Lay experts and the politics of breast implants

Public Understanding of Science

Volumn 12, Issue 4, 2003, Pages 403-421

  Kent, Julie ^a  

^a UNIVERSITY OF THE WEST OF ENGLAND   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BREAST ENDOPROSTHESIS; EUROPE; EXPERT WITNESS; HEALTH CARE AND PUBLIC HEALTH; HEALTH CARE POLICY; HISTORY; POLITICS; REVIEW; UNITED KINGDOM; UNITED STATES;

HEALTH CARE AND PUBLIC HEALTH;

BREAST IMPLANTS; EUROPE; EXPERT TESTIMONY; GREAT BRITAIN; HEALTH POLICY; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; POLITICS; UNITED STATES;

EID: 0347569218     PISSN: 09636625     EISSN: None     Source Type: Journal    
DOI: 10.1177/0963662503124005     Document Type: Review

References (119)

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2. B. Wynne, "Misunderstood misunderstanding: social identities and the public uptake of science," Public Understanding of Science 1 (1992): 281-304; A. Grinyer, "Risk, the real world and naïve sociology: perceptions of risk from occupational injury in the health service," in Medicine, Health and Risk Sociological Approaches, ed. J. Gabe (Oxford: Blackwells, 1995), 31-52; A. Irwin, Citizen Science (London: Routledge,1995).
3. B. Wynne, "Misunderstood misunderstanding: social identities and the public uptake of science," Public Understanding of Science 1 (1992): 281-304; A. Grinyer, "Risk, the real world and naïve sociology: perceptions of risk from occupational injury in the health service," in Medicine, Health and Risk Sociological Approaches, ed. J. Gabe (Oxford: Blackwells, 1995), 31-52; A. Irwin, Citizen Science (London: Routledge,1995).
4. R. Merkatz et al., "A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants," Journal of Women's Health 2, no. 2 (1993): 105-109; N. Handel et al., "Knowledge, concern and satisfaction among augmentation mammaplasty patients," Annals of Plastic Surgery 30 (1993): 13-20; A. Park et al., "Patient satisfaction following insertion of silicone breast implants," British Journal of Plastic Surgery 49 (1996): 515-518; S. L. Hovi et al., "Cosmetic and postmastectomy breast implants: Finnish women's experiences," Journal of Women's Health & Gender-based Medicine 8 September, no. 7 (1999): 933-939; D. Harcourt and N. Rumsey, "Psychological aspects of breast reconstruction: a review of the literature," Journal of Advanced Nursing 35, no. 4 (2001): 477-487; D. Harcourt et al., "Breast augmentation and reduction: women's decision making process, information needs, satisfaction with outcome and psychological well-being following surgery" (unpublished).
5. R. Merkatz et al., "A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants," Journal of Women's Health 2, no. 2 (1993): 105-109; N. Handel et al., "Knowledge, concern and satisfaction among augmentation mammaplasty patients," Annals of Plastic Surgery 30 (1993): 13-20; A. Park et al., "Patient satisfaction following insertion of silicone breast implants," British Journal of Plastic Surgery 49 (1996): 515-518; S. L. Hovi et al., "Cosmetic and postmastectomy breast implants: Finnish women's experiences," Journal of Women's Health & Gender-based Medicine 8 September, no. 7 (1999): 933-939; D. Harcourt and N. Rumsey, "Psychological aspects of breast reconstruction: a review of the literature," Journal of Advanced Nursing 35, no. 4 (2001): 477-487; D. Harcourt et al., "Breast augmentation and reduction: women's decision making process, information needs, satisfaction with outcome and psychological well-being following surgery" (unpublished).
6. R. Merkatz et al., "A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants," Journal of Women's Health 2, no. 2 (1993): 105-109; N. Handel et al., "Knowledge, concern and satisfaction among augmentation mammaplasty patients," Annals of Plastic Surgery 30 (1993): 13-20; A. Park et al., "Patient satisfaction following insertion of silicone breast implants," British Journal of Plastic Surgery 49 (1996): 515-518; S. L. Hovi et al., "Cosmetic and postmastectomy breast implants: Finnish women's experiences," Journal of Women's Health & Gender-based Medicine 8 September, no. 7 (1999): 933-939; D. Harcourt and N. Rumsey, "Psychological aspects of breast reconstruction: a review of the literature," Journal of Advanced Nursing 35, no. 4 (2001): 477-487; D. Harcourt et al., "Breast augmentation and reduction: women's decision making process, information needs, satisfaction with outcome and psychological well-being following surgery" (unpublished).
