Reported complications of silicone gel breast implants: An epidemiologic review

Annals of Internal Medicine

Volumn 124, Issue 8, 1996, Pages 744-756

  Silverman, Barbara G ^a   Brown, S Lori ^a   Bright, Roselie A ^a   Kaczmarek, Ronald G ^a   Arrowsmith Lowe, Janet B ^a,b   Kessler, David A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUTOIMMUNITY; BREAST CANCER; BREAST ENDOPROSTHESIS; COMPLICATION; CONNECTIVE TISSUE DISEASE; EPIDEMIOLOGY; HUMAN; MASTALGIA; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RUPTURE; SCLERODERMA; SILICONE PROSTHESIS;

EID: 0029921807     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-124-8-199604150-00008     Document Type: Review

References (104)

1. Cronin TD, Gerow FJ. Augmentation mammaplasty a new "natural feel" prosthesis. Transactions of the Third International Congress of Plastic Surgery Amsterdam Excerpta Medica Foundation, 1964 41-9.
2. Bridges AJ, Vasey FB. Silicone breast implants History, safety, and potential complications. Arch Intern Med 1993,152:2638-44
3. Sanchez-Guerrero J, Schur PH, Sergent JS, Liang MH. Silicone breast implants and rheumatic disease Clinical, immunologic, and epidemiologic studies Arthritis Rheum 1994,37 158-68.
4. Hochberg MC. Cosmetic surgical procedures and connective tissue disease: the Cleopatra syndrome revisited [Editorial]. Ann Intern Med 1993,118 981-2
5. Kessler DA. The basis of the FDA's decision on breast implants N Engl J Med 1992,326 1713-5
6. Rohrich RJ, Clark CP 3d. Controversy over the silicone gel breast implant current status and clinical implications Tex Med 1993,89 52-8
7. Kessler DA, Merkatz RB, Schapiro R. A call for higher standards for breast implants. JAMA 1993,270 2607-8
8. Yuen JC, Klitzman B, Serafin D. Biomaterials used in plastic surgery In Greco RS Implantation Biology The Host Response and Biomedical Devices Boca Raton, FL CRC Pr; 1994 192-228
9. Bright RA, Jeng LL, Moore RM. National survey of self-reported breast implants 1988 estimates Journal of Long-Term Effects of Medical Implants 1993,3 81-9
10. Theta Corporation. Soft Tissue Implants Market. Theta Market Report No 224 Middlefield, CT, 1991.5
11. Theta Corporation. Soft Tissue Implants Market. Theta Market Report No. 606 Middlefield, CT, 1987:22-34.
12. Cook RR, Delongchamp RR, Woodbury M, Perkins LL, Harrison MC. The prevalence of women with breast implants in the United States - 1989 J Clin Epidemiol 1996,48 519-25
13. Gabriel SE, O'Fallon WM, Beard CM, Kurland LT, Woods JE, Melton LJ 3d. Trends in the utilization of silicone breast implants, 1964-1991, and methodology for a population-based study of outcomes J Clin Epidemiol 1995,48 527-37
14. Terry MB, Skovron ML, Garbers S, Sonnenschein E, Toniolo P. The estimated frequency of cosmetic breast augmentation among U S women, 1963 through 1988 Am J Public Health. 1995,85 1122-4
15. Andersen B, Hawtof D, Alani H, Kapetansky D. The diagnosis of ruptured breast implants Plast Reconstr Surg 1989;84 903-7.
16. de Camara DL, Sheridan JM, Kammer BA. Ruptures and aging of silicone gel breast implants. Plast Reconstr Surg 1993,91 828-34.
17. Peters W, Keystone E, Smith D. Factors affecting the rupture of silicone-gel breast implants Ann Plast Surg 1994,32 449-51.
18. Eisenberg HV, Bartels RJ. Rupture of a silicone bag-gel breast implant by closed compression capsulotomy case report. Plast Reconstr Surg 1977,59 849-50
19. Harris KM, Ganott MA, Shestak KC, Losken HW, Tobon H. Silicone implant rupture: detection with US Radiology 1993,187:761-8.
20. Peters W, Pugash R. Ultrasound analysis of 150 patients with silicone gel breast implants Ann Plast Surg 1993,31 7-9
21. Ahn CY, Shaw WW, Narayanan K, Gorczyca DP, Sinha S, Debruhl ND, et al. Definitive diagnosis of breast implant rupture using magnetic resonance imaging Plast Reconstr Surg. 1993,92 681-91
22. Ahn CY, DeBruhl ND, Gorczyca DP, Shaw WW, Basset LW. Comparative silicone breast implant evaluation using mammography, sonography, and magnetic resonance imaging experience with 59 implants Plast Reconstr Surg. 1994,94.620-7.
