Palavras-chave
Doença do silicone mamário
Silicone mamário
Silicone
Silicone mamário
Silicone
Como Citar
Guidugli dos Santos, M. A., Bueno Garcia, E. ., Amarante, J. M. ., & Francescato Veiga, D. . (2020). Controvérsia sobre a Doença do Implante de Silicone Mamário: Uma revisão sistemática sobre o tema. Brazilian Journal of Implantology and Health Sciences, 2(2), 13–31. https://doi.org/10.36557/2674-8169.2020v2n2p13-31
Resumo
Introdução: Atualmente, existem evidências esmagadoras para apoiar a segurança dos implantes mamários de silicone. A decisão obter, manter ou remover os implantes mamários é escolha da paciente. Se uma paciente optar por remover os implantes mamários, é importante encontrar um cirurgião plástico certificado pela Sociedade Brasileira de Cirurgia Plástica.
Objetivos: O objetivo deste artigo é apresentar o estado atual das evidências científicas relacionadas à segurança dos implantes mamários de silicone. Os estudos em andamento são fortemente incentivados em todas as áreas, da detecção do câncer à doença auto-imune, cabendo ao profissional cirurgião plástico (a), o esforço necessário para melhorar a segurança, a conscientização e a educação do paciente.
Metodologia: Foi pesquisado o termo “Silicone Implant Illness” nos portais de indexação Google Acadêmico, Scopus e Web of Sciences e foram selecionados 102 artigos com maior fator de impacto e citações.
Conclusão: Até o presente momento, não existem estudos concretos ou baseados em evidências ou dados revisados por pares sobre a formação de uma nova síndrome.
Referências
1. Statistics from the National Plastic Surgery Data Bank. Aesthetic Surg J. 2017; 37 (Suppl 2): 1–29.
2. Calobrace MB, Capizzi PJ. The biology and evolution of cohesive gel and modeled implants. Plast Reconstr Surg. 2014; 134 (Suppl): 6S-11S.
3. Maxwell GP, Gabriel A. Breast implant design. Gland Surg. 2017; 6: 148–153.
4. US Food and Drug Administration; Center for Devices and Radiological Health. FDA update on the safety of breast implants filled with silicone gel. Available at: https://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm260090.pdf. Accessed December 15, 2018.
5. Nanayakkara PW, by Blok CJ. Silicone gel breast implants: what we know about safety after all these years. Ann Intern Med. 2016; 164: 199–200.
6. Stevens GT, Calobrace MB, Alizadeh K, Zeidler KR, Harrington JL, d'Incelli RC. Ten-year data on the study of round and molded breast implants, approved by the Food and Drug Administration of Sientra, with cohesive silicone gel. Plast Reconstr Surg. 2018; 141 (Round and Sientra XXX cohesive gel implants): 7S - 19S.
7. Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor Contour Profile gel implants: clinical results at age 10. Plast Reconstr Surg. 2017; 140: 1142-1150.
8. Spear SL, Murphy DK; Clinical Study Group of the Allergan silicone breast implant from the USA. Natrelle silicone round breast implants: main results of the study at age 10. Plast Reconstr Surg. 2014; 133: 1354–1361.
9. Stevens WG, Harrington J, Alizadeh K, Broadway D, Zeidler K, Godinez TB. Eight-year follow-up data from the clinical trial in the USA for round and molded implants approved by Sientra's Fient with high strength cohesive silicone gel. Aesthet Surg J. 2015; 35 (Suppl 1): S3-10.
10. Cunningham B, McCue J. Safety and effectiveness of Mentor MemoryGel implants at age 6. Surg Plast Surg. 2009; 33: 440–444.
11. Maxwell GP, Gabriel A. The evolution of breast implants. Plast Reconstr Surg. 2014; 134 (Suppl): 12S - 17S.
12. Coroneos CJ, Selber JC, Offodile AC II, Butler CE, Clemens MW. Post-approval studies of FDA breast implants in the USA: long-term results in 99,993 patients. Ann Surg. 2019; 269: 30–36.
13. McLaughlin JK, Lipworth L, Murphy DK, Walker PS. The safety of breast implants filled with silicone gel: a review of epidemiological evidence. Ann Plast Surg. 2007; 59: 569-580.
14. Beirado FF III, Rohrich RJ, Sykes JM. Taking evidence-based plastic surgery to the next level: Report from the second summit on evidence-based plastic surgery. JAMA Facial Plast Surg. 2013; 15: 314-320.
15. Thoma A, Kaur MN, Hong CJ, Li YK. Methodological guide for the adoption of new aesthetic surgical innovations. Aesthet Surg J. 2015; 35: 308–318.
16. Duvic M, Moore D, Menter A, Vonderheid EC. Cutaneous T-cell lymphoma associated with silicone breast implants. J Am Acad Dermatol. 1995; 32: 939–942.
17. Gidengil CA, Predmore Z, Mattke S, van Busum K, Kim B. Anaplastic large cell lymphoma associated with breast implantation: A systematic review. Plast Reconstr Surg. 2015; 135: 713–720.
18. Breiting VB, Hölmich LR, Brandt B and others. Long-term health status of Danish women with silicone breast implants. Plast Reconstr Surg. 2004; 114: 217–226; discussion 227–228.
