Silicone gel implants in breast augmentation and reconstruction

Annals of Plastic Surgery

Volumn 59, Issue 5, 2007, Pages 581-590

  Gampper, Thomas J ^a,b   Khoury, Habib ^b   Gottlieb, Wendy ^c   Morgan, Raymond F ^a  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

^c University of Virginia Health System ^*

Author keywords

Augmentation; Breast cancer; Breast implant; Breast reconstruction; Capsular contracture; Elastomer; Gel bleed; Implant rupture; Mammoplasty; Silicone

Indexed keywords

ELASTOMER; POVIDONE IODINE; SILICONE GEL;

AUTOIMMUNE DISEASE; BREAST AUGMENTATION; BREAST CANCER; BREAST ENDOPROSTHESIS; BREAST FEEDING; BREAST RECONSTRUCTION; CONNECTIVE TISSUE DISEASE; CONTRACTURE; ESTHETIC SURGERY; EXPLANT; FOOD AND DRUG ADMINISTRATION; HUMAN; IMPLANT RUPTURE; MAMMOGRAPHY; PAIN; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; PROGNOSIS; REVIEW; RUPTURE; SILICONE PROSTHESIS; UNITED STATES;

AUTOIMMUNE DISEASES; BREAST; BREAST IMPLANTATION; BREAST IMPLANTS; FEMALE; HUMANS; MAMMAPLASTY; PROSTHESES AND IMPLANTS; PROSTHESIS FAILURE; RECONSTRUCTIVE SURGICAL PROCEDURES; SILICONE GELS; SILICONES; TREATMENT OUTCOME;

EID: 40349093033     PISSN: 01487043     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.sap.0000258970.31562.5d     Document Type: Review

References (117)

