]      The Senate referred the matter to the committee on 15 February 2017 for inquiry and report by 30 November 2017. On 16 November 2017, the Senate granted an extension of time for reporting until 14 February 2018, on 14 February 2018 the Senate granted an extension until 20 March 2018 and on 20 March 2018 the Senate granted a further extension until 27 March 2018. See Journals of the Senate: https://www.aph.gov.au/Parliamentary_Business/Chamber_documents/Senate_chamber_documents/Journals_of_the_Senate.

[17]      The committee held the following public hearings: 3 August 2017 in Melbourne, 25 August 2017 in Perth, 18 September 2017 in Sydney, 19 September 2017 in Canberra and 6 February 2017 in Canberra. The list of witnesses who provided evidence at the public hearings is available at Appendix 2.

[18]      A list of submissions received by the committee is available at Appendix 3 and on the committee's website: https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Submissions.

[19]      Shine Lawyers, Johnson & Johnson/Ethicon Class Action, https://www.shine.com.au/service/class-actions/johnson-johnson-ethicon-class-action/.

[20]      Shine Lawyers, American Medical Systems Mesh Class Action, https://www.shine.com.au/service/class-actions/american-medical-systems-mesh-class-action/.

[21]      Submission 45, p. 4.

[22]      Dr Michelle Atherton, Submission 98, p.1.

[23]      Victoria State Government, Better Health Channel, Transvaginal mesh, https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/Transvaginal-mesh (accessed 31 January 2018).

[24]      RANZCOG, Submission 36, p. 2.

[25]      Department, Submission 19, p. 11.

[26]      Monash Health, Submission 44, p. 1; RANZCOG, Submission 36, p. 1.

[27]      RANZCOG, Submission 36, p. 1; RANZCOG Communique, Use of mesh for the surgical treatment of vaginal prolapse and urinary incontinence, updated 29 October 2017: https://www.ranzcog.edu.au/news/Use-of-mesh-for-the-surgical-treatment-of-vaginal (accessed 17 January 2017).

[28]      Urogynaecological Society of Australasia (UGSA), Information Sheet, Stress Urinary Incontinence, Submission 32, Attachment 1, p. 2.

[29]      Continence Foundation of Australia, Submission 35, p. [1].

[30]      UGSA and RANZCOG, Position statement on midurethral slings, Submission 32, Attachment 7, p. 2.

[31]      See, for example: Name withheld, Submission 56, p. 5; Dr Darren Gold, Submission 145, Attachment 1, p. 1, Name withheld, Submission 418, p. 8; Name withheld, Submission 463, p. 1; Name withheld, Submission 519, p. 5.

[32]      International Urogynaecological Association, Stress Urinary Incontinence, A Guide for Women, Submission 32, Attachment 8, p. [2].

[33]      UGSA, Information Sheet, Mid-urethral Slings, Submission 32, Attachment 3, p. [1].

[34]      UGSA, Submission 32, Attachment 3.

[35]      RANZCOG Communique, Use of mesh for the surgical treatment of vaginal prolapse and urinary incontinence, updated 29 October 2017.

[36]      UGSA Information Sheet, Mid-urethral Slings, Submission 32, Attachment 3, p. [1].

[37]      UGSA, Submission 32, p. 1; Dr Darren Gold, Submission 145, p. [3].

[38]      RANZCOG, Submission 42, p. 2.

[39]      Submission 36, p. 2.

[40]      Submission 36, p. 2.

[41]      Adjunct Professor John Skerritt, Deputy Secretary, Department of Health, Submission 19, p. 3.

[42]      Committee Hansard, 3 August 2017, p. 50.

[43]      Therapeutic Goods Administration, Consultation: Alignment with European medical device regulatory framework, 28 July 2017, https://www.tga.gov.au/consultation/consultation-alignment-european-medical-device-regulatory-framework (accessed 16 March 2018).

[44]      Department, Submission 19, p. 4.

[45]      Submission 19, pp. 5-6.

[46]      RANZCOG, Committee Hansard, p. 19, Urogynaecological Society of Australia, Committee Hansard, 18 September 2017, p. 14.

[47]      Professor Stephen Robson, President, RANZCOG, Committee Hansard, 19 September 2017, p. 19.

[48]      Australian Commission on Safety and Quality in Health Care, Governance, https://www.safetyandquality.gov.au/about-us/governance/ (accessed 8 October 2017).

[49]      Adjunct Professor Debora Picone, Chief Executive Officer, Australian Commission on Safety and Quality in Health Care, Committee Hansard, 3 August 2017, p. 39.

[50]      Prof Picone, Committee Hansard, 3 August 2017, p. 39.

[51]      Prof Picone, Committee Hansard, 3 August 2017, p. 39.

[52]      Additional Information, Australian Commission on Safety and Quality in Health Care update, received 6 February 2018, p. 1.

Chapter 2 - The impact of transvaginal mesh procedures

[1]        Name withheld, Submission 110, p. 1.

[2]        See, for example: Johnson & Johnson Medical, Submission 23, p. 10; Urogynaecological Society of Australasia (UGSA), Submission 32, p. 2; Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Submission 36, p. 9.

[3]        See, for example: UGSA, Submission 32, p. 3; Continence Foundation of Australia, Submission 35, p. 2; RANZCOG, Submission 36, p. 7; Urological Society of Australia and New Zealand (USANZ), Submission 42, p. 3.

[4]        Health Issues Centre (HIC), Submission 115, p. 3.

[5]        RANZCOG, Submission 36, p. 9.

[6]        Committee Hansard, 25 August 2017, p. 3.

[7]        Department of Health, Therapeutic Goods Administration, Urogynaecological surgical mesh complications, https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications (accessed 5 January 2018).

[8]        Ms Stella Channing, Director and Administrator, Australian Pelvic Mesh Support Group (APMSG), Committee Hansard, 25 August 2017, p. 3.

[9]        Royal Women's Hospital (RWH), Submission 34, p. 5.

[10]      Confidential Submission 465.

[11]      See, for example: Name withheld, Submission 102; Name withheld, Submission 106; Name withheld, Submission 133; Name withheld, Submission 141, Name withheld, Submission 289.

[12]      See, for example: Name withheld, Submission 2; Name withheld, Submission 4; Name withheld, Submission 103; Name withheld, Submission 141; Name withheld, Submission 258; Name withheld, Submission 356; Name withheld, Submission 461.

[13]      Submission 154, p. [14].

[14]      Women's Health and Research Institute of Australia (WHRIA), Submission 39, p. 1.

[15]      Committee Hansard, 25 August 2017, p. 3.

[16]      Name withheld, Submission 403, p. 1.

[17]      Name withheld, Submission 374, p. 5.

[18]      Gai, Committee Hansard, 18 September 2017, p. 5.

[19]      Melinda, Committee Hansard, 3 August 2017, p. 13.