19. Brinton LA, Malone KE, Coates RJ, et al. Breast enlargement and reduction: results of a breast cancer case-control study. Plast Reconstr Surg. 1996; 97: 269-275.
20. Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN. Breast cancer after breast augmentation (United States). Cancer Causes Control 2000; 11: 819–827.
21. Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN. Risk of cancer in places other than the breast after breast augmentation. Ann Epidemiol. 2001; 11: 248–256.
22. Bryant H, Brasher P. Breast implants and breast cancer: Reanalysis of a linkage study. N Engl J Med. 1995; 332: 1535-1539.
23. Deapen DM, Bernstein L., Brody GS. Are breast implants anticarcinogenic? A 14-year follow-up from the Los Angeles Study. Plast Reconstr Surg. 1997; 99: 1346–1353.
24. Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton LJ III. Risk of connective tissue diseases and other disorders after breast implantation. N Engl J Med. 1994; 330: 1697-1702.
25. Kern KA, Flannery JT, Kuehn PG. Carcinogenic potential of silicone breast implants: a state study in Connecticut. Plast Reconstr Surg. 1997; 100: 737-747; discussion 748-749.
26. Fonseca, Cristiane Costa, et al. "Breast hypertrophy, reduction mammaplasty, and body image." Aesthetic surgery journal 38.9 (2018): 972-979.
27. Friis S., Hölmich LM, McLaughlin JK, et al. Cancer risk among Danish women with cosmetic breast implants. Int J Cancer 2006; 118: 998–1003.
28. Pukkala E, Boice JD, Hovi SL, et al. Incidence of breast cancer and other cancers among Finnish women with cosmetic breast implants, 1970–1999. J Long Term Eff Med Implants 2002; 12: 271–279.
29. McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nyren O. Long-term cancer risk among Swedish women with cosmetic breast implants: an update from a national study. J Natl Cancer Inst. 2006; 98: 557-560.
30. Brisson J., Holowaty EJ, Villeneuve PJ, et al. Incidence of cancer in a cohort of women from Ontario and Quebec with bilateral breast augmentation. Int J Cancer 2006; 118: 2854–2862.
31. Balk EM, Raman G. Long-term health outcomes in women with silicone gel breast implants. Ann Intern Med. 2016; 165: 527-528.
32. Malone KE, Stanford JL, Daling JR, Voigt LF. Implants and breast cancer. Lancet 1992; 339: 1365.
33. Park AJ, RJ black, Sarhadi NS, Chetty U, Watson AC. Breast implants filled with silicone gel and connective tissue diseases. Plast Reconstr Surg. 1998; 101: 261–268.
34. McLaughlin JK, Nyrén O, Blot WJ, et al. Cancer risk among women with cosmetic breast implants: a population-based cohort study in Sweden. J Natl Cancer Inst. 1998; 90: 156-158.
35. European Committee for Quality Assurance and Medical Devices in Plastic Surgery. Consensus statement on breast implants 23-6-2000. April 16, 2000. Article presented at: European Committee on Quality Assurance (EQUAM). Tel-Aviv, Israel: 4th Consensus Statement.
36. International Cancer Research Agency Working Group for Assessment of Carcinogenic Risks in Humans. Surgical implants and other foreign bodies, nº 74. 1999.Lyon, France; International Cancer Research Agency.
37. National Institutes of Health. Breast implants: Research status at the National Institutes of Health. 2005Bethesda, Md: National Institutes of Health; . Available at: https://permanent.access.gpo.gov/lps87130/rev305BreastImplantsReport.pdf. Accessed December 12, 2018.
38. Lipworth L, Tarone RE, Friis S, et al. Cancer among Scandinavian women with cosmetic breast implants: a joint long-term follow-up study. Int J Cancer 2009; 124: 490–493.
39. Noels EC, Lapid O, Lindeman JH, Bastiaannet E. Breast implants and the risk of breast cancer: A meta-analysis of cohort studies. Aesthet Surg J. 2015; 35: 55–62.
40. Deapen D. Breast implants and breast cancer: A review of incidence, detection, mortality and survival. Plast Reconstr Surg. 2007; 120 (Suppl 1): 70S-80S.
41. Ferreira Amorim, Renata Bites, et al. "Effectiveness of the Brazilian Public Health Policy for Mammographic Screening After the Age of 50 Years." JOURNAL OF WOMENS HEALTH. Vol. 28. No. 6. 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA: MARY ANN LIEBERT, INC, 2019.
42. Deapen DM, Hirsch EM, Brody GS. Cancer risk among Los Angeles women with cosmetic breast implants. Plast Reconstr Surg. 2007; 119: 1987–1992.
43. Brinton LA. The list of silicone breast implants and cancer in other locations. Plast Reconstr Surg. 2007; 120 (Suppl 1): 94S-102S.
44. Kjøller K, Hölmich LR, Fryzek JP, et al. Characteristics of women with cosmetic breast implants compared to women with other types of cosmetic surgery and population-based controls in Denmark. Ann Plast Surg. 2003; 50: 6–12.
45. Cook LS, Daling JR, Voigt LF, et al. Characteristics of women with and without breast augmentation. JAMA 1997; 277: 1612-1617.