1. Cronin TD, Gerow FJ. Augmentation mammaplasty: a new "natural feel" prosthesis. Transactions of the Third International Congress of Plastic and Reconstructive Surgery. 1964;41-49.
2. Terry MB, Skovron ML, Garbers S, et al. The estimated frequency of cosmetic breast augmentation among U.S. women, 1963-1988. Am J Public Health. 1995;85:1122-1124.
3. Gerszten K, Gerszten PC. Silicone breast implants: an oncologic perspective. Oncology. 1998;12:1427-1433.
4. Brody GS. On the safety of breast implants. Plast Reconstr Surg. 1997;100:1314-1321.
5. Kessler DA. The basis of the FDA's decision on breast implant. N Engl J Med. 1992;326:1713-1715.
6. American Society for Esthetic Plastic Surgery. Statistics on Cosmetic Surgery 1999. American Society for Esthetic Plastic Surgery; 2000:3.
7. National clearinghouse of plastic surgery statistics [online]. Available at: http://www.plasticsurgery.org.
8. American Society of Plastic Surgeons [online]. Available at: http://www.plasticsurgery.org.
9. Sergent JS, Fuchs H, Johnson JS. Silicone implants and rheumatic diseases. In: Kelley WM, Harris ED, Ruddy S, et al, eds. Textbook of Rheumatology. 4th ed. Philadelphia: WB Saunders; 1993:1-13.
10. Brody GS. Silicone technology for the plastic surgeon. Clin Plast Surg. 1988;15:517-520.
11. Peters W. Current status of breast implant survival properties and the management of the woman with silicone gel breast implants. Can J Plast Surg. 2000;15:54-67.
12. Collis N, Sharpe DT. Silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants. Plast Reconstr Surg. 2000;105:1979-1989.
13. Feng LJ, Amini SB. Analysis of risk factors associated with rupture of silicone gel breast implants. Plast Reconstr Surg. 1999;104:955-963.
14. Hidalgo DA. Breast augmentation: choosing the optimal incision, implant, and pocket plane. Plast Reconstr Surg. 2000;105:2202-2216.
15. Bostwick J. Implants and expanders. In: Bostwick J, ed. Plastic and Reconstructive Breast Surgery, Vol. I. St. Louis: Quality Medical Publishing; 2000:187-238.
16. Bostwick J. Augmentation mammaplasty. In: Bostwick J, ed. Plastic and Reconstructive Breast Surgery, Vol. I. St. Louis: Quality Medical Publishing; 2000:239-270.
17. Tebbetts JB. Transaxillary subpectoral augmentation mammaplasty: a 9-year experience. Clin Plast Surg. 1988;15:557-568.
18. Tebbetts JB. Transaxillary subpectoral augmentation mammaplasty: long-term follow-up and refinements. Plast Reconstr Surg. 1984;74: 636-647.
19. Dempsey WC, Latham WD. Subpectoral implants in augmentation mammaplasty. Plast Reconstr Surg. 1968;42:515-521.
20. Regnault P. Partially submuscular breast augmentation. Plast Reconstr Surg. 1977;59:72-76.
21. Bostwick J. Tissue expansion reconstruction. In: Bostwick J, ed. Plastic and Reconstructive Breast Surgery, Vol. II. St. Louis: Quality Medical Publishing; 2000:811-866.
22. Gabriel SE, Woods JE, O'Fallon WM, et al. Complications leading to surgery after breast implantation. N Engl J Med. 1997;336:677-682.
23. McKinney P, Tresley G. Long-term comparison of patients with gel and saline mammary implants. Plast Reconstr Surg. 1983;72:27-29.
24. Hester TR, Nahai F, Bostwick J, et al. A 5-year experience with polyurethane-covered mammary prostheses for treatment of capsular contracture, primary augmentation mammaplasty, and breast reconstruction. Clin Plast Surg. 1988;15:569-585.
25. Handel N, Jensen JA, Black Q, et al. The fate of breast implants: a critical analysis of complications and outcomes. Plast Reconstr Surg. 1995;96:1521-1533.
26. Ross R, Woodward M. Absence of visible bacteria in capsules around breast implants. Plast Reconstr Surg. 1983;72:32-35.
27. Gylbert L, Asplund O, Berggren A, et al. Preoperative antibiotics and capsular contracture in augmentation mammaplasty. Plast Reconstr Surg. 1990;86:260-267.
28. Vazquez B, Given KS, Houston C. Breast augmentation: a review of subglandular and submuscular implantation. Aesthetic Plast Surg. 1987;11:101-105.
29. Puckett CL, Croll GH, Reichel CA, et al. A critical look at capsule contracture in subglandular versus subpectoral mammary augmentation. Aesthetic Plast Surg. 1987;11:23-28.
30. Williams C, Aston S, Rees TD. The effect of hematoma on the thickness of pseudosheaths around silicone implants. Plast Reconstr Surg. 1975;56:194-198.
31. Hetter GP. Satisfactions and dissatisfactions of patients with augmentation mammaplasty. Plast Reconstr Surg. 1979;64:151-155.
32. Asplund O, Gylbert L, Jurell G, et al. Textured or smooth implants for submuscular breast augmentation: a controlled study. Plast Reconstr Surg. 1996;97:1200-1205.
33. Mahler D, Hauben DJ. Retromammary versus retropectoral breast augmentation: a comparative study. Ann Plast Surg. 1982;8:370-374.
34. Spear SL, Baker JL. Classification of capsular contracture after prosthetic breast reconstruction. Plast Reconstr Surg. 1995;96:1119-1123.
35. Luke JL, Kalasinsky VF, Turnicky RP, et al. Pathological and biophysical findings associated with silicone breast implants: a study of capsular tissues from 86 cases. Plast Reconstr Surg. 1997;100:1558-1565.
36. Siggelkow W, Faridi A, Spiritus K, et al. Histological analysis of silicone breast implant capsules and correlation with capsular contracture. Biomaterials. 2003;24:1101-1109.
37. Dolores W, Christian R, Harald N, et al. Cellular and molecular composition of fibrous capsules formed around silicone breast implants with special focus on local immune reactions. J Autoimmun. 2004;23: 81-91.
38. Burkhardt BR. Capsular contracture: hard breast, soft data. Clin Plast Surg. 1988;15:521-532.
39. Asplund O. Capsular contracture in silicone gel and saline-filled breast implants after reconstruction. Plast Reconstr Surg. 1984;73:270-275.