23. Destouet JM, Monsees BS, Oser RF, Nemecek JR, Young VL, Pilgram TK. Screening mammography in 350 women with breast implants: prevalence and findings of implant complications AJR Am J Roentgenol 1992; 159 973-8
24. Robinson OG Jr, Bradley EL, Wilson DS. Analysis of explanted silicone implants, a report of 300 patients Ann Plast Surg. 1995;34-1-7.
25. van Rappard JH, Sonneveld GJ, van Twisk R, Borghouts JM. Pressure resistance of breast implants as a function of implantation time. Ann Plast Surg 1988,21 566-9
26. Barker DE, Retsky MI, Schultz S. Bleeding of silicone from bag-gel breast implants, and its clinical relation to fibrous capsule reaction Plast Reconstr Surg 1978,61 836-41
27. Copeland M, Choi M, Bleiweiss IJ. Silicone breakdown and capsular synovial metaplasia in textured-wall saline breast prostheses Plast Reconstr Surg 1994,94 628-33
28. Vargas A. Shedding of silicone particles from inflated breast implants [Letter] Plast Reconstr Surg, 1979,64:252-3
29. Ortiz-Monasterio F, Trigos I. Management of patients with complications from injections of foreign materials into the breasts Plast Reconstr Surg 1972,50 42-7
30. Delage C, Shane JJ, Johnson FB. Mammary silicone granuloma Migration of silicone fluid to abdominal wall and inguinal region. Arch Dermatol 1973,108 104-7
31. Ellenbogen R, Rubin L. Injectable fluid silicone therapy. Human morbidity and mortality. JAMA 1975,234 308-9
32. Travis WD, Balogh K, Abraham JL. Silicone granulomas report of three cases and review of the literature Hum Pathol 1985,16 19-27.
33. Chen YM, Lu CC, Perng RP. Silicone fluid-induced pulmonary embolism Am Rev Respir Dis. 1993,147.1299-302
34. Capozzi A, Du Bou R, Pennisi VR. Distant migration of silicone gel from a ruptured breast implant. Case report Plast Reconstr Surg. 1978;62.302-3
35. Levine RA, Collins TL. Definitive diagnosis of breast implant rupture by ultrasonography Plast Reconstr Surg 1991,87 1126-8
36. Persellin ST, Vogler JB 3d, Brazis PW, Moy OJ. Detection of migratory silicone pseudotumor with use of magnetic resonance imaging Mayo Clin Proc 1992,67 891-5
37. Hausner RJ, Schoen FJ, Pierson KK. Foreign-body reaction to silicone in axillary lymph nodes after augmentation mammoplasty Plast Reconstr Surg 1978,62 381-4
38. Silver RM, Sahn EE, Allen JA, Sahn S, Greene W, Maize JC, et al. Demonstration of silicon in sites of connective-tissue disease in patients with silicone-gel breast implants Arch Dermatol 1993,129.63-8
39. Silicone gel breast implants Council on Scientific Affairs. American Medical Association JAMA. 1993;270 2602-6
40. Shankar R, Greisler HP. Inflammation and biomaterials In Greco RS Implantation Biology. The Host Response and Biomedical Devices Boca Raton, FL: CRC Pr; 1994 68-80
41. Copeland M, Choi M, Bleiweiss IJ. Silicone breakdown and capsular synovial metaplasia in textured-wall saline breast prostheses Plast Reconstr Surg 1994,94 634-6
42. Burkhardt BR. Capsular contracture hard breasts, soft data. Clin Plast Surg 1988,15 521-32
43. Bostwick J 3d. Plastic and Reconstructive Breast Surgery St Louis Quality Medical Publishing, 1990 181
44. Ashbell TS. Outpatient breast surgery under intercostal block anesthesia Plast Reconstr Surg 1980,65 239-40
45. Capozzi A. Polyurethane-covered gel mammary implants [Letter] Plast Reconstr Surg. 1982,69.904.
46. Asplund O. Capsular contracture in silicone gel and saline-filled breast implants after reconstruction Plast Reconstr Surg 1984,73:270-5
47. Gylbert L, Asplund O, Jurell G. Capsular contracture after breast reconstruction with silicone-gel and saline-filled implants a 6-year follow-up. Plast Reconstr Surg 1990,85 373-7.
48. Coleman DJ, Foo IT, Sharpe DT. Textured or smooth implants for breast augmentation? A prospective controlled trial Br J Plast Surg 1991;44 444-8.
49. Biggs TM, Cukier J, Worthing LF. Augmentation mammaplasty, a review of 18 years. Plast Reconstr Surg. 1982,69.445-50.
50. McKinney P, Tresley G. Long-term comparison of patients with gel and saline mammary implants Plast Reconstr Surg. 1983,72 27-9.