[20]      Andrea, Committee Hansard, 3 August 2017, p. 2.

[21]      Name withheld, Submission 102, p. 4.

[22]      Committee Hansard, 18 September 2017, p. 7.

[23]      Committee Hansard, 18 September 2017, p. 1.

[24]      See, for example: Name withheld, Submission 58, p. 3; Name withheld, Submission 175, p. 5; Name withheld, Submission 176, p. [1]; Name withheld, Submission 179, p. [1]; Name withheld, Submission 390, p. [1].

[25]      Department of Health, Submission 19, p. 19; UGSA, Submission 32, p. 3.

[26]      UGSA, Submission 32, p. 3; RWH, Submission 34, p. 5.

[27]      HIC, Submission 115, p. 9.

[28]      Monash Health, Submission 47, p. [3].

[29]      Department, Submission 19, p. 19.

[30]      Associate Professor Paul Duggan, Submission 63, p. [1].

[31]      UGSA, Submission 32, p. 3.

[32]      Associate Professor Christopher Maher, Submission 154, pp. [13-14].

[33]      Submission 154, pp. [13-14].

[34]      UGSA, Submission 32, p. 3; RWH, Submission 34, p. 5.

[35]      Committee Hansard, 18 September 2017, p. 16.

[36]      See, for example: Angela, Committee Hansard, 3 August 2017, p. 12; Angela, Committee Hansard, 25 August 2017, p. 19; Harriett, Committee Hansard, 19 September 2017, p. 3.

[37]      Fiona, Committee Hansard, 18 September 2018, p. 23.

[38]      Name withheld, Submission 102, p. [7].

[39]      Submission 154, pp. [12-13].

[40]      See, for example: Name withheld, Submission 109; Name withheld, Submission 113, p. 8; Name withheld, Submission 472, p. 1; Name withheld, Submission 477, p. [2].

[41]      Name withheld, Submission 462, p. 6.

[42]      Name withheld, Submission 109, p. [2].

[43]      See for example: Name withheld, Submission 102, p. [1]; Name withheld, Submission 113, p. [6]; Name withheld, Submission 148, p. 1, 5; Name withheld, Submission 258, p. [1]; Name withheld, Submission 289, p. [2]; Name withheld, Submission 390, p. [4-5].

[44]      Submission 47, p. [3].

[45]      Submission 154, p. [13].

[46]      See, for example: Melinda, Committee Hansard, 3 August 2017, p. 14; Melanie, Committee Hansard, 25 August 2017, p. 21; Name withheld, Submission 102, p. 9.

[47]      See, for example: Name withheld, Submission 4, p. 1; Name withheld, Submission 148, p. 5; Name withheld, Submission 429, p. 6; Name withheld, Submission 529.

[48]      Name withheld Submission 464, p. 2.

[49]      Name withheld, Submission 464, p. 2.

[50]      HIC, Submission 115, p. 9.

[51]      See, for example: Kim, Committee Hansard, 3 August 2017, p. 1; Robyn, Committee Hansard, 25 August 2017, p. 21; Harriett, Committee Hansard, 19 September 2017, p. 5; Name withheld, Submission 147.

[52]      See, for example: Name withheld, Submission 72; Name withheld, Submission 79, Attachment 1; Name withheld, Submission 114; Name withheld, Submission 392.

[53]      See, for example: Name withheld, Submission 87, p. [4]; Name withheld, Submission 420, p. [4].

[54]      Name withheld, Submission 458, p. [6].

[55]      See, for example: Name withheld, Submission 133; Name withheld, Submission 147; Name withheld, Submission 158; Name withheld, Submission 179; Name withheld, Submission 384.

[56]      Name withheld, Submission 113, p. 8.

[57]      See, for example: Name withheld, Submission 114, p. [5]; Name withheld, Submission 147, p. 6; Name withheld, Submission 385, p. [3]; Name withheld, Submission 521, p. [3].

[58]      Submission 42, p. 3.

[59]      Submission 98, p. [7].

[60]      Committee Hansard, 18 September 2017, p. 7.

[61]      See, for example: Name withheld, Submission 340; Name withheld, Submission 439; Name withheld, Submission 524.

[62]      Name withheld, Submission 101, p. 3.

[63]      See, for example: Name withheld, Submission 133; Name withheld, Submission 182; Name withheld, Submission 398.

[64]      Name withheld, Submission 289, p. 4.

[65]      Name withheld, Submission 67, p. 1.

[66]      Name withheld, Submission 102, p. [5].

[67]      See, for example: Name withheld, Submission 67.

[68]      Name withheld, Submission 459, p. 1.

[69]      See, for example: Name withheld, Submission 220, p. 4; Name withheld, Submission 411, p. 5.

[70]      See, for example: Joanne, Committee Hansard, 18 September 2017, p. 3.

[71]      Name withheld, Submission 521, p. [4].

[72]      Name withheld, Submission 92, p. 2.

[73]      Name withheld, Submission 56, p. 5.

[74]      See, for example: Joanne, Committee Hansard, 18 September 2017, p. 5.

[75]      Name withheld, Submission 68, p. [2].

[76]      Joanne, Committee Hansard, 18 September 2017, p. 5.

[77]      Name withheld, Submission 4.

[78]      See, for example: Joanne, Committee Hansard, 18 September 2017, p. 3; Gai, Committee Hansard, 18 September 2017, p. 3.

[79]      Ms Harriett Desmond, Submission 159.1, p. [2].

[80]      Name withheld, Submission 521, p. [3].

[81]      Name withheld, Submission 524, p. 1.

[82]      Name withheld, Submission 410, p. [2].

[83]      Name withheld, Submission 459, p. 6.

[84]      APMSG, Submission 130, p. 6.

[85]      See, for example: Name withheld, Submission 118, p. [5]; Name withheld, Submission 137; Name withheld, Submission 123, p. 2; Name withheld, Submission 149, p. 5.

[86]      Harriett, Committee Hansard, 19 September 2017, p. 3.

[87]      Name withheld, Submission 494, p. 4.

[88]      See, for example: Name withheld, Submission 82; Name withheld, Submission 105, p. [5]; Joanne, Committee Hansard, 3 August 2017, p. 11.

[89]      See, for example, Name withheld, Submission 110, p. [11].

[90]      Name withheld, Submission 374, p. 6.

[91]      Tracey, Committee Hansard, 25 August 2017, p. 23.

[92]      See, for example: Name withheld, Submission 62, p. [3]; Name withheld, Submission 110, p. [11]; Name withheld, Submission 117, p. 3; Name withheld, Submission 257, p. [1, 6]; Name withheld, Submission 345, p. [1, 5];Name withheld, Submission 395, p. [1]; Name withheld, Submission 398, p. [2]; Name withheld, Submission 400, p. [1].

[93]      Name withheld, Submission 110, p. [11].