46. Brinton LA, Brown SL, Colton T, Burich MC, Lubin J. Characteristics of a population of women with breast implants compared to women seeking other types of plastic surgery. Plast Reconstr Surg. 2000; 105: 919–927; discussion 928–929.
47. Fryzek JP, Weiderpass E, Signorello LB, et al. Characteristics of women with breast augmentation plastic surgery compared to breast reduction surgery patients and women in the general population of Sweden. Ann Plast Surg. 2000; 45: 349–356.
48. McLaughlin JK, Lipworth L. Brain cancer and cosmetic breast implants: A review of epidemiological evidence. Ann Plast Surg. 2004; 52: 115-117.
49. Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN. Mortality rates in patients with breast augmentation: an update. Epidemiology 2006; 17: 162–169.
50. Jacobsen PH, Hölmich LR, McLaughlin JK, et al. Mortality and suicide among Danish women with cosmetic breast implants. Arch Intern Med. 2004; 164: 2450-2455.
51. Villeneuve PJ, Holowaty EJ, Brisson J, et al. Mortality among Canadian women with cosmetic breast implants. Am J Epidemiol. 2006; 164: 334–341.
52. Singh N, Picha GJ, Hardas B, Schumacher A, Murphy DK. Five-year safety data for more than 55,000 patients after breast implantation: Comparison of rare adverse event rates with silicone implants versus national standards and saline implants. Plast Reconstr Surg. 2017; 140: 666–679.
53. Leberfinger AN, Behar BJ, Williams NC, et al. Anaplastic large cell lymphoma associated with breast implantation: a systematic review. JAMA Surg. 2017; 152: 1161-1168.
54. Rupani A, Frame JD, Kamel D. Lymphomas associated with breast implants: A literature review. Aesthet Surg J. 2015; 35: 533-544.
55. Keech JA Jr, Creech BJ. Anaplastic T-cell lymphoma near a breast implant filled with saline. Plast Reconstr Surg. 1997; 100: 554-555.
56. Brody GS. Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg. 2015; 136: 553e-554e.
57. Srinivasa DR, Miranda RN, Kaura A, et al. Global adverse event reports from ALCL associated with breast implants: an international review of 40 databases of government officials. Plast Reconstr Surg. 2017; 139: 1029-1039.
58. US Food and Drug Administration. Anaplastic large cell lymphoma associated with breast implant (BIA-ALCL). Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm. Accessed August 26, 2018.
59. Correia-Sá, Inês, et al. "Predictors of satisfaction in patient with silicone breast implants and its association with drug intake habits." Acta Chirurgica Belgica 117.2 (2017): 89-98.
60. Largent J, Oefelein M, Kaplan HM, Okerson T, Boyle P. Risk of lymphoma in women with breast implants: Analysis of clinical studies. Eur J Cancer Prev. 2012; 21: 274-280.
61. Lazzeri D., Agostini T., Giannotti G. et al. Anaplastic lymphoma of the null type Anaplastic lymphoma of large cells, kinase-negative, appearing in a silicone breast implant capsule. Plast Reconstr Surg. 2011; 127: 159e to 162e.
62. Deva AK. Discussion: North American epidemiology of anaplastic large cell lymphoma associated with breast implantation. Plast Reconstr Surg. 2017; 139: 1051-1052.
63. Lipworth L., Tarone RE, McLaughlin JK. Silicone breast implants and connective tissue disease: an updated review of epidemiological evidence. Ann Plast Surg. 2004; 52: 598–601.
64. Blackburn WD Jr., Everson MP. Silicone-associated rheumatic disease: an unsupported myth. Plast Reconstr Surg. 1997; 99: 1362–1367.
65. Downing D. Silicone gel breast implants: UK Independent Review Group report. J Nutr Environ Med. 1998.
66. Janowsky EC, Kupper LL, Hulka BS. Meta-analyzes of the relationship between silicone breast implants and the risk of connective tissue diseases. N Engl J Med. 2000; 342: 781–790.
67. Lamm SH. Silicone breast implants, breast cancer and specific connective tissue diseases: a systematic review of data in the epidemiological literature. Int J Toxicol. 1998; 17: 497-527.
68. Silverman BG, Brown SL, Bright RA, Kaczmarek RG, Arrowsmith-Lowe JB, Kessler DA. Reported complications of silicone gel breast implants: an epidemiological review. Ann Intern Med. 1996; 124: 744-756.
69. Tugwell P, Wells G., Peterson J. et al. Do silicone breast implants cause rheumatological disorders? A systematic review for a national science panel appointed by the court. Rheum arthritis. 2001; 44: 2477-2484.
70. Wong O. A critical assessment of the relationship between silicone breast implants and connective tissue diseases. Regul Toxicol Pharmacol. 1996; 23: 74–85.
71. Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective tissue diseases in healthcare professionals: a retrospective cohort study. JAMA 1996; 275: 616–621.
72. Karlson EW, Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Comparison of self-reported diagnosis of connective tissue disease with medical records in female health professionals: The Women's Health Cohort Study. Am J Epidemiol. 1999; 150: 652-660.
73. Brinton LA, Buckley LM, Dvorkina O, et al. Risk of connective tissue disorders in patients with breast implants. Am J Epidemiol. 2004; 160: 619–627.