51. Cairns TS, de Villiers W. Capsular contracture after breast augmentation - a comparison between gel- and saline-filled prostheses S Afr Med J. 1980,57:951-3
52. Shapiro MA. Smooth vs. rough an 8-year survey of mammary prostheses Plast Reconstr Surg 1989,84.449-57
53. Ersek RA. Rate and incidence of capsular contracture: a comparison of smooth and textured silicone double-lumen breast prostheses. Plast Reconstr Surg. 1991,87.879-83.
54. Pollock H. Breast capsular contracture a retrospective study of textured versus smooth silicone implants Plast Reconstr Surg 1993,91 404-7.
55. Ellenberg AH, Braun H. A 3 1/2-year experience with double-lumen implants in breast surgery Plast Reconstr Surg. 1980;65:307-13
56. Thomsen JL, Christensen L, Nielsen M, Brandt B, Breiting VB, Felby S, Nielsen H. Histologic changes and silicone concentrations in human breast tissue surrounding silicone breast prostheses. Plast Reconstr Surg. 1990;85: 38-41
57. Smahel J. Histology of the capsules causing constrictive fibrosis around breast implants Br J Plast Surg 1977,30:324-9.
58. Domanskis EJ, Owsley JQ. Histological investigation of the etiology of capsule contracture following augmentation mammaplasty Plast Reconstr Surg. 1976;58 689-93
59. Burkhardt BR, Dempsey PD, Schnur PL, Tofield JJ. Capsular constracture: a prospective study of the effect of local antibacterial agents. Plast Reconstr Surg 1986;77:919-30
60. Gruber RP, Friedman G. The pressures generated by dosed capsulotomies of augmented breasts. Plast Reconstr Surg 1978;6 379-80.
61. Bostwick J. Plastic and Reconstructive Surgery St Louis Quality Medical Publishing; 1990.272-3.
62. Huang TT. Breast and subscapular pain following submuscular placement of breast prostheses Plast Reconstr Surg. 1990,86:275-80.
63. Siltex and Smooth Surface low-bleed gel-filled mammary prostheses (reconstruction adjunct study) Manufacturer's labeling Mentor H/S 1992.
64. Deloach ED, Lord SA, Ruf LE. Unilateral galactocele following augmentation mammoplasty. Ann Plast Surg 1994,33.68-71
65. Kumagai Y, Shiokawa Y, Medsger TA Jr, Rodnan GP. Clinical spectrum of connective tissue disease after cosmetic surgery Observations on eighteen patients and a review of the Japanese literature Arthritis Rheum 1984, 27.1-12
66. Weisman MH, Vecchione TR, Albert D, Moore LT, Mueller MR. Connective-tissue disease following breast augmentation: a preliminary test of the human adjuvant disease hypothesis Plast Reconstr Surg 1988;82 626-30.
67. Brody GS, Conway DP, Deapen DM, Fisher JC, Hochberg MC, LeRoy EC, et al. Consensus statement on the relationship of breast implants to connective-tissue disorders Plast Reconstr Surg 1992,90:1102-5
68. Goldman JA, Greenblatt J, Joines R, White L, Aylward B, Lamm SH. Breast implants, rheumatoid arthritis, and connective tissue diseases in a clinical practice. J Clin Epidemiol 1995,48:571-82.
69. Wells KE, Cruse CW, Baker JL Jr, Daniels SM, Stern RA, Newman C, et al. The health status of women following cosmetic surgery. Plast Reconstr Surg 1994,93 907-12
70. Giltay EJ, Bernelot Moens HJ, Riley AH, Tan RG. Silicone breast prostheses and rheumatic symptoms: a retrospective follow up study Ann Rheum Dis. 1994;53.194-6.
71. Schusterman MA, Kroll SS, Reece GP, Miller MJ, Ainslie N, Halabi S, et al. Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary report. Ann Plast Surg 1993,31.1-6.
72. Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Mellon LJ 3d. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994,330 1697-702
73. Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. 1995,322:1666-70
74. Silman AJ, Hochberg MC. Epidemiology of the Rheumatic Diseases. Oxford Oxford Univ Pr, 1993.193
75. Dugowson CE, Daling J, Koepsell TD, Voyt L, Nelson JL. Silicone breast implants and the risk for rheumatoid arthritis [Abstract] Arthritis Rheum 1992,35(Suppl) S66
76. Strom BL, Reidenberg MM, Freundlich B, Schinnar R. Breast silicone implants and risk of systemic lupus erythematosus J Clin Epidemiol 1994, 47:1211-4.
77. Wigley FM, Miller R, Hochberg MC, Stern V. Augmentation mammoplasty in patients with systemic sclerosis data from the Baltimore Scleroderma Research Center and Pittsburgh Scleroderma Data Bank [Abstract]. Arthritis Rheum. 1992,35(Suppl) S46
78. Hochberg MC, Perlmutter DL, White B, Steen V, Medsger TA, Weisman M, et al. The association of augmentation mammoplasty with systemic sclerosis results from a multi-center case-control study [Abstract]. Arthritis Rheum. 1994,37(Suppl).S369.