7. R. Merkatz et al., "A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants," Journal of Women's Health 2, no. 2 (1993): 105-109; N. Handel et al., "Knowledge, concern and satisfaction among augmentation mammaplasty patients," Annals of Plastic Surgery 30 (1993): 13-20; A. Park et al., "Patient satisfaction following insertion of silicone breast implants," British Journal of Plastic Surgery 49 (1996): 515-518; S. L. Hovi et al., "Cosmetic and postmastectomy breast implants: Finnish women's experiences," Journal of Women's Health & Gender-based Medicine 8 September, no. 7 (1999): 933-939; D. Harcourt and N. Rumsey, "Psychological aspects of breast reconstruction: a review of the literature," Journal of Advanced Nursing 35, no. 4 (2001): 477-487; D. Harcourt et al., "Breast augmentation and reduction: women's decision making process, information needs, satisfaction with outcome and psychological well-being following surgery" (unpublished).
8. R. Merkatz et al., "A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants," Journal of Women's Health 2, no. 2 (1993): 105-109; N. Handel et al., "Knowledge, concern and satisfaction among augmentation mammaplasty patients," Annals of Plastic Surgery 30 (1993): 13-20; A. Park et al., "Patient satisfaction following insertion of silicone breast implants," British Journal of Plastic Surgery 49 (1996): 515-518; S. L. Hovi et al., "Cosmetic and postmastectomy breast implants: Finnish women's experiences," Journal of Women's Health & Gender-based Medicine 8 September, no. 7 (1999): 933-939; D. Harcourt and N. Rumsey, "Psychological aspects of breast reconstruction: a review of the literature," Journal of Advanced Nursing 35, no. 4 (2001): 477-487; D. Harcourt et al., "Breast augmentation and reduction: women's decision making process, information needs, satisfaction with outcome and psychological well-being following surgery" (unpublished).
9. R. Merkatz et al., "A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants," Journal of Women's Health 2, no. 2 (1993): 105-109; N. Handel et al., "Knowledge, concern and satisfaction among augmentation mammaplasty patients," Annals of Plastic Surgery 30 (1993): 13-20; A. Park et al., "Patient satisfaction following insertion of silicone breast implants," British Journal of Plastic Surgery 49 (1996): 515-518; S. L. Hovi et al., "Cosmetic and postmastectomy breast implants: Finnish women's experiences," Journal of Women's Health & Gender-based Medicine 8 September, no. 7 (1999): 933-939; D. Harcourt and N. Rumsey, "Psychological aspects of breast reconstruction: a review of the literature," Journal of Advanced Nursing 35, no. 4 (2001): 477-487; D. Harcourt et al., "Breast augmentation and reduction: women's decision making process, information needs, satisfaction with outcome and psychological well-being following surgery" (unpublished).
10. K. Davis, Reshaping the Female Body: the Dilemma of Cosmetic Surgery (London: Routledge, 1995).
11. Ibid., p. 5.
12. Ibid., p. 141.
13. Ibid., p. 148.
14. Ibid., p. 149.
15. Ibid., p. 152.
16. J. Stacey, Teratologies: a Cultural Study of Cancer (London: Routledge, 1997).
17. M. Vanderford and D. Smith, The Silicone Breast Implant Story: Communication and Uncertainty (New Jersey: Lawrence Erlbaum Associates, 1996); S. Zimmerman, Silicone Survivors: Women's Experiences with Breast Implants (Philadelphia: Temple University, 1998); M. White Stewart, Silicone Spills: Breast Implants on Trial (London: Praeger Publishers, 1998); N. Jacobson, Cleavage: Technology, Controversy and the Ironies of the Man-Made Breast (New Jersey: Rutgers University Press, 2000).