74. Fryzek JP, Holmich L., McLaughlin JK, et al. A national study of connective tissue diseases and other rheumatic conditions among Danish women with long-term aesthetic breast implantation. Ann Epidemiol. 2007; 17: 374–379.
75. Hölmich LR, Kjøller K, Fryzek JP, et al. Self-reported diseases and symptoms due to rupture status among unselected Danish women with silicone silicone implants. Plast Reconstr Surg. 2003; 111: 723-732; discussion 733-734.
76. Hölmich LR, Lipworth L, McLaughlin JK, Friis S. Breast implant rupture and connective tissue disease: A literature review. Plast Reconstr Surg. 2007; 120 (Suppl 1): 62S-69S.
77. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Rupture of silicone gel breast implant, extracapsular silicone and health status in a population of women. J. Rheumatol. 2001; 28: 996–1003.
78. Lipworth L, Holmich LR, McLaughlin JK. Silicone breast implants and connective tissue disease: No association. Semin Immunopathol. 2011; 33: 287–294.
79. Diamond B, Hulka BS, Kerkvliet N, Tugwell P. Silicone breast implants for connective tissue diseases and immune dysfunction: a report by a national science panel to the honorable coordinator Sam C. Pointer Jr. of the federal judge of breast implants Multi-district litigation. Fed J Sci. 1998.
80. Watad A, Rosenberg V, Tiosano S, et al. Silicone breast implants and risk of autoimmune / rheumatic diseases: a real-world analysis. Int J Epidemiol. 2018; 47: 1846-1854.
81. Colwell AS, Mehrara B. Editorial: Post-approval studies of US FDA breast implants: long-term results in 99,993 patients. Ann Surg. 2019; 269: 39–40.
82. Ashar B. Statement by Binita Ashar, MD, from the FDA Center for Devices and Radiological Health, on the agency's commitment to studying the safety of breast implants. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620589.htm?utm_campaign=09142018_Statement_FDA+Statement+on+agency's+commitment+to+studying+breast+implant+safety&utm93208A05&downloads. Accessed November 18, 2018.
83. Lipworth L., Nyren O, Y W, Fryzek JP, Tarone RE, McLaughlin JK. Excessive suicide mortality and other external causes of death among women with cosmetic breast implants. Ann Plast Surg. 2007; 59: 119–123; discussion 124-125.
84. Brinton LA, Lubin JH, Burich MC, Colton T, Hoover RN. Mortality in patients with breast augmentation. Epidemiology 2001; 12: 321–326.
85. Pukkala E, Kulmala I, Hovi SL, et al. Causes of death among Finnish women with cosmetic breast implants, 1971–2001. Ann Plast Surg. 2003; 51: 339–342; discussion 343-344.
86. McLaughlin JK, Lipworth L., Tarone RE. Suicide among women with cosmetic breast implants: a review of epidemiological evidence. J Long Term Eff Med Implants 2003; 13: 445–450.
87. Neto, Miguel Sabino, et al. "Quality of life and self-esteem after breast asymmetry surgery." Aesthetic surgery journal 27.6 (2007): 616-621.
88. Winther JF, Bach FW, Friis S, et al. Neurological disease in women with breast implants. Neurology 1998; 50: 951–955.
89. Winther JF, Friis S, Bach FW, et al. Neurological disease among women with silicone breast implants in Denmark. Acta Neurol Scand. 2001; 103: 93–96.
90. Ferguson JH. Silicone breast implants and neurological disorders: Report from the American Academy of Neurology Practice Committee. Neurology 1997; 48: 1504–1507.
91. Levine JJ, Ilowite NT. Esophageal disease similar to scleroderma in children breastfed by mothers with silicone breast implants. JAMA 1994; 271: 213-216.
92. Levine JJ, Trachtman H, Gold DM, Pettei MJ. Esophageal dysmotility in children breastfed by mothers with silicone breast implants: long-term follow-up and response to treatment. Dig Dis Sci. 1996; 41: 1600–1603.
93. Levine JJ, Lin HC, Rowley M, Cook A, Teuber SS, Ilowite NT. Lack of expression of autoantibodies in children born to mothers with silicone breast implants. Pediatrics 1996; 97: 243-245.
94. Teuber SS, Gershwin ME. Autoantibodies and clinical rheumatic complaints in two children of women with silicone gel breast implants. Int Arch Allergy Immunol. 1994; 103: 105-108.
95. Levine JJ, Ilowite NT, Pettei MJ, Trachtman H. Increased urinary excretion of NO3 (-) + NO2- and neopterin in children breastfed by mothers with silicone breast implants: Evidence for macrophage activation. J. Rheumatol. 1996; 23: 1083-1087.
96. Gedalia A, Cuellar M, Espinoza L. Skin rash and anti-Ro / SS-A antibodies in a mother's baby with silicone breast implants. Clin Exp Rheumatol. 1995; 17: 374-370.
97. Bastos, Erika M., et al. "Histologic analysis of zafirlukast’s effect on capsule formation around silicone implants." Aesthetic plastic surgery 31.5 (2007): 559-565.
98. Kjøller K, Friis S, Signorello LB, et al. Health outcomes in children of Danish mothers with cosmetic breast implants. Ann Plast Surg. 2002; 48: 238-245.
99. Signorello LB, Fryzek JP, Blot WJ, McLaughlin JK, Nyrén O. Health risk to children after cosmetic breast implant in Sweden. Ann Plast Surg. 2001; 46: 279–286.