[94]      See, for example: Name withheld, Submission 110; Name withheld, Submission 114.

[95]      Professor Thierry Vancaillie, Committee Hansard, 18 September 2017, p. 11.

[96]      Health Issues Centre, Submission 115, p. 9.

[97]      Ms Elizabeth Howard, Osteopath and Pain Management, Women’s Health and Research Institute of Australia, Committee Hansard, 18 September 2017, p. 11.

[98]      See, for example: Name withheld, Submission 101, p. 1; Submission 345, p. [5].

[99]      Kylie, Committee Hansard, 18 September 2017, p. 24.

[100]    Name withheld, Submission 401. See also: Name withheld, Submission 113; Name withheld, Submission 118; Name withheld, Submission 401; Name withheld, Submission 424; Name withheld, Submission 521.

[101]    See, for example: Name withheld, Submission 67, p. 4; Name withheld, Submission 97, p. [3]; Name withheld, Submission 396, p. [3].

[102]    Name withheld, Submission 110, p. [5].

[103]    Name withheld, Submission 551, p. [1].

[104]    Gai, Committee Hansard, 18 September 2017, p. 5.

[105]    Mrs Elaine Holmes, Scottish Mesh Survivors Group, Committee Hansard, 19 September 2017, p. 36.

[106]    UGSA, Submission 32, p. 5.

[107]    See, for example: Name withheld, Submission 176; Name withheld, Submission 229, Name withheld, Submission 231, Name withheld, Submission 235, Name withheld, Submission 236, Name withheld, Submission 237, Name withheld, Submission 296; Name withheld, Submission 473.

[108]    See, for example: Name withheld, Submission 300.

[109]    See, for example: Submission 32, Attachment 14.

[110]    Timnat, Committee Hansard, 18 September 2017, p. 25.

[111]    Name withheld, Submission 127, p. [3].

[112]    Name withheld, Submission 473, p. 1.

[113]    Submission 473, p. 1.

[114]    UGSA, Submission 32, Attachment 15.

[115]    See, for example: Dr Jenny King, Urogynaecological Society of Australasia, Photographs: prolapse, (tabled 18 September 2017).

[116]    See, for example: Dr Caroline Dowling, Urologist, USANZ, Committee Hansard, 3 August 2017, p. 22; Dr Gary Swift, President, National Association of Specialist Obstetricians and Gynaecologists, 3 August 2017, p. 22.

[117]    Committee Hansard, 18 September 2017, p. 57.

[118]    Ms Sunny Hutson, Submission 151.

[119]    See, for example: RWH, Submission 34, p. 6.

[120]    UGSA, Submission 32, p. 1.

[121]    Submission 32, p. 3.

[122]    Dr De Souza, Committee Hansard, 3 August 2017, p. 31.

[123]    Submission 32, p. 2.

[124]    USANZ, Submission 42, p. 3.

[125]    Submission 42, p. 3.

[126]    See, for example: Mr Danny Vadasz, Chief Executive Officer, Health Issues Centre, Committee Hansard, 3 August 2017, p. 19.

[127]    APMSG, Number of complications involving stress urinary incontinence vs pelvic organ prolapse mesh procedures within the group's membership, received, additional information received 5 February 2018.

[128]    Submission 145, p. 4.

[129]    International Society for Pelviperineology (ISP), Submission 48, pp. 1- 2.

[130]    Submission 48, p. 2.

[131]    Dr Swift, Committee Hansard, 3 August 2017, p. 27.

[132]    Committee Hansard, 3 August 2017, p. 28.

[133]    Professor John Skerritt, Deputy Secretary, Health Products Regulation Group, Department of Health, Committee Hansard, 8 August 2017, p. 46.

[134]    APMSG, Number of complications involving stress urinary incontinence vs pelvic organ prolapse mesh procedures within the group's membership, received, additional information received 5 February 2018.

Chapter 3 - The extent of usage of transvaginal mesh implants in Australia

[1]        Gai, Committee Hansard, 18 September 2017, p. 4.

[2]        Department of Health (Department), Submission 19, p. 13; Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Submission 36, p. 3.

[3]        Department, Submission 19, p. 15; RANZCOG, Submission 36, p. 5.

[4]        Department, Submission 19, pp. 13-14.

[5]        Submission 19, p. 14.

[6]        RANZCOG, Submission 36, p. 5.

[7]        For example, the Urogynaecological Society of Australasia (UGSA) maintains a voluntary pelvic floor database, Submission 32, p. 3; Committee Hansard, 3 August 2018, p. 37.

[8]        Submission 19, p. 13.

[9]        Submission 19, p. 14.

[10]      See Therapeutic Goods (Medical Devices) Regulations 2002, part 8, para 8.1.

[11]      Submission 19, pp. 14-15.

[12]      Submission 19, p. 15.

[13]      Submission 19, p. 15.

[14]      Submission 19, p. 15.

[15]      Submission 23, p. 12.

[16]      Submission 19, p. 13.

[17]      Dr Megan Keaney, Medical Advisor, Department of Health, Committee Hansard, 19 September 2017, p. 42.

[18]      Department, Submission 19, p. 14.

[19]      Dr Keaney, Department of Health, Committee Hansard, 19 September 2017, p. 42.

[20]      UGSA, Submission 32, p. 2.

[21]      Associate Professor Christopher Maher, Submission 154, p. [10].

[22]      Department of Health, The Prostheses List, http://www.health.gov.au/internet/main/publishing.nsf/content/health-privatehealth-prostheseslist.htm (accessed 18 January 2018).

[23]      Department, Submission 19, p. 14.

[24]      RANZCOG, Submission 36, p. 3.

[25]      Submission 36, p. 3.

[26]      Submission 36, p. 3.

[27]      RANZCOG, Submission 36, p. 5.

[28]      Department of Health, Therapeutic Goods Administration, Reporting adverse events, https://www.tga.gov.au/reporting-adverse-events (accessed 29 January 2018).

[29]      Department of Health, Therapeutic Goods Administration, Reporting adverse events, https://www.tga.gov.au/reporting-adverse-events (accessed 29 January 2018).

[30]      Submission 19, p. 15.

[31]      Department, Submission 19, p. 30.

[32]      Ms Adriana Plantona, First Assistant Secretary, Medical Devices and Product Quality, Department of Health, Committee Hansard, 6 February 2018, p. 4.

[33]      Mr Danny Vadasz, Chief Executive Officer, Health Issues Centre, Committee Hansard, 3 August 2017, p. 17.

[34]      Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation Group, Department of Health Committee Hansard, 6 February 2018, p. 1.

[35]      Committee Hansard, 6 February 2018, p. 4.

[36]      Department, Submission 19, p. 16.

[37]      Department of Health, Therapeutic Goods Administration, IRIS inSite, https://www.tga.gov.au/iris-insite, (accessed 29 January 2018).