18. M. Vanderford and D. Smith, The Silicone Breast Implant Story: Communication and Uncertainty (New Jersey: Lawrence Erlbaum Associates, 1996); S. Zimmerman, Silicone Survivors: Women's Experiences with Breast Implants (Philadelphia: Temple University, 1998); M. White Stewart, Silicone Spills: Breast Implants on Trial (London: Praeger Publishers, 1998); N. Jacobson, Cleavage: Technology, Controversy and the Ironies of the Man-Made Breast (New Jersey: Rutgers University Press, 2000).
19. M. Vanderford and D. Smith, The Silicone Breast Implant Story: Communication and Uncertainty (New Jersey: Lawrence Erlbaum Associates, 1996); S. Zimmerman, Silicone Survivors: Women's Experiences with Breast Implants (Philadelphia: Temple University, 1998); M. White Stewart, Silicone Spills: Breast Implants on Trial (London: Praeger Publishers, 1998); N. Jacobson, Cleavage: Technology, Controversy and the Ironies of the Man-Made Breast (New Jersey: Rutgers University Press, 2000).
20. M. Vanderford and D. Smith, The Silicone Breast Implant Story: Communication and Uncertainty (New Jersey: Lawrence Erlbaum Associates, 1996); S. Zimmerman, Silicone Survivors: Women's Experiences with Breast Implants (Philadelphia: Temple University, 1998); M. White Stewart, Silicone Spills: Breast Implants on Trial (London: Praeger Publishers, 1998); N. Jacobson, Cleavage: Technology, Controversy and the Ironies of the Man-Made Breast (New Jersey: Rutgers University Press, 2000).
21. N. Bruning, Breast Implants: Everything You Need to Know (Emeryville, Canada: Hunter House, Alameda, 1995).
22. Vanderford and Smith, The Silicone Breast Implant Story, p. 25.
23. Ibid., p. 33.
24. Ibid., p. 49.
25. Ibid., p. 57.
26. There are a wide range of implant types on the market, and although all usually have silicone elastomer shells, the focus of the silicone controversy is the effect of silicone gel in the body. There is a growing literature on the clinical outcomes of different types of implants - see, for example: J. Sanchez-Guerrero et al., "Silicone breast implants and the risk of connective tissue disease and symptoms," The New England Journal of Medicine 332, no. 25 (1995): 1666-1670; R. Iwuagwu and J. Frame, "Silicone breast implants: complications," British Journal of Plastic Surgery 50, no. 8 (1997): 632-636; S. Choudhary et al., "Local tissue reactions to oil-based implant bleed," British Journal of Plastic Surgery 53, no. 4 (2000): 317-318; N. Collis et al., "Ten-year review of a prospective randomised controlled trial of textured versus smooth sub-glandular silicone gel breast implants," Plastic & Reconstructive Surgery 106, (2000): 1979-1985.
27. There are a wide range of implant types on the market, and although all usually have silicone elastomer shells, the focus of the silicone controversy is the effect of silicone gel in the body. There is a growing literature on the clinical outcomes of different types of implants - see, for example: J. Sanchez-Guerrero et al., "Silicone breast implants and the risk of connective tissue disease and symptoms," The New England Journal of Medicine 332, no. 25 (1995): 1666-1670; R. Iwuagwu and J. Frame, "Silicone breast implants: complications," British Journal of Plastic Surgery 50, no. 8 (1997): 632-636; S. Choudhary et al., "Local tissue reactions to oil-based implant bleed," British Journal of Plastic Surgery 53, no. 4 (2000): 317-318; N. Collis et al., "Ten-year review of a prospective randomised controlled trial of textured versus smooth sub-glandular silicone gel breast implants," Plastic & Reconstructive Surgery 106, (2000): 1979-1985.
28. There are a wide range of implant types on the market, and although all usually have silicone elastomer shells, the focus of the silicone controversy is the effect of silicone gel in the body. There is a growing literature on the clinical outcomes of different types of implants - see, for example: J. Sanchez-Guerrero et al., "Silicone breast implants and the risk of connective tissue disease and symptoms," The New England Journal of Medicine 332, no. 25 (1995): 1666-1670; R. Iwuagwu and J. Frame, "Silicone breast implants: complications," British Journal of Plastic Surgery 50, no. 8 (1997): 632-636; S. Choudhary et al., "Local tissue reactions to oil-based implant bleed," British Journal of Plastic Surgery 53, no. 4 (2000): 317-318; N. Collis et al., "Ten-year review of a prospective randomised controlled trial of textured versus smooth sub-glandular silicone gel breast implants," Plastic & Reconstructive Surgery 106, (2000): 1979-1985.