100. Hemminki E, Hovi SL, Sevón T, Asko-Seljavaara S. Births and perinatal health of babies among women who had a silicone breast implant in Finland, 1967–2000. Acta Obstet Gynecol Scand. 2004; 83: 1135-1140.
101. Jewell M, Edwards MC, Murphy DK, Schumacher A. Lactation results in over 3,500 women after primary augmentation: 5-year data from the follow-up breast implant study. Aesthetic Surg J.E- published before printing on August 27, 2018. doi: 10.1093 / asj / sjy221.
102. Clemens MW, Brody GS, Mahabir RC, Miranda RN. How to diagnose and treat anaplastic large cell lymphoma associated with breast implantation. Plast Reconstr Surg. 2018; 141: 586e-599e.
2. Calobrace MB, Capizzi PJ. The biology and evolution of cohesive gel and modeled implants. Plast Reconstr Surg. 2014; 134 (Suppl): 6S-11S.
3. Maxwell GP, Gabriel A. Breast implant design. Gland Surg. 2017; 6: 148–153.
4. US Food and Drug Administration; Center for Devices and Radiological Health. FDA update on the safety of breast implants filled with silicone gel. Available at: https://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm260090.pdf. Accessed December 15, 2018.
5. Nanayakkara PW, by Blok CJ. Silicone gel breast implants: what we know about safety after all these years. Ann Intern Med. 2016; 164: 199–200.
6. Stevens GT, Calobrace MB, Alizadeh K, Zeidler KR, Harrington JL, d'Incelli RC. Ten-year data on the study of round and molded breast implants, approved by the Food and Drug Administration of Sientra, with cohesive silicone gel. Plast Reconstr Surg. 2018; 141 (Round and Sientra XXX cohesive gel implants): 7S - 19S.
7. Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor Contour Profile gel implants: clinical results at age 10. Plast Reconstr Surg. 2017; 140: 1142-1150.
8. Spear SL, Murphy DK; Clinical Study Group of the Allergan silicone breast implant from the USA. Natrelle silicone round breast implants: main results of the study at age 10. Plast Reconstr Surg. 2014; 133: 1354–1361.
9. Stevens WG, Harrington J, Alizadeh K, Broadway D, Zeidler K, Godinez TB. Eight-year follow-up data from the clinical trial in the USA for round and molded implants approved by Sientra's Fient with high strength cohesive silicone gel. Aesthet Surg J. 2015; 35 (Suppl 1): S3-10.
10. Cunningham B, McCue J. Safety and effectiveness of Mentor MemoryGel implants at age 6. Surg Plast Surg. 2009; 33: 440–444.
11. Maxwell GP, Gabriel A. The evolution of breast implants. Plast Reconstr Surg. 2014; 134 (Suppl): 12S - 17S.
12. Coroneos CJ, Selber JC, Offodile AC II, Butler CE, Clemens MW. Post-approval studies of FDA breast implants in the USA: long-term results in 99,993 patients. Ann Surg. 2019; 269: 30–36.
13. McLaughlin JK, Lipworth L, Murphy DK, Walker PS. The safety of breast implants filled with silicone gel: a review of epidemiological evidence. Ann Plast Surg. 2007; 59: 569-580.
14. Beirado FF III, Rohrich RJ, Sykes JM. Taking evidence-based plastic surgery to the next level: Report from the second summit on evidence-based plastic surgery. JAMA Facial Plast Surg. 2013; 15: 314-320.
15. Thoma A, Kaur MN, Hong CJ, Li YK. Methodological guide for the adoption of new aesthetic surgical innovations. Aesthet Surg J. 2015; 35: 308–318.
16. Duvic M, Moore D, Menter A, Vonderheid EC. Cutaneous T-cell lymphoma associated with silicone breast implants. J Am Acad Dermatol. 1995; 32: 939–942.
17. Gidengil CA, Predmore Z, Mattke S, van Busum K, Kim B. Anaplastic large cell lymphoma associated with breast implantation: A systematic review. Plast Reconstr Surg. 2015; 135: 713–720.
18. Breiting VB, Hölmich LR, Brandt B and others. Long-term health status of Danish women with silicone breast implants. Plast Reconstr Surg. 2004; 114: 217–226; discussion 227–228.
19. Brinton LA, Malone KE, Coates RJ, et al. Breast enlargement and reduction: results of a breast cancer case-control study. Plast Reconstr Surg. 1996; 97: 269-275.
20. Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN. Breast cancer after breast augmentation (United States). Cancer Causes Control 2000; 11: 819–827.
21. Brinton LA, Lubin JH, Burich MC, Colton T, Brown SL, Hoover RN. Risk of cancer in places other than the breast after breast augmentation. Ann Epidemiol. 2001; 11: 248–256.
22. Bryant H, Brasher P. Breast implants and breast cancer: Reanalysis of a linkage study. N Engl J Med. 1995; 332: 1535-1539.
23. Deapen DM, Bernstein L., Brody GS. Are breast implants anticarcinogenic? A 14-year follow-up from the Los Angeles Study. Plast Reconstr Surg. 1997; 99: 1346–1353.
24. Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton LJ III. Risk of connective tissue diseases and other disorders after breast implantation. N Engl J Med. 1994; 330: 1697-1702.