[38]      See, for example: Name withheld, Submission 105, p. [7]; Name withheld, Submission 108, p. 7; Name withheld, Submission 110, p. [11]; Name withheld, Submission 472; p. [2].

[39]      Joanne, Committee Hansard, 18 September 2017, p. 6.

[40]      Name withheld, Submission 477, p. 3.

[41]      See, for example: Name withheld, Submission 102, p. [5]; Name withheld, Submission 110, p. [12]; Name withheld, Submission 472; pp. [2, 5].

[42]      Name withheld, Submission 524, p. [2].

[43]      Name withheld, Submission 67, p. 4.

[44]      Robyn, Committee Hansard, 25 August 2017, p. 21.

[45]      Ms Carolyn Chisolm, APMSG, Committee Hansard, 25 August 2017, pp. 9-10.

[46]      Ms Pip Brennan, Committee Hansard, 25 August 2017, p. 49.

[47]      Committee Hansard, 25 August 2017, pp. 31-32.

[48]      Professor Skerritt, Committee Hansard, 6 February 2018, p. 6.

[49]      See, for example: Mr Danny Vadasz, HIC, Committee Hansard, 3 August 2017, p. 21, Name withheld, Submission 103, p. [4]; Kim, Committee Hansard, 3 August 2017, p. 2.

[50]      Gai, Committee Hansard, 18 September 2017, p. 6.

[51]      Name withheld, Submission 458, p. [7].

[52]      Kathryn, Committee Hansard, 19 September 2017, p. 4.

[53]      Committee Hansard, 25 August 2017, p. 9.

[54]      Committee Hansard, 3 August 2017, p. 22.

[55]      Royal Australian College of General Practitioners (RACGP), answers to questions on notice, 19 September 2017 (received 16 October 2017).

[56]      Dr Magdalene Simonis, Expert Committee, Quality Care, RACGP , Committee Hansard, 19 September 2017, p. 13.

[57]      See, for example: Associate Professor Angela Dawson, Convenor of the Women's Health Special Interest Group, Public Health Association of Australia, Committee Hansard, 3 August 2017, p. 9; Ms Stella Channing, Director and Administrator, Australian Pelvic Mesh Support Group, Committee Hansard, 25 August 2017, p. 3.

[58]      See, for example: Professor Thierry Vancaillie, Committee Hansard, 18 September 2017, p. 10; Dr Jenny King, Committee Hansard, 18 September 2017, p. 16; Professor Jason Abbott, President, Australasian Gynaecological Endoscopy & Surgery Society, Committee Hansard, 18 September 2017, p. 30.

[59]      Committee Hansard, 3 August 2017, p. 36.

[60]      Community Affairs References Committee, Inquiry into the regulatory standards for the approval of medical devices in Australia, 22 November 2011, https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Completed_inquiries/2010-13/medicaldevices/report/index.

[61]      Medical Technology Association of Australia (MTAA), Submission 40, pp. 2-3.

[62]      Submission 40, p. 3.

[63]      Confidential Submission 131.

[64]      Ms Val Thiesz, MTAA Director of Regulatory Affairs, Committee Hansard, 18 September 2017, p. 44.

[65]      Dr Glen Mason, Director of Medical Affairs, Johnson & Johnson Medical Devices, Committee Hansard, 18 September 2017, p. 41.

[66]      Dr Ronald Morton, Vice-President Clinical Sciences, Urology and Pelvic Health, Boston Scientific, Committee Hansard, 18 September 2017, p. 36.

[67]      Dr Mason, Committee Hansard, 18 September 2017, p. 42.

[68]      Dr Mason, Committee Hansard, 18 September 2017, p. 46.

[69]      Ms Val Thiesz, Director of Regulatory Affairs, MTAA, Committee Hansard, 18 September 2017, p. 46.

[70]      Mr Ian Burgess, Chief Executive Officer, MTAA, Committee Hansard, 18 September 2017, p. 46.

[71]      RANZCOG, Submission 36, p. 4.

[72]      Submission 36.1, p. 5. Medibank notes that private health insurance funds two in every five hospital admissions in Australia, and the majority of elective surgeries are performed in private hospitals. As it has a 28 per cent share of the private health insurance market, through its Medibank and ahm brands, the data it holds constitutes is a representative sample.

[73]      RANZCOG, Submission 36.1, p. 4. Medibank advises that this analysis sets aside the data sets for the years 2014 to 2016 which are incomplete as the follow up period of three years has not been fully completed.

[74]      Medibank notes that the reasons for a device not being on the Prostheses List include a device not being TGA registered or not being provisioned by the Prostheses List Advisory Committee for inclusion on the Prostheses List. Submission 36.1, p. 4.

[75]      Submission 36.1, pp. 4-5.

[76]      See, for example: Dr Anna Rosamilia, Urogynaecologist, Monash Health, Committee Hansard, 3 August 2017, p. 37; Associate Professor Jason Abbott, Committee Hansard, 18 September 2017, p. 30; Dr Marianne Gale, Medical Adviser, Office of the Chief Health Officer, New South Wales Ministry of Health, Committee Hansard, 18 September 2017, p. 55.

[77]      Urogynaecological Society of Australia, UGSA Pelvic Floor Database, http://www.ugsa.org.au/pages/ugsa-pelvic-floor-database.html (accessed 9 February 2018).

[78]      Committee Hansard, 18 September 2017, p. 16.

[79]      RANZCOG, Submission 36, p. 4.

[80]      UGSA, Submission 32, p. 2.

[81]      Submission 36, p. 4.

[82]      Submission 36, p. 5.

[83]      Submission 36, p. 5.

[84]      Department, Submission 19, p. 16.

[85]      APMSG, Submission 130, p. 2.

[86]      Department, Submission 19, p. 14.

[87]      Department of Health, MBS Review Taskforce meeting outcomes, 20 September 2017, http://www.health.gov.au/internet/main/publishing.nsf/Content/MBSR-outcomes-20september2017 (accessed 6 February 2018).

[88]      See, for example: Dr Wendy Bonython and Mr Bruce Arnold, Submission 12, p. [5]; Australian College of Midwives, Submission 16, p. 3.

[89]      Kathryn, Committee Hansard, 19 September 2017, p. 4.

[90]      Dr Michelle Atherton, Committee Hansard, 25 August 2017, p. 32; Confidential Submission 153.1.

[91]      See, for example: Dr Caroline Dowling, Urological Society of Australia and New Zealand, Committee Hansard, 3 August 2017, p. 24; Professor Peter Laurence Dwyer, Committee Hansard, 3 August 2017, p. 36; Dr King, UGSA, Committee Hansard, 18 September 2017, p. 19; Associate Professor Jason Abbott, Committee Hansard, 18 September 2017, p. 30.

[92]      RANZCOG, answer to questions on notice, 19 September 2017, p. 2, (received 18 October 2017).