79. Burns CG. The Epidemiology of Systemic Sclerosis: A Population-Based Case-Control Study Doctoral dissertation Ann Arbor, MI University of Michigan, 1994.
80. Englert HJ, Brooks P. Scleroderma and augmentation mammoplasty - a causal relationship? Aust N Z J Med. 1994,24 74-80
81. Greenland S. Can meta-analysis be salvaged? Am J Epidemiol. 1994,140: 783-6
82. Shapiro S. Meta-analysis/Shmeta-anatysis Am J Epidemiol 1994,140:771-8
83. Perkins LL, Clark BD, Klein PJ, Cook RR. A meta-analysis of breast implants and connective tissue disease Ann Plast Surg 1995;35 561-70
84. Berkel H, Birdsell DC, Jenkins H. Breast augmentation a risk factor for breast cancer? N Engl J Med 1992;326 1649-53.
85. Bryant H, Brasher P. Breast implants and breast cancer - reanalysis of a linkage study N Engl J Med 1995,332.1535-9.
86. Deapen DM, Brody GS. Augmentation mammaplasty and breast cancer: a 5-year update of the Los Angeles study. Plast Reconstr Surg. 1992;89 660-5.
87. Brinton LA, Nasca PC, Mallin K, Baptiste MS, Wilbanks GD, Richart RM. Case-control study of cancer of the vulva Obstet Gynecol 1990;75 859-66
88. Petit JY, Le MG, Mouriesse H, Rietjens M, Gill P, Contesso G, et al. Can breast reconstruction with gel-filled Silicone implants increase the risk of death and second primary cancer in patients treated by mastectomy for breast cancer? Plast Reconstr Surg. 1994,94 115-9
89. Malone KE, Stanford JL, Daling JR, Voigt LF. Implants and breast cancer [Letter] Lancet 1992;339 1365
90. McLaughlin JK, Fraumeni JF Jr, Olsen J, Mellemkjaer L. Re breast implants, cancer, and systemic sclerosis [Letter] J Natl Cancer Inst. 1994;86: 1424
91. McLaughlin JK, Fraumeni JF Jr, Nyren O, Adami HO. Silicone breast implants and risk of cancer [Letter]. JAMA. 1995;273.116.
92. Bassett LW, Hendrick RE, Bassford TL, Butler PF, Carter D, DeBor M, et al. Quality Determinants of Mammography Clinical practice guideline no 13. AHCPR publication no 95-0632. Rockville, MD. U S Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, 1994.
93. Shestak KC, Ganott MA, Harris KM, Losken HW. Breast masses in the augmentation mammaplasty patient. the role of ultrasound Plast Reconstr Surg. 1993,92.209-16
94. Eklund GW, Cardenosa G. The art of mammographic positioning. Radiol Clin North Am 1992;30 21-53
95. Hayes H Jr, Vandergrift J, Diner WC. Mammography and breast implants. Plast Reconstr Surg 1988;82:1-6
96. Eklund GW, Busby RC, Miller SH, Job JS. Improved imaging of the augmented breast. AJR Am J Roentgenol. 1988,151:469-73.
97. Silverstein MJ, Handel N, Gamagami P, Gierson ED, Furmanski M, Collins AR, et al. Breast cancer diagnosis and prognosis in women following augmentation with Silicone gel-filled prostheses Eur J Cancer. 1992,28: 635-40.
98. Silverstein MJ, Gamagami P, Handel N. Missed breast cancer in an augmented woman using implant displacement mammography Ann Plast Surg 1990,25 210-3
99. Douglas KP, Bluth EI, Sauter ER, McKinnon WM, Bergeron RB, Merritt CR, et al. Roentgenographic evaluation of the augmented breast South Med J 1991,84.49-54
100. Leibman AJ, Kruse B. Breast cancer: mammographic and sonographic findings after augmentation mammoplasty Radiology. 1990;174 195-8
101. Grace GT, Roberts C, Cohen IK. The role of mammography in detecting breast cancer in augmented breasts Ann Plast Surg 1990;25:119-23.
102. Carlson GW, Curley SA, Martin JE, Fornage BD, Ames FC. The detection of breast cancer after augmentation mammaplasty Plast Reconstr Surg 1993;91 837-40
103. Schirber S, Thomas WO, Finley JM, Green AE Jr, Ferrara JJ. Breast cancer after mammary augmentation. South Med J 1993;86 263-8
104. Brinton LA, Toniolo P, Pasternack BS. Epidemiologic follow-up studies of breast augmentation patients J Clin Epidemiol 1995,48:557-63.