29. There are a wide range of implant types on the market, and although all usually have silicone elastomer shells, the focus of the silicone controversy is the effect of silicone gel in the body. There is a growing literature on the clinical outcomes of different types of implants - see, for example: J. Sanchez-Guerrero et al., "Silicone breast implants and the risk of connective tissue disease and symptoms," The New England Journal of Medicine 332, no. 25 (1995): 1666-1670; R. Iwuagwu and J. Frame, "Silicone breast implants: complications," British Journal of Plastic Surgery 50, no. 8 (1997): 632-636; S. Choudhary et al., "Local tissue reactions to oil-based implant bleed," British Journal of Plastic Surgery 53, no. 4 (2000): 317-318; N. Collis et al., "Ten-year review of a prospective randomised controlled trial of textured versus smooth sub-glandular silicone gel breast implants," Plastic & Reconstructive Surgery 106, (2000): 1979-1985.
30. Vanderford and Smith, The Silicone Breast Implant Story (cit. no. 10), p. 193.
31. White Stewart, Silicone Spills, (cit. no. 10); Zimmerman, Silicone Survivors (cit. no. 10).
32. White Stewart, Silicone Spills, (cit. no. 10); Zimmerman, Silicone Survivors (cit. no. 10).
33. Ibid., p. 81.
34. Capsulotomy is the term for a procedure in which the surgeon manipulates the breast externally to break the capsule. This practice has now been recognized as unsafe by many plastic surgeons and is no longer widely practiced. White Stewart, Silicone Spills (cit. no. 10), p. 112.
35. White Stewart, Silicone Spills (cit. no. 10), p. 123
36. Zimmerman, Silicone Survivors (cit. no. 10), p. 189.
37. Ibid., p. 146.
38. J. Price, G. Gates, "Junk science in the courtroom," ASSAIO 41, no. 2 (1995): 139-142; M. Angell, Science on Trial: the Clash of Medical Evidence and the Law in the Breast Implant Case (New York: Norton, 1996); Jacobsen, Cleavage (cit. no. 10).
39. J. Price, G. Gates, "Junk science in the courtroom," ASSAIO 41, no. 2 (1995): 139-142; M. Angell, Science on Trial: the Clash of Medical Evidence and the Law in the Breast Implant Case (New York: Norton, 1996); Jacobsen, Cleavage (cit. no. 10).
40. J. Price, G. Gates, "Junk science in the courtroom," ASSAIO 41, no. 2 (1995): 139-142; M. Angell, Science on Trial: the Clash of Medical Evidence and the Law in the Breast Implant Case (New York: Norton, 1996); Jacobsen, Cleavage (cit. no. 10).
41. Angell, Science on Trial.
42. Angell, Science on Trial, p. 139.
43. See also: M. Shiffman, "Silicone breast implant litigation (Part 1)," Medical Law 13, (1994): 681-716; J. Snyder "Silicone breast implants: can emerging medical, legal and scientific concepts be reconciled?," The Journal of Legal Medicine 18, (1997):133-220; D. Bernstein, "The Breast implant fiasco," California Law Review 87, (1999): 457-510.
44. See also: M. Shiffman, "Silicone breast implant litigation (Part 1)," Medical Law 13, (1994): 681-716; J. Snyder "Silicone breast implants: can emerging medical, legal and scientific concepts be reconciled?," The Journal of Legal Medicine 18, (1997):133-220; D. Bernstein, "The Breast implant fiasco," California Law Review 87, (1999): 457-510.
45. See also: M. Shiffman, "Silicone breast implant litigation (Part 1)," Medical Law 13, (1994): 681-716; J. Snyder "Silicone breast implants: can emerging medical, legal and scientific concepts be reconciled?," The Journal of Legal Medicine 18, (1997):133-220; D. Bernstein, "The Breast implant fiasco," California Law Review 87, (1999): 457-510.