[93]      RANZCOG, answer to questions on notice, 19 September 2017, p. 2, (received 18 October 2017).

[94]      RANZCOG, answer to questions on notice, 19 September 2017, p. 2, (received 18 October 2017).

[95]      Committee Hansard, 3 August 2017, p. 34.

[96]      Professor Maher, Committee Hansard, 19 September 2017, p. 33.

[97]      Professor Maher, Committee Hansard, 19 September 2017, p. 29.

[98]      Dr Keaney, Department of Health, Committee Hansard, 19 September 2017, p. 45.

[99]      Committee Hansard, 19 September 2017, p. 47.

[100]    Mr Ian Burgess, Committee Hansard, 18 September 2017, p. 38.

[101]    Committee Hansard, 6 February 2018, p. 5.

[102]    Committee Hansard, 3 August 2017, p. 54.

[103]    Senate Community Affairs References Committee Inquiry Report, The Regulatory Standards for the Approval of Medical Devices in Australia, November 2011, Recommendation 8, p. 102.

Chapter 4 - Diagnosis, treatment and support

[1]        Dr Michelle Atherton, Committee Hansard, 25 August 2017, p. 25.

[2]        Ms Stella Channing, Director and Administrator, Australian Pelvic Mesh Support Group (APMSG), Committee Hansard, 25 August 2017, p. 3.

[3]        Between January and March 2017, the Australian Commission on Safety and Quality in Health Care (ACSQHC) undertook a series of consumer consultation forums with assistance from state health consumer councils in Brisbane, Perth and Sydney to provide women with an opportunity to speak about their experience of transvaginal mesh treatment and inform the development of patient decision support resources. Refer: ACSQHC, Consumer forums to discuss transvaginal mesh, https://www.safetyandquality.gov.au/our-work/transvaginal-mesh/consumer-forums-to-discuss-transvaginal-mesh/ (accessed 12 February 2018).

[4]        Australian Law Reform Commission, Equality, Capacity and Disability in Commonwealth Laws, 24 November 2014, p. 282, https://www.alrc.gov.au/publications/equality-capacity-disability-report-124 (accessed 23 March 2018).

[5]        Royal Australasian College of Surgeons, Surgical Mesh Consultation, Therapeutic Goods Administration, September 2017, p. [3], https://www.surgeons.org/media/25503864/2017-09-14_sbm_racs_surgical-mesh-2-.pdf (accessed 18 January 2018).

[6]        Submission 36, p, 8.

[7]        USANZ, Submission 42, p. 4.

[8]        Submission 42, p. 4.

[9]        Submission 42, p. 4.

[10]      Urogynaecology Departments, Mercy Hospital for Women, Monash Health, Submission 44, pp. [1-2]; see also Monash Health, Submission 47, pp. [2-3].

[11]      Urogynaecological Society of Australasia (UGSA), Submission 32, p. 4. See also: Attachments 1-15.

[12]      Committee Hansard, 18 September 2017, p. 30.

[13]      Australian College of Midwives (ACM), Submission 16, p. 1.

[14]      Submission 16, p. 2.

[15]      Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Polypropylene vaginal mesh implants for vaginal prolapse, https://www.ranzcog.edu.au/getattachment/Statements-Guidelines/Gynaecology/Polypropylene-Vaginal-Mesh-Implants-for-Vaginal-Pr/Polypropylene-vaginal-mesh-implants-for-vaginal-prolapse-(C-Gyn-20)-Jan18.pdf?lang=en-AU&ext=.pdf (accessed 7 March 2018).

[16]      Committee Hansard, 25 August 2017, p. 5.

[17]      Health Consumers Councils across Australia (HCCs), Submission 21, p. 6.

[18]      Senate Community Affairs References Committee, The role of the Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prothese (PIP) breast implants, 31 May 2012.

[19]      HCCs, Submission 21, p. 6.

[20]      Submission 21, p. 7.

[21]      Associate Professor Jason Abbott, President of the Australasian Gynaecological Endoscopy and Surgery Society, Committee Hansard, 18 September 2017, p. 30.

[22]      Dr Jane Manning, Submission 453, p. [1].

[23]      Name withheld, Submission 295.

[24]      See, for example: Name withheld, Submission 60; Name withheld, Submission 66; Name withheld, Submission 67; Name withheld, Submission 68; Name withheld, Submission 86; Name withheld, Submission 87; Name withheld, Submission 206; Name withheld, Submission 472.

[25]      Name withheld, Submission 110, p. [3].

[26]      See, for example: Name withheld, Submission 113, p. 1; Name withheld, Submission 133, p. 1; Name withheld, Submission 149, p. 3.

[27]      Name withheld, Submission 81, p. 1.

[28]      See, for example: Name withheld, Submission 418, p. 2 and p. 12.

[29]      Name withheld, Submission 85, p.1.

[30]      See, for example: Name withheld, Submission 58, p. [1]; Name withheld, Submission, 80, p. [1]; Name withheld, Submission 87, p. [2]; Name withheld, Submission 103; p. [1].

[31]      Name withheld, Submission 105, p. [7].

[32]      Name withheld, Submission 67, p. 1.

[33]      See, for example: Name withheld, Submission 528, p. 1; Name withheld, Submission 29, p. 1; Name withheld, Submission 52; Name withheld, Submission 122, p.2; Name withheld, Submission 147, p. [1].

[34]      Mr Danny Vadasz, Chief Executive Officer, Health Issues Centre, Committee Hansard, 3 August 2017, pp. 19-20.

[35]      See, for example: Mr Danny Vadasz, Chief Executive Officer, Health Issues Centre, Victoria, Committee Hansard, 3 August 2017, p. 19; Name withheld, Submission 147, p. 1; Name withheld, Submission 206, p. 3; Name withheld, Submission 523, p. 1.

[36]      Name withheld, Submission 461, p. 1.

[37]      Name withheld, Submission 122, p. 3.

[38]      Name withheld, Submission 122, p. 2.

[39]      Name withheld, Submission 528, p. [1].

[40]      Name withheld, Submission 150, p. 2.

[41]      Name withheld, Submission 550, p. [1].

[42]      Name withheld, Submission 92, p. 1.

[43]      See, for example: Name withheld, Submission 58, p. [1], Name withheld, Submission 390, p. [1]; Name withheld, Submission 424, p. 8.

[44]      Name withheld, Submission 113, p. 1.

[45]      Name withheld, Submission 390, p. 1.

[46]      See, for example: Name withheld, Submission 113, pp. [1-2]; Name withheld, Submission 133, p. [2]; Name withheld, Submission 206, pp. 4, 10; Name withheld, Submission 265, p. 2; Name withheld, Submission 340, p. [12]; Name withheld, Submission 424, p. 3; Name withheld, Submission 498, p. [4]; Name withheld, Submission 512, pp. 3-4.

[47]      Name withheld, Submission 222, p. 4.