25. Kern KA, Flannery JT, Kuehn PG. Carcinogenic potential of silicone breast implants: a state study in Connecticut. Plast Reconstr Surg. 1997; 100: 737-747; discussion 748-749.
26. Fonseca, Cristiane Costa, et al. "Breast hypertrophy, reduction mammaplasty, and body image." Aesthetic surgery journal 38.9 (2018): 972-979.
27. Friis S., Hölmich LM, McLaughlin JK, et al. Cancer risk among Danish women with cosmetic breast implants. Int J Cancer 2006; 118: 998–1003.
28. Pukkala E, Boice JD, Hovi SL, et al. Incidence of breast cancer and other cancers among Finnish women with cosmetic breast implants, 1970–1999. J Long Term Eff Med Implants 2002; 12: 271–279.
29. McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nyren O. Long-term cancer risk among Swedish women with cosmetic breast implants: an update from a national study. J Natl Cancer Inst. 2006; 98: 557-560.
30. Brisson J., Holowaty EJ, Villeneuve PJ, et al. Incidence of cancer in a cohort of women from Ontario and Quebec with bilateral breast augmentation. Int J Cancer 2006; 118: 2854–2862.
31. Balk EM, Raman G. Long-term health outcomes in women with silicone gel breast implants. Ann Intern Med. 2016; 165: 527-528.
32. Malone KE, Stanford JL, Daling JR, Voigt LF. Implants and breast cancer. Lancet 1992; 339: 1365.
33. Park AJ, RJ black, Sarhadi NS, Chetty U, Watson AC. Breast implants filled with silicone gel and connective tissue diseases. Plast Reconstr Surg. 1998; 101: 261–268.
34. McLaughlin JK, Nyrén O, Blot WJ, et al. Cancer risk among women with cosmetic breast implants: a population-based cohort study in Sweden. J Natl Cancer Inst. 1998; 90: 156-158.
35. European Committee for Quality Assurance and Medical Devices in Plastic Surgery. Consensus statement on breast implants 23-6-2000. April 16, 2000. Article presented at: European Committee on Quality Assurance (EQUAM). Tel-Aviv, Israel: 4th Consensus Statement.
36. International Cancer Research Agency Working Group for Assessment of Carcinogenic Risks in Humans. Surgical implants and other foreign bodies, nº 74. 1999.Lyon, France; International Cancer Research Agency.
37. National Institutes of Health. Breast implants: Research status at the National Institutes of Health. 2005Bethesda, Md: National Institutes of Health; . Available at: https://permanent.access.gpo.gov/lps87130/rev305BreastImplantsReport.pdf. Accessed December 12, 2018.
38. Lipworth L, Tarone RE, Friis S, et al. Cancer among Scandinavian women with cosmetic breast implants: a joint long-term follow-up study. Int J Cancer 2009; 124: 490–493.
39. Noels EC, Lapid O, Lindeman JH, Bastiaannet E. Breast implants and the risk of breast cancer: A meta-analysis of cohort studies. Aesthet Surg J. 2015; 35: 55–62.
40. Deapen D. Breast implants and breast cancer: A review of incidence, detection, mortality and survival. Plast Reconstr Surg. 2007; 120 (Suppl 1): 70S-80S.
41. Ferreira Amorim, Renata Bites, et al. "Effectiveness of the Brazilian Public Health Policy for Mammographic Screening After the Age of 50 Years." JOURNAL OF WOMENS HEALTH. Vol. 28. No. 6. 140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801 USA: MARY ANN LIEBERT, INC, 2019.
42. Deapen DM, Hirsch EM, Brody GS. Cancer risk among Los Angeles women with cosmetic breast implants. Plast Reconstr Surg. 2007; 119: 1987–1992.
43. Brinton LA. The list of silicone breast implants and cancer in other locations. Plast Reconstr Surg. 2007; 120 (Suppl 1): 94S-102S.
44. Kjøller K, Hölmich LR, Fryzek JP, et al. Characteristics of women with cosmetic breast implants compared to women with other types of cosmetic surgery and population-based controls in Denmark. Ann Plast Surg. 2003; 50: 6–12.
45. Cook LS, Daling JR, Voigt LF, et al. Characteristics of women with and without breast augmentation. JAMA 1997; 277: 1612-1617.
46. Brinton LA, Brown SL, Colton T, Burich MC, Lubin J. Characteristics of a population of women with breast implants compared to women seeking other types of plastic surgery. Plast Reconstr Surg. 2000; 105: 919–927; discussion 928–929.
47. Fryzek JP, Weiderpass E, Signorello LB, et al. Characteristics of women with breast augmentation plastic surgery compared to breast reduction surgery patients and women in the general population of Sweden. Ann Plast Surg. 2000; 45: 349–356.
48. McLaughlin JK, Lipworth L. Brain cancer and cosmetic breast implants: A review of epidemiological evidence. Ann Plast Surg. 2004; 52: 115-117.
49. Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN. Mortality rates in patients with breast augmentation: an update. Epidemiology 2006; 17: 162–169.
50. Jacobsen PH, Hölmich LR, McLaughlin JK, et al. Mortality and suicide among Danish women with cosmetic breast implants. Arch Intern Med. 2004; 164: 2450-2455.