46. Jacobsen, Cleavage (cit. no. 10), p. 145.
47. H. Arksey, "Expert and lay participation in the construction of medical knowledge," Sociology of Health & Illness 16, no. 4 (1994): 448-468. Arksey gives a similar account of the struggle to define repetitive strain injury as "fact."
48. Jacobsen, Cleavage, p. 170.
49. White Stewart, Silicone Spills (cit. no. 10), p. 192.
50. Vanderford and Smith, The Silicone Breast Implant Story, (cit. no. 10); Jacobsen, Cleavage.
51. Vanderford and Smith, The Silicone Breast Implant Story, (cit. no. 10); Jacobsen, Cleavage.
52. J. Tinkler et al., Medical Devices Evaluation Report: Evidence for an Association between the Implantation of Silicones and Connective Tissue, Department of Health, MDD/92/42, 65 pp. (1993); D. Gott and J. Tinkler, Silicone Implants and Connective Tissue Disease: Evaluation of Evidence for an Association between the Implantation of Silicones and Connective Tissue Disease, Medical Devices Agency, ISBN 18583 3477, 62 pp. (1994).
53. J. Tinkler et al., Medical Devices Evaluation Report: Evidence for an Association between the Implantation of Silicones and Connective Tissue, Department of Health, MDD/92/42, 65 pp. (1993); D. Gott and J. Tinkler, Silicone Implants and Connective Tissue Disease: Evaluation of Evidence for an Association between the Implantation of Silicones and Connective Tissue Disease, Medical Devices Agency, ISBN 18583 3477, 62 pp. (1994).
54. Independent Review Group, Silicone Gel Breast Implants: the Report of the Independent Review Group (http//:www.silicone-review.gov.uk) (April 1998).
55. See also: M. Yalom, A History of the Breast, (London: Harper Collins, 1997); E. Haiken, Venus Envy: a History of Cosmetic Surgery (Baltimore, Maryland: John Hopkins University Press, 1997); S. Gilman, Making the Body Beautiful: a Cultural History of Aesthetic Surgery (Princetown, New Jersey: Princeton University Press, 1999).
56. See also: M. Yalom, A History of the Breast, (London: Harper Collins, 1997); E. Haiken, Venus Envy: a History of Cosmetic Surgery (Baltimore, Maryland: John Hopkins University Press, 1997); S. Gilman, Making the Body Beautiful: a Cultural History of Aesthetic Surgery (Princetown, New Jersey: Princeton University Press, 1999).
57. See also: M. Yalom, A History of the Breast, (London: Harper Collins, 1997); E. Haiken, Venus Envy: a History of Cosmetic Surgery (Baltimore, Maryland: John Hopkins University Press, 1997); S. Gilman, Making the Body Beautiful: a Cultural History of Aesthetic Surgery (Princetown, New Jersey: Princeton University Press, 1999).
58. L. Cook et al., "Characteristics of women with and without breast augmentation," Journal of the American Medical Association 277, no. 20 (1997): 1612-1617.
59. Vanderford and Smith, The Silicone Breast Implant Story, (cit. no. 10), p. 198.
60. Ibid., p. 53-54.
61. L. Parker, "Social justice, federal paternalism, and feminism: breast implants in the cultural context of female beauty," Kennedy Institute of Ethics Journal 3, no. 1 (1993): 57-76; Jacobsen, Cleavage (cit. no. 10); Angell, Science on Trial (cit. no. 24).
62. L. Parker, "Social justice, federal paternalism, and feminism: breast implants in the cultural context of female beauty," Kennedy Institute of Ethics Journal 3, no. 1 (1993): 57-76; Jacobsen, Cleavage (cit. no. 10); Angell, Science on Trial (cit. no. 24).
63. L. Parker, "Social justice, federal paternalism, and feminism: breast implants in the cultural context of female beauty," Kennedy Institute of Ethics Journal 3, no. 1 (1993): 57-76; Jacobsen, Cleavage (cit. no. 10); Angell, Science on Trial (cit. no. 24).