[48]      Associate Professor Angela Dawson, Convenor of the Women's Health Special Interest Group, Public Health Association of Australia (PHAA), Committee Hansard, 3 August 2017, p. 8.

[49]      See, for example: Name withheld, Submission 102, p. [2]; Name withheld, Submission 105, p. [3]; Name withheld, Submission 108, p. 2; Name withheld, Submission 293, p. 4; Name withheld, Submission 328, p. 3; Name withheld, Submission 424, p. 3.

[50]      Name withheld, Submission 467, p. 3.

[51]      Name withheld, Submission 111, p. [2].

[52]      Name withheld, Submission 118, p. 6.

[53]      See, for example: Professor Hans Peter Dietz, Associate Professor Clara Shek and Dr Vivien Wong, Submission 1, p. 5; The Continence Foundation of Australia (CFA), Submission 35, p. 2; USANZ, Submission 42, Attachment 1, p. [1]; Dr Anna Rosamilia, Urogynaecologist, Monash Health, Committee Hansard, 3 August 2017, p. 33.

[54]      Professor Jason Abbott, Committee Hansard, 18 September 2017, p. 31.

[55]      Professor Hans Peter Dietz, Associate Professor Clara Shek and Dr Vivien Wong, Submission 1, p. 4.

[56]      Professor Hans Peter Dietz, Committee Hansard, 25 August 2017, p 37.

[57]      Dr Jenny King, Chair, UGSA, Committee Hansard, 18 September 2017, p. 15.

[58]      Associate Professor Christopher Maher, Committee Hansard, 19 September 2017, p. 30.

[59]      Associate Professor Christopher Maher, Committee Hansard, 19 September 2017, p. 30.

[60]      Associate Professor Christopher Maher, Committee Hansard, 19 September 2017, p. 30.

[61]      Monash Health, Submission 47, p. [1].

[62]      Submission 47, p. [1].

[63]      RANZCOG, Submission 36, p. 1.

[64]      Continence Foundation of Australia (CFA), Submission 35, p. 1.

[65]      Dr Alison De Souza, Urogynaecologist, Mercy Hospital for Women, Committee Hansard, 3 August 2017, p. 30.

[66]      CFA, Submission 35, p. 1.

[67]      Submission 36, p. 9.

[68]      See, for example: Name withheld, Submission 146, p. [1]; Name withheld, Submission 147, p. [1].

[69]      Dr Michelle Atherton, Committee Hansard, 25 August 2017, p. 26.

[70]      Dr Alison De Souza, Committee Hansard, 3 August 2017, p. 30.

[71]      Dr Michelle Atherton, Committee Hansard, 25 August 2017, p. 26.

[72]      Dr Michelle Atherton, Committee Hansard, 25 august 2017, p. 26.

[73]      Adjunct Professor Debora Picone, Chief Executive Officer, ACSQHC, Committee Hansard, 19 September 2017, p. 7.

[74]      Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT), Published 20 December 2016, and Cochrane Review and International Collaboration on Incontinence, The surgical management of pelvic organ prolapse in women, published in November 2016, evaluated 3332 surgeries.

[75]      Adjunct Professor John Skerritt, Deputy Secretary, Therapeutic Goods Administration, and Mr Tim Greenaway, First Assistant Secretary, Therapeutic Goods Administration, Committee Hansard, 3 August 2017, p. 50.

[76]      Ms Adriana Platona, First Assistant Secretary, Therapeutic Goods Administration, Committee Hansard, 3 August 2017, p. 50.

[77]      Committee Hansard, 3 August 2017, pp. 22-23.

[78]      See, for example: Name withheld, Submission 103; Name withheld, Submission 524; Name withheld, Submission 545.

[79]      See, for example: Name withheld, Submission 113; Name withheld, Submission 449; Name withheld, Submission 482.

[80]      Confidential submission 465.

[81]      Dr Jenny King, Committee Hansard, 18 September 2017, p. 17.

[82]      Dr Jenny King, Committee Hansard, 18 September 2017, p. 20.

[83]      See, for example: Name withheld, Submission 111; Name withheld, Submission 393.

[84]      Neotonus chair therapy employs pulsing magnetic fields to stimulate nerve activity in the pelvic floor, which in turn exercises the muscles that control bladder function.

[85]      Name withheld, Submission 523, p. [2].

[86]      Name withheld, Submission 523, p. [3].

[87]      Name withheld, Submission 324, p. 4.

[88]      RANZCOG, Submission 36, p. 8.

[89]      Professor Thierry Vancaillie, Director, Women's Health and Research Institute of Australia, Committee Hansard, 18 September 2017, p. 7.

[90]      See, for example: Name withheld, Submission 110, p. [3]; Name withheld, Submission 182, p. [1]; Name withheld, Submission 527; Name withheld, Submission 549, p. [3].

[91]      Name withheld, Submission 552.

[92]      Name withheld, Submission 524.

[93]      Confidential Submission 465.

[94]      See, for example: Name withheld, Submission 67, p. [4]; Name withheld, Submission 102, p. [1]; Name withheld, Submission 396; Name withheld, Submission 397.

[95]      Name withheld, Submission 430, p. 4.

[96]      Name withheld, Submission 487, p. 2.

[97]      Committee Hansard, 25 August 2017, p. 3.

[98]      Ms Stella Channing, Committee Hansard, 25 August 2017, p. 3.

[99]      Ms Stella Channing, Committee Hansard, 25 August 2017, p. 3.

[100]    Name withheld, Submission 451, p. 5.

[101]    Committee Hansard, 25 August 2017, p. 4.

[102]    Name withheld, Submission 147, pp. [2-5].

[103]    Name withheld, Submission 139, pp. [2-3].

[104]    Mrs Charlotte Korte, Lead Representative, Mesh Down Under, Committee Hansard, 25 August 2017, p. 13.

[105]    Dr Magdalena Simonis, Member, Expert Committee, Quality Care, Royal Australian College of General Practitioners, Committee Hansard, 19 September 2017, p. 13.

[106]    See, for example: Name withheld, Submission 72, p. [1]; Andrea, Committee Hansard, 3 August 2017, p. 2; Professor Thierry Vancaillie, Committee Hansard, 6 February 2018, p. 2.

[107]    Name withheld, Submission 464, pp. 1-2.

[108]    Dr Magdalena Simonis, Committee Hansard, 19 September 2017, p. 14.

[109]    Dr Magdalena Simonis, Committee Hansard, 19 September 2017, p. 13.

[110]    Name withheld, Submission 523, p. [3].

[111]    See, for example: Name withheld, Submission 29, p. [1]; Name withheld, Submission 108, p. 10; Name withheld, Submission 113, pp. [1, 4]; Name withheld, Submission 114.1, p. 2.

[112]    See, for example: Name withheld, Submission 108; Name withheld, Submission 111, p. 4; Name withheld, Submission 119, p. 8; Name withheld, Submission 155, p. 4.