51. Villeneuve PJ, Holowaty EJ, Brisson J, et al. Mortality among Canadian women with cosmetic breast implants. Am J Epidemiol. 2006; 164: 334–341.
52. Singh N, Picha GJ, Hardas B, Schumacher A, Murphy DK. Five-year safety data for more than 55,000 patients after breast implantation: Comparison of rare adverse event rates with silicone implants versus national standards and saline implants. Plast Reconstr Surg. 2017; 140: 666–679.
53. Leberfinger AN, Behar BJ, Williams NC, et al. Anaplastic large cell lymphoma associated with breast implantation: a systematic review. JAMA Surg. 2017; 152: 1161-1168.
54. Rupani A, Frame JD, Kamel D. Lymphomas associated with breast implants: A literature review. Aesthet Surg J. 2015; 35: 533-544.
55. Keech JA Jr, Creech BJ. Anaplastic T-cell lymphoma near a breast implant filled with saline. Plast Reconstr Surg. 1997; 100: 554-555.
56. Brody GS. Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg. 2015; 136: 553e-554e.
57. Srinivasa DR, Miranda RN, Kaura A, et al. Global adverse event reports from ALCL associated with breast implants: an international review of 40 databases of government officials. Plast Reconstr Surg. 2017; 139: 1029-1039.
58. US Food and Drug Administration. Anaplastic large cell lymphoma associated with breast implant (BIA-ALCL). Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm. Accessed August 26, 2018.
59. Correia-Sá, Inês, et al. "Predictors of satisfaction in patient with silicone breast implants and its association with drug intake habits." Acta Chirurgica Belgica 117.2 (2017): 89-98.
60. Largent J, Oefelein M, Kaplan HM, Okerson T, Boyle P. Risk of lymphoma in women with breast implants: Analysis of clinical studies. Eur J Cancer Prev. 2012; 21: 274-280.
61. Lazzeri D., Agostini T., Giannotti G. et al. Anaplastic lymphoma of the null type Anaplastic lymphoma of large cells, kinase-negative, appearing in a silicone breast implant capsule. Plast Reconstr Surg. 2011; 127: 159e to 162e.
62. Deva AK. Discussion: North American epidemiology of anaplastic large cell lymphoma associated with breast implantation. Plast Reconstr Surg. 2017; 139: 1051-1052.
63. Lipworth L., Tarone RE, McLaughlin JK. Silicone breast implants and connective tissue disease: an updated review of epidemiological evidence. Ann Plast Surg. 2004; 52: 598–601.
64. Blackburn WD Jr., Everson MP. Silicone-associated rheumatic disease: an unsupported myth. Plast Reconstr Surg. 1997; 99: 1362–1367.
65. Downing D. Silicone gel breast implants: UK Independent Review Group report. J Nutr Environ Med. 1998.
66. Janowsky EC, Kupper LL, Hulka BS. Meta-analyzes of the relationship between silicone breast implants and the risk of connective tissue diseases. N Engl J Med. 2000; 342: 781–790.
67. Lamm SH. Silicone breast implants, breast cancer and specific connective tissue diseases: a systematic review of data in the epidemiological literature. Int J Toxicol. 1998; 17: 497-527.
68. Silverman BG, Brown SL, Bright RA, Kaczmarek RG, Arrowsmith-Lowe JB, Kessler DA. Reported complications of silicone gel breast implants: an epidemiological review. Ann Intern Med. 1996; 124: 744-756.
69. Tugwell P, Wells G., Peterson J. et al. Do silicone breast implants cause rheumatological disorders? A systematic review for a national science panel appointed by the court. Rheum arthritis. 2001; 44: 2477-2484.
70. Wong O. A critical assessment of the relationship between silicone breast implants and connective tissue diseases. Regul Toxicol Pharmacol. 1996; 23: 74–85.
71. Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective tissue diseases in healthcare professionals: a retrospective cohort study. JAMA 1996; 275: 616–621.
72. Karlson EW, Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Comparison of self-reported diagnosis of connective tissue disease with medical records in female health professionals: The Women's Health Cohort Study. Am J Epidemiol. 1999; 150: 652-660.
73. Brinton LA, Buckley LM, Dvorkina O, et al. Risk of connective tissue disorders in patients with breast implants. Am J Epidemiol. 2004; 160: 619–627.
74. Fryzek JP, Holmich L., McLaughlin JK, et al. A national study of connective tissue diseases and other rheumatic conditions among Danish women with long-term aesthetic breast implantation. Ann Epidemiol. 2007; 17: 374–379.
75. Hölmich LR, Kjøller K, Fryzek JP, et al. Self-reported diseases and symptoms due to rupture status among unselected Danish women with silicone silicone implants. Plast Reconstr Surg. 2003; 111: 723-732; discussion 733-734.
76. Hölmich LR, Lipworth L, McLaughlin JK, Friis S. Breast implant rupture and connective tissue disease: A literature review. Plast Reconstr Surg. 2007; 120 (Suppl 1): 62S-69S.
77. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Rupture of silicone gel breast implant, extracapsular silicone and health status in a population of women. J. Rheumatol. 2001; 28: 996–1003.
78. Lipworth L, Holmich LR, McLaughlin JK. Silicone breast implants and connective tissue disease: No association. Semin Immunopathol. 2011; 33: 287–294.