64. Wynne, "Misunderstood misunderstanding" (cit. no. 1); S. Epstein, "The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials," Science, Technology and Human Values 20, no. 4 (1995): 408-437; J. Kent and A. Faulkner, "Regulating human implant technologies in Europe-understanding the new era in medical device regulation," Health, Risk & Society 4, no. 2 (2002): 189-209. This last reference gives a fuller account of the evolution of device regulation in Europe and the implications for implant technologies.
65. Wynne, "Misunderstood misunderstanding" (cit. no. 1); S. Epstein, "The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials," Science, Technology and Human Values 20, no. 4 (1995): 408-437; J. Kent and A. Faulkner, "Regulating human implant technologies in Europe-understanding the new era in medical device regulation," Health, Risk & Society 4, no. 2 (2002): 189-209. This last reference gives a fuller account of the evolution of device regulation in Europe and the implications for implant technologies.
66. Wynne, "Misunderstood misunderstanding" (cit. no. 1); S. Epstein, "The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials," Science, Technology and Human Values 20, no. 4 (1995): 408-437; J. Kent and A. Faulkner, "Regulating human implant technologies in Europe-understanding the new era in medical device regulation," Health, Risk & Society 4, no. 2 (2002): 189-209. This last reference gives a fuller account of the evolution of device regulation in Europe and the implications for implant technologies.
67. C. Davison et al., "Lay epidemiology and the prevention paradox," Sociology of Health & Illness 13 (1991): 1-19; G. Williams and J. Popay, "Lay knowledge and the privilege of experience," in Challenging Medicine, eds J. Gabe et al. (London: Routledge, 1995); P. Brown, "Popular epidemiology, toxic waster and social movements," in Medicine, Health and Risk: Sociological Approaches, ed. J. Gabe (Oxford: Blackwells, 1995) 91-112.
68. C. Davison et al., "Lay epidemiology and the prevention paradox," Sociology of Health & Illness 13 (1991): 1-19; G. Williams and J. Popay, "Lay knowledge and the privilege of experience," in Challenging Medicine, eds J. Gabe et al. (London: Routledge, 1995); P. Brown, "Popular epidemiology, toxic waster and social movements," in Medicine, Health and Risk: Sociological Approaches, ed. J. Gabe (Oxford: Blackwells, 1995) 91-112.
69. C. Davison et al., "Lay epidemiology and the prevention paradox," Sociology of Health & Illness 13 (1991): 1-19; G. Williams and J. Popay, "Lay knowledge and the privilege of experience," in Challenging Medicine, eds J. Gabe et al. (London: Routledge, 1995); P. Brown, "Popular epidemiology, toxic waster and social movements," in Medicine, Health and Risk: Sociological Approaches, ed. J. Gabe (Oxford: Blackwells, 1995) 91-112.
70. J. Gabe et al. (eds) Challenging Medicine (London: Routledge, 1995); S. Williams and M. Calnan (eds) Modern Medicine: Lay Perspectives & Experiences (London: University College, 1996).
71. J. Gabe et al. (eds) Challenging Medicine (London: Routledge, 1995); S. Williams and M. Calnan (eds) Modern Medicine: Lay Perspectives & Experiences (London: University College, 1996).
72. S. Carter, "Boundaries of danger and uncertainty: an analysis of the technological culture of risk assessment," in Medicine, Health and Risk: Sociological Approaches, ed. J. Gabe (Oxford: Blackwells, 1995) 133-150.
73. For extensive reviews of the literature, see S. Bondurant et al. (eds) Committee on Safety of Silicons Breast Implants of the Institute of Medicine: Safety of Silicone Breast Implants (Washington: National Academic Press, 1999). Also: Tinkler et al., Medical Devices Evaluation Report, (cit. no. 33); Gott and Tinkler, Silicone Implants and Connective Tissue Disease (cit. no. 33); Independent Review Group, Silicone Gel Breast Implants (cit. no. 34).
74. For extensive reviews of the literature, see S. Bondurant et al. (eds) Committee on Safety of Silicons Breast Implants of the Institute of Medicine: Safety of Silicone Breast Implants (Washington: National Academic Press, 1999). Also: Tinkler et al., Medical Devices Evaluation Report, (cit. no. 33); Gott and Tinkler, Silicone Implants and Connective Tissue Disease (cit. no. 33); Independent Review Group, Silicone Gel Breast Implants (cit. no. 34).