[113]    Name withheld, Submission 102, p. 1.

[114]    Professor Peter Dwyer, Committee Hansard, 3 August 2017, p. 37.

[115]    Urogynaecology Departments, Mercy Hospital for Women, Monash Health, Submission 44, p. [3].

[116]    Dr Anna Rosamilia, Committee Hansard, 3 August 2017, p. 34.

[117]    See, for example: Name withheld, Submission 103, p. [2]; APMSG, Submission 130, p. 2; Kim, Committee Hansard, 3 August 2017; p. 2; Andrea, Committee Hansard, 3 August 2017; p. 2; Joanne, Committee Hansard, 18 September 2017, p. 2.

[118]    See, for example: Name withheld, Submission 112, [2]; Name withheld, Submission 521, p. [3].

[119]    See, for example: Submission 102, p. 5; Name withheld, Submission 498, p. [9].

[120]    See, for example: Name withheld, Submission 134, p. [3]; Name withheld, Submission 137; Name withheld, Submission 538, p. [1]; Melinda, Committee Hansard, 3 August 2017, p. 14.

[121]    See, for example: Name withheld, Submission, 137; Name withheld, Submission 554.

[122]    Submission 36, p. 10.

[123]    Name withheld, Submission 81, p. [1].

[124]    Submission 36, p. 10.

[125]    National Association of Specialist Obstetricians and Gynaecologists, Submission 49, p. [3].

[126]    Committee Hansard, 18 September 2017, pp. 8-9.

Chapter 5 - Responding to the evidence

[1]        Ms Josephine Root, Policy Manager, Consumers Health Forum of Australia, Committee Hansard, 3 August 2017, p. 16.

[2]        Associate Professor Angela Dawson, Convenor of the Women's Health Special Interest Group, Public Health Association of Australia, Committee Hansard, 3 August 2017, p. 8.

[3]        See, for example: Health Consumers Councils across Australia, Submission 23; Consumers Health Forum of Australia, Submission 26; Health Issues Centre, Submission 115, Australian Pelvic Mesh Support Group, Submission 140.

[4]        Adjunct Professor John Skerritt, Deputy Secretary, Therapeutic Goods Administration, Committee Hansard, 6 February 2018, p. 2.

[5]        Committee Hansard, 3 August 2017, p. 50.

[6]        Department of Health (Department), Submission 19, p. 5.

[7]        See, for example: APMSG, Submission 130, p. 23; Associate Professor Christopher Maher, Submission 154, p. [10]; Kathryn, Committee Hansard, 19 September 2017, p. 4.

[8]        Dr Tim Greenaway, First Assistant Secretary, Therapeutic Goods Administration (TGA), Committee Hansard, 19 September 2017, p. 45.

[9]        See, for example: RANZCOG, Submission 36, p. 11; Health Issues Centre, Submission 115, p. 25; Name withheld, Submission 28, p. 2; Name withheld, Submission 101, p. [2]; Chantal, Committee Hansard, 3 August 2017, p. 24; Kathryn, Committee Hansard, 19 September 2017, p. 4.

[10]      Adjunct Professor John Skerritt, Committee Hansard, 3 August 2017, p. 46.

[11]      Adjunct Professor John Skerritt, Committee Hansard, 6 February 2018, p. 10.

[12]      See, for example: Dr Anna Rosamilia, Urogynaecologist, Monash Health Committee Hansard, 3 August 2017, p. 34; Professor Robson, President, Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Committee Hansard, 19 September, pp. 22-23.

[13]      See, for example: APMSG, Submission 130, p. 23; Associate Professor Christopher Maher, Submission 154, p. [10].

[14]      Ms Adriana Platona, First Assistant Secretary, TGA, Committee Hansard, 19 September 2017, p. 45.

[15]      Committee Hansard, 6 February 2018, p. 3.

[16]      Ms Adriana Platona, Committee Hansard, 19 September 2017, p. 49.

[17]      The, government accepted the recommendation of the 2015 Review of Medicines and Medical Devices Regulation (MMDR Review) that the TGA should align itself more closely with the European Union regulatory framework in September 2016.

[18]      Department of Health, Therapeutic Goods Administration, Strengthening the assessment of medical devices and information for consumers, 26 October 2017, https://www.tga.gov.au/media-release/strengthening-assessment-medical-devices-and-information-consumers (accessed 19 March 2018).

[19]      Department of Health, Therapeutic Goods Administration, Strengthening the assessment of medical devices and information for consumers, 26 October 2017, https://www.tga.gov.au/media-release/strengthening-assessment-medical-devices-and-information-consumers (accessed 19 March 2018).

[20]      Adjunct Professor John Skerritt, Committee Hansard, 6 February 2018, p. 5.

[21]      Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017, Explanatory Statement, p. 4.

[22]      Explanatory Statement, pp. 4-5.

[23]      Department, Submission 19, Attachment 1, pp. 32-34.

[24]      Department of Health, Therapeutic Goods Administration , 'TGA undertakes regulatory actions after review into urogynaecological surgical mesh implants', Media release, 30 November 2017; Adjunct Professor Skerritt, Committee Hansard, 6 February 2018, p. 2.

[25]      Department of Health, Therapeutic Goods Administration, TGA actions after review into urogynaecological surgical mesh implants, 22 December 2017, https://www.tga.gov.au/node/768243 (accessed 23 March 2018).

[26]      Adjunct Professor Debora Picone, Chief Executive Officer, Australian Commission on Safety and Quality in Health Care, Committee Hansard, 19 September 2017, p. 7.

[27]      Department of Health, Therapeutic Goods Administration, TGA actions after review into urogynaecological surgical mesh implants, 22 December 2017.

[28]      Committee Hansard, 6 February 2018, p. 3.

[29]      Committee Hansard, 6 February 2018, p. 2.

[30]      Adjunct Professor John Skerritt, Committee Hansard, 6 February 2018, pp. 2-3.

[31]      Committee Hansard, 6 February 2018, p. 3.

[32]      Committee Hansard, 6 February 2018, p. 3.

[33]      Adjunct Professor John Skerritt, Committee Hansard, 3 August 2017, p. 47.

[34]      Adjunct Professor John Skerritt, Committee Hansard, 6 February 2018, p. 6.

[35]      Dr Tim Greenaway, Committee Hansard, 6 February 2018, p. 7.

[36]      Committee Hansard, 19 September 2017, p. 20.

[37]      MMDR Review, Report on the regulatory framework for medicines and medical devices, March 2015, p. 126.

[38]      MMDR Review, Report on the regulatory framework for medicines and medical devices, March 2015, p. 127.

[39]      MMDR Review, Report on the regulatory framework for medicines and medical devices, March 2015, p. 129.