79. Diamond B, Hulka BS, Kerkvliet N, Tugwell P. Silicone breast implants for connective tissue diseases and immune dysfunction: a report by a national science panel to the honorable coordinator Sam C. Pointer Jr. of the federal judge of breast implants Multi-district litigation. Fed J Sci. 1998.
80. Watad A, Rosenberg V, Tiosano S, et al. Silicone breast implants and risk of autoimmune / rheumatic diseases: a real-world analysis. Int J Epidemiol. 2018; 47: 1846-1854.
81. Colwell AS, Mehrara B. Editorial: Post-approval studies of US FDA breast implants: long-term results in 99,993 patients. Ann Surg. 2019; 269: 39–40.
82. Ashar B. Statement by Binita Ashar, MD, from the FDA Center for Devices and Radiological Health, on the agency's commitment to studying the safety of breast implants. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620589.htm?utm_campaign=09142018_Statement_FDA+Statement+on+agency's+commitment+to+studying+breast+implant+safety&utm93208A05&downloads. Accessed November 18, 2018.
83. Lipworth L., Nyren O, Y W, Fryzek JP, Tarone RE, McLaughlin JK. Excessive suicide mortality and other external causes of death among women with cosmetic breast implants. Ann Plast Surg. 2007; 59: 119–123; discussion 124-125.
84. Brinton LA, Lubin JH, Burich MC, Colton T, Hoover RN. Mortality in patients with breast augmentation. Epidemiology 2001; 12: 321–326.
85. Pukkala E, Kulmala I, Hovi SL, et al. Causes of death among Finnish women with cosmetic breast implants, 1971–2001. Ann Plast Surg. 2003; 51: 339–342; discussion 343-344.
86. McLaughlin JK, Lipworth L., Tarone RE. Suicide among women with cosmetic breast implants: a review of epidemiological evidence. J Long Term Eff Med Implants 2003; 13: 445–450.
87. Neto, Miguel Sabino, et al. "Quality of life and self-esteem after breast asymmetry surgery." Aesthetic surgery journal 27.6 (2007): 616-621.
88. Winther JF, Bach FW, Friis S, et al. Neurological disease in women with breast implants. Neurology 1998; 50: 951–955.
89. Winther JF, Friis S, Bach FW, et al. Neurological disease among women with silicone breast implants in Denmark. Acta Neurol Scand. 2001; 103: 93–96.
90. Ferguson JH. Silicone breast implants and neurological disorders: Report from the American Academy of Neurology Practice Committee. Neurology 1997; 48: 1504–1507.
91. Levine JJ, Ilowite NT. Esophageal disease similar to scleroderma in children breastfed by mothers with silicone breast implants. JAMA 1994; 271: 213-216.
92. Levine JJ, Trachtman H, Gold DM, Pettei MJ. Esophageal dysmotility in children breastfed by mothers with silicone breast implants: long-term follow-up and response to treatment. Dig Dis Sci. 1996; 41: 1600–1603.
93. Levine JJ, Lin HC, Rowley M, Cook A, Teuber SS, Ilowite NT. Lack of expression of autoantibodies in children born to mothers with silicone breast implants. Pediatrics 1996; 97: 243-245.
94. Teuber SS, Gershwin ME. Autoantibodies and clinical rheumatic complaints in two children of women with silicone gel breast implants. Int Arch Allergy Immunol. 1994; 103: 105-108.
95. Levine JJ, Ilowite NT, Pettei MJ, Trachtman H. Increased urinary excretion of NO3 (-) + NO2- and neopterin in children breastfed by mothers with silicone breast implants: Evidence for macrophage activation. J. Rheumatol. 1996; 23: 1083-1087.
96. Gedalia A, Cuellar M, Espinoza L. Skin rash and anti-Ro / SS-A antibodies in a mother's baby with silicone breast implants. Clin Exp Rheumatol. 1995; 17: 374-370.
97. Bastos, Erika M., et al. "Histologic analysis of zafirlukast’s effect on capsule formation around silicone implants." Aesthetic plastic surgery 31.5 (2007): 559-565.
98. Kjøller K, Friis S, Signorello LB, et al. Health outcomes in children of Danish mothers with cosmetic breast implants. Ann Plast Surg. 2002; 48: 238-245.
99. Signorello LB, Fryzek JP, Blot WJ, McLaughlin JK, Nyrén O. Health risk to children after cosmetic breast implant in Sweden. Ann Plast Surg. 2001; 46: 279–286.
100. Hemminki E, Hovi SL, Sevón T, Asko-Seljavaara S. Births and perinatal health of babies among women who had a silicone breast implant in Finland, 1967–2000. Acta Obstet Gynecol Scand. 2004; 83: 1135-1140.
101. Jewell M, Edwards MC, Murphy DK, Schumacher A. Lactation results in over 3,500 women after primary augmentation: 5-year data from the follow-up breast implant study. Aesthetic Surg J.E- published before printing on August 27, 2018. doi: 10.1093 / asj / sjy221.
102. Clemens MW, Brody GS, Mahabir RC, Miranda RN. How to diagnose and treat anaplastic large cell lymphoma associated with breast implantation. Plast Reconstr Surg. 2018; 141: 586e-599e.
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