75. For extensive reviews of the literature, see S. Bondurant et al. (eds) Committee on Safety of Silicons Breast Implants of the Institute of Medicine: Safety of Silicone Breast Implants (Washington: National Academic Press, 1999). Also: Tinkler et al., Medical Devices Evaluation Report, (cit. no. 33); Gott and Tinkler, Silicone Implants and Connective Tissue Disease (cit. no. 33); Independent Review Group, Silicone Gel Breast Implants (cit. no. 34).
76. For extensive reviews of the literature, see S. Bondurant et al. (eds) Committee on Safety of Silicons Breast Implants of the Institute of Medicine: Safety of Silicone Breast Implants (Washington: National Academic Press, 1999). Also: Tinkler et al., Medical Devices Evaluation Report, (cit. no. 33); Gott and Tinkler, Silicone Implants and Connective Tissue Disease (cit. no. 33); Independent Review Group, Silicone Gel Breast Implants (cit. no. 34).
77. Jacobsen, Cleavage (cit. no. 10), p. 214.
78. Ibid., p. 8.
79. 93/42/EEC Official Journal L 169, 12.7 (1993).
80. A. Faulkner and J. Kent, "Innovation and regulation of human implant technologies: developing comparative approaches," in Social Science and Medicine 53, (2001): 895-913; Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
81. A. Faulkner and J. Kent, "Innovation and regulation of human implant technologies: developing comparative approaches," in Social Science and Medicine 53, (2001): 895-913; Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
82. J. Martin Moreno et al., Health Risks Posed by Silicone Implants in General, with a Special Attention to Breast Implants: Final Report for EU Scientific and Technological Options Assessment Unit (Brussels: STOA, 2000).
83. Ibid., p. 6.
84. Ibid., p. 9.
85. Ibid., p. 10.
86. Ibid., pp. 17, 38.
87. Communication from the Commission on the Precautionary Principle. European Commission, COM 1, 29 pp. (2001).
88. Report on the Petitions Declared Admissible Concerning Silicone Implants (Petitions 407/98 and 771/98). European Parliament, A5-0186/2001. 4RR41066EN.doc (2001).
89. Communication from the Commission on Community and National Measures in Relation to Breast Implants. European Commission, COM 201, 666 final, 16 pp. (2001).
90. "'Victory' for breast implant victims," BBC News (Thursday 15 November 2001) (http://news.bbc.co.Uk/1/hi/health/1657856.stm).
91. White Stewart, Silicone Spills (cit. no. 10), p. 192.
92. Hazard Notice H2000(05). Medical Devices Agency (2000) (http://www.medical-devices.gov.uk); A. Austin, "Adverse incident reporting to the Medical Devices Agency - a review of reports involving Trilucent breast implants," British Journal of Plastic Surgery 53, (2000): 313-316; Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
93. Hazard Notice H2000(05). Medical Devices Agency (2000) (http://www.medical-devices.gov.uk); A. Austin, "Adverse incident reporting to the Medical Devices Agency - a review of reports involving Trilucent breast implants," British Journal of Plastic Surgery 53, (2000): 313-316; Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
94. Hazard Notice H2000(05). Medical Devices Agency (2000) (http://www.medical-devices.gov.uk); A. Austin, "Adverse incident reporting to the Medical Devices Agency - a review of reports involving Trilucent breast implants," British Journal of Plastic Surgery 53, (2000): 313-316; Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
95. V. Young et al., "Bleed of and biologic response to Triglyceride filler used in radiolucent breast implants," Plastic Reconstructive Surgery 97, (1996): 1170-1193; P. Opitz, and L. Young, "Experience with soybean oil-filled breast implants in Swedish surgical practice," Aesthetic Surgery 18, (1998): 183-197; P. Opitz, personal communication (2001).
96. V. Young et al., "Bleed of and biologic response to Triglyceride filler used in radiolucent breast implants," Plastic Reconstructive Surgery 97, (1996): 1170-1193; P. Opitz, and L. Young, "Experience with soybean oil-filled breast implants in Swedish surgical practice," Aesthetic Surgery 18, (1998): 183-197; P. Opitz, personal communication (2001).