[40]      Department of Health, Australian Government Response to the Review of Medicines and Medical Devices Regulation, 15 September 2016, p. 21, http://www.health.gov.au/internet/main/publishing.nsf/Content/MMD-govresp (accessed 20 March 2018).

[41]      Adjunct Professor John Skerritt, Committee Hansard, 3 August 2017, p. 54; Mr Ian Burgess, Chief Executive Office, Medical Technology Association of Australia, Committee Hansard, 18 September 2017, pp. 38, 47; Adjunct Professor John Skerritt, Committee Hansard, 6 February 2018, p. 5.

[42]      Release of the report for public consultation was endorsed by the MBS Taskforce at its meeting on 20 September 2017. See: Department of Health, MBS Review Taskforce meeting outcomes, 20 September 2017, http://www.health.gov.au/internet/main/publishing.nsf/Content/MBSR-outcomes-20september2017 (accessed 22 March 2018).

[43]      MMDR Review, Report on the regulatory framework for medicines and medical devices, March 2015, p. 160.

[44]      Department of Health, Australian Government Response to the Review of Medicines and Medical Devices Regulation, 15 September 2016, p. 24, http://www.health.gov.au/internet/main/publishing.nsf/Content/MMD-govresp (accessed 20 March 2018).

[45]      ACSQHC, Submission 46, p. 4.

[46]      See, for example: Dr Gary Swift, President, National Association of Specialist Obstetricians and Gynaecologists (NASOG), Committee Hansard, 3 August 2017, p. 29; Dr Caroline Dowling, Urologist, Urological Society of Australia and New Zealand, Committee Hansard, 3 August 2017, p. 27; Dr Michelle Atherton, Committee Hansard, 25 August 2018, p. 30.

[47]      ACSQHC Update, additional information received 6 February 2018, p. [1].

[48]      ACSQHC, Update, additional information received 6 February 2018, p. [2].

[49]      ACSQHC, Submission 46, p. 4.

[50]      Submission 46, p. 4.

[51]      ACSQHC, Submission 46, pp. 4-5.

[52]      ACSQHC Update, additional information received 6 February 2018, p. [2].

[53]      Professor Stephen Robson, Committee Hansard, 19 September 2018, p. 19.

[54]      ACSQHC Update, additional information received 6 February 2018, p. [2].

[55]      Associate Professor Maher, Committee Hansard, 19 September 2017, pp. 29-30.

[56]      Professor Stephen Robson, Committee Hansard, 19 September 2017, p. 19.

[57]      See, for example: Urogynaecological Society of Australasia, Submission 32; Urological Society of Australia and New Zealand, Submission 42; NASOG, Submission 49; Australasian Gynaecological Endoscopy and Surgery Society Limited, Submission 18.

[58]      Associate Professor Jason Abbott, President, Australasian Gynaecological Endoscopy and Surgery Society, Committee Hansard, 18 September 2017, p. 30.

[59]      Committee Hansard, 18 September 2017, p. 30.

[60]      Confidential Submission 153.

[61]      Monash Health, Submission 47, p. [2].

[62]      See, for example: Professor Picone, Committee Hansard, 3 August 2017, pp. 40-41; Dr Jenny King, Chair, UroGynaecological Society of Australasia, Committee Hansard, 18 September 2017, pp. 16, 23; Professor Stephen Robson, Committee Hansard, 19 September 2017, pp. 19-20.

[63]      Committee Hansard, 19 September 2017, pp. 19-20.

[64]      Submission 46, p. 6.

[65]      ACSQHC Update, additional information received 6 February 2018, p. [2].

[66]      ACSQHC, Submission 46, p. 6.

[67]      ACSQHC Update, additional information received 6 February 2018, p. [2].

[68]      ACSQHC Update, additional information received 6 February 2018, p. [2].

[69]      See, for example: Public Health Association Australia, Submission 20, p. 5; TFS Surgical, Submission 22; Johnson & Johnson Medical Pty Ltd, Submission 23; pp. 14-15; Associate Professor Christopher Maher, Submission 154, p. [13].

[70]      Submission 21, p. 8.

[71]      Submission 130, pp. 5-6.

[72]      Medical Board of Australia, Good Medical Practice: A code of conduct for doctors in Australia, March 2014, http://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of-conduct.aspx (accessed 23 March 2018).

[73]      Mr Gavin Fox-Smith, Managing Director, Johnson & Johnson Medical Devices, Committee Hansard, 18 September 2017, p. 36; Mr Pat Callanan, Business Unit Director Australia and New Zealand, Urology and Pelvic Health, Boston Scientific, Committee Hansard, 18 September 2017, p. 37.

[74]      MTAA, Submission 40, p. 4.

[75]      MTAA, Submission 40, p. 4.

[76]      Committee Hansard, 18 September 2017, p. 45.

[77]      Senate Community Affairs References Committee, The regulatory standards for the approval of medical devices in Australia, 22 November 2011, p. 106.

[78]      Kim, Committee Hansard, 3 August 2017, pp. 3-4.

[79]      ACSQHC Update, additional information received 6 February 2018, p. [3].

[80]      ACSQHC Update, additional information received 6 February 2018, p. [3].

[81]      Government of Western Australia, The Hon Roger Cook, Deputy Premier, Minister for Health, Mental Health, 'New Phone line to help WA women affected by mesh implants', Media release, 8 September 2017, https://www.mediastatements.wa.gov.au/Pages/McGowan/2017/09/New-phone-line-to-help-WA-women-affected-by-mesh-implants.aspx (accessed 1 February 2018).

[82]      Western Australian Department of Health, Healthy WA health information for Western Australians, Pelvic Mesh, http://healthywa.wa.gov.au/Articles/N_R/Pelvic-mesh (accessed 1 February 2018).

[83]      Victorian Minister for Health, The Hon Jill Hennessy, 'Transvaginal Mesh Support for Victorian Women', Media release, 19 December 2017, https://www.premier.vic.gov.au/transvaginal-mesh-support-for-victorian-women/ (accessed 1 February 2018).

[84]      Victorian State Government, Better Health Channel, Transvaginal mesh, https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/Transvaginal-mesh (accessed 1 February 2018).

[85]      Dr Kerry Chant, Committee Hansard, 18 September 2017, p. 53.

[86]      Dr Marianne Gale, Medical Adviser, Office of the Chief Health Officer, New South Wales Ministry of Health, Committee Hansard, 18 September 2017, p. 54.

[87]      Dr Kerry Chant, Committee Hansard, 18 September 2017, p. 53.

[88]      NSW Government, Safety Notice 015/17, Transvaginal mesh implants for Pelvic Organ (Vaginal Prolapse), 20 December 2017, http://www.health.nsw.gov.au/sabs/Pages/default.aspx (accessed 17 January 2018).

[89]      ACT Government, ACT Health, Transvaginal Mesh, 9 January 2018, http://www.health.act.gov.au/node/8925 (accessed 9 February 2018).