97. V. Young et al., "Bleed of and biologic response to Triglyceride filler used in radiolucent breast implants," Plastic Reconstructive Surgery 97, (1996): 1170-1193; P. Opitz, and L. Young, "Experience with soybean oil-filled breast implants in Swedish surgical practice," Aesthetic Surgery 18, (1998): 183-197; P. Opitz, personal communication (2001).
98. Device Update: Breast Implants. Medical Devices Agency (May 2002) (http:www.medical-devices.gov.uk).
99. D. Hinchliffe, House of Commons Health Committee Fourth Report on the Provision of Information by the Government Relating to the Safety of Breast Implants (London: Stationery Office, 2001) (http://www.publications.parliament.uk).
100. Ibid., p. 1.
101. Independent Review Group, Silicone Gel Breast Implants (cit. no. 34).
102. Hinchliffe, House of Commons Health Committee Fourth Report, para. 21.
103. Ibid., para. 28.
104. Breast implants: Information for Women Considering Breast Implants (London: Department of Health, 2000) (revised version available at http://doh.gov.uk/bimplants/index.htm).
105. Hinchliffe, House of Commons Health Committee Fourth Report, para. 59; Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
106. Hinchliffe, House of Commons Health Committee Fourth Report, para. 59; Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
107. Department of Health, Government Response to the Health Committee's Fourth Report on the Provision of Information by the Government Relating to Safety of Breast Implants (London: The Stationery Office, 2001). This review has now been carried out (see http://www.medical-devices.gov.uk).
108. Kent and Faulkner, "Regulating human implant technologies in Europe" (cit. no. 40).
109. National Breast Implant Registry, Annual Report. Odstock Hospital, Salisbury, UK (2001).
110. A. Irwin, Citizen Science (cit. no. 1); A. Shaw, "It just goes against the grain: lay understandings of genetically-modified (GM) food," Public Understanding of Science (11[3] 273-292, 2002); House of Lords, Science & Technology Committee Third Report on Science and Society (London: The Stationery Office, 2000) (http://www.publications.parliament.uk).
111. A. Irwin, Citizen Science (cit. no. 1); A. Shaw, "It just goes against the grain: lay understandings of genetically-modified (GM) food," Public Understanding of Science (11[3] 273-292, 2002); House of Lords, Science & Technology Committee Third Report on Science and Society (London: The Stationery Office, 2000) (http://www.publications.parliament.uk).
112. A. Irwin, Citizen Science (cit. no. 1); A. Shaw, "It just goes against the grain: lay understandings of genetically-modified (GM) food," Public Understanding of Science (11[3] 273-292, 2002); House of Lords, Science & Technology Committee Third Report on Science and Society (London: The Stationery Office, 2000) (http://www.publications.parliament.uk).
113. A. Irwin, "Constructing the scientific citizen: science and democracy in the biosciences," Public Understanding of Science 10 (2001): 1-18.
114. S. Yearley, "Making systematic sense of public discontents with expert knowledge: two analytical approaches and a case study," Public Understanding of Science 9, (2000): 105-122.
115. Office of Science and Technology, A Consultation Document on a Code of Practice for Scientific Advisory Committees (London: Department of Trade and Industry, 2000) (http://www.dti.gov.uk/publications); P. James et al., A European Food and Public Health Authority: the Future of Scientific Advice in the EU, (Brussels: European Commission, 1999).
116. Office of Science and Technology, A Consultation Document on a Code of Practice for Scientific Advisory Committees (London: Department of Trade and Industry, 2000) (http://www.dti.gov.uk/publications); P. James et al., A European Food and Public Health Authority: the Future of Scientific Advice in the EU, (Brussels: European Commission, 1999).
117. See the minutes of evidence to the Hinchliffe inquiry (cit. no. 62) from Paul Balen, Freethcartwright Solicitors, outlining the difficulties of obtaining compensation and the settlement scheme set up by the manufacturers AEI (Memorandum B15).
118. C. Dyer, "Drug firm faces £10m claim over pill," The Guardian (5 March 2002): 3.
119. B. Salter and L. Frewer, The Changing Governance of Biotechnology: the Politics of Public Trust (Norwich: University of East Anglia, 2000).