40. Evans GR, Schusterman MA, Kroll SS, et al. Reconstruction and the radiated breast: is there a role for implants? Plast Reconstr Surg. 1995;96:1111-1118.
41. Vandeweyer E, Deraemaecker R. Radiation therapy after immediate breast reconstruction with implants. Plast Reconstr Surg. 2000;106: 56-58.
42. Perrin ER. The use of soluble steroids within inflatable breast prostheses. Plast Reconstr Surg. 1976;57:163-166.
43. Oneal RM, Argenta LC. Late side effects related to inflatable breast prostheses containing soluble steroids. Plast Reconstr Surg. 1982;69: 641-645.
44. Burkhardt BR, Dempsey PD, Schnur PL, et al. Capsular contracture: a prospective study of the effect of local antibacterial agents. Plast Reconstr Surg. 1986;77:919-930.
45. Adams WP, Conner CH, Barton FE, et al. Optimizing breast pocket irrigation: an in vitro study and clinical implications. Plast Reconstr Surg. 2000;105:334-341.
46. Zambacos GJ, Nguyen D, Morris RJ. Effect of povidone iodine on silicone gel breast implants in vitro: implications for clinical practice. Plast Reconstr Surg. 2004;114:706-710.
47. Camirand A, Doucet J, Harris J. Breast augmentation: compression: a very important factor in preventing capsular contracture. Plast Reconstr Surg. 1999;104:529-538.
48. Brand KG. Foam-covered mammary implants. Clin Plast Surg. 1988; 15:533-539.
49. Collis N, Coleman D, Foo ITH, et al. Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants. Plast Reconstr Surg. 2000;106:786-791.
50. Hakelius L, Ohlsen L. Tendency to capsular contracture around smooth and textured gel-filled silicone mammary implants: a 5-year follow-up. Plast Reconstr Surg. 1997;100:1566-1569.
51. Malata CM, Feldberg L, Coleman DJ, et al. Textured or smooth implants for breast augmentation? three year follow-up of a prospective randomized controlled trial. Br J Plast Surg. 1997;50:99-105.
52. Wong S, Tan S. Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: a systemic review. Plast Reconstr Surg. 2006;118:1224-1236.
53. Woods JE, Irons GB, Arnold PG. The case for submuscular implantation of prostheses in reconstructive breast surgery. Ann Plast Surg. 1980;5:115-122.
54. Biggs TM, Yarish RS. Augmentation mammaplasty: retropectoral versus retromammary implantation. Clin Plast Surg. 1988;15:549-555.
55. Hammond DC, Hidalgo D, Slavin S, et al. Revising the unsatisfactory breast augmentation. Plast Reconstr Surg. 1999;104:277-283.
56. Collis N, Sharpe DT. Recurrence of subglandular breast implant capsular contracture: anterior versus total capsulectomy. Plast Reconstr Surg. 2000;106:792-797.
57. Cohen BE, Biggs TM, Cronin ED, et al. Assessment and longevity of the silicone gel breast implant. Plast Reconstr Surg. 1997;99:1597-1601.
58. Robinson OG, Bradley EL, Wilson DS. Analysis of explanted silicone implants: a report of 300 patients. Ann Plast Surg. 1995;34:1-7.
59. Holmich LR, Friis S, Vejborg IM, et al. Incidence of silicone breast implant rupture. Arch Surg. 2003;138:801-806.
60. Marotta JS, Goldberg EP, Habal MB, et al. Silicone gel breast implant failure: evaluation of properties of shells and gels for explanted prostheses and meta-analysis of literature rupture data. Ann Plast Surg. 2002;49:227-242.
61. Greenwald DP, Randolph M, May JW. Mechanical analysis of explanted silicone breast implants. Plast Reconstr Surg. 1996;98:269-275.
62. Phillips JW, deCamara DL, Lockwood MD, et al. Strength of silicone breast implants. Plast Reconstr Surg. 1996;97:1215-1225.
63. Brody GS. Discussion of "Mechanical analysis of explanted silicone breast implants" by DP Greenwald, M Randolph, JW May. Plast Reconstr Surg. 1996;98:273.
64. Brandon HJ, Jerina KL, Wolf CJ, et al. Ultimate strength properties of control and explanted Silastic 0 and Silastic I silicone gel-filled breast implant shells. Esthetic Surg J. 1999;19:381-387.
65. Brandon HJ, Jerina KL, Wolf CJ, et al. Ultimate strength properties of explanted and control Silastic II silicone gel-filled breast implant shells. Esthetic Surg J. 2000;20:122-132.
66. Holmich LR, Vejborg IM, Conrad C, et al. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004;114:204-214.
67. Holmich LR, Fryzec JP, Kjoller K, et al. The diagnosis of silicone breast-implant rupture: clinical findings compared with finding at magnetic resonance imaging. Ann Plast Surg. 2005;54:583-589.
68. Ikeda DM, Borofsky HB, Herfkens RJ, et al. Silicone breast implant rupture: pitfalls of magnetic resonance imaging and relative efficacies of magnetic resonance, mammography, and ultrasound. Plast Reconstr Surg. 1999;104:2054-2062.
69. Samuels JB, Rohrich RJ, Weatherall PT, et al. Radiographic diagnosis of breast implant rupture: current status and comparison of techniques. Plast Reconstr Surg. 1995;96:865-877.
70. Holmich LR, Vejborg I, Corad C, et al. The diagnosis of breast implant rupture: MRI findings compared with finding at explantation. Eur J Radiol. 2005;53:213-225.
71. Berg WA, Nguyen TK, Middleton MS, et al. MR imaging of extracapsular silicone from breast implants: diagnostic pitfalls. Am J Roentgenol. 2002;178:465-472.
72. Chung KC, Greenfield ML, Walters M. Decision-analysis methodology in the work-up of women with suspected silicone breast implant rupture. Plast Reconstr Surg. 1998;102:689-695.
73. Barker DE, Ratsky MI, Schultz S. "Bleeding" of silicone from bag-gel breast implants, and its clinical relation to fibrous capsule reaction. Plast Reconstr Surg. 1978;61:836-841.
74. Evans GRD, Netscher DT, Schusterman MA, et al. Silicone tissue assays: a comparison of nonaugmented cadaveric and augmented patient levels. Plast Reconstr Surg. 1996;97:1207-1213.
75. Barnard JJ, Todd EL, Wilson WG, et al. Distribution of organosilicon polymers in augmentation mammaplasties at autopsy. Plast Reconstr Surg. 1997;100:197-203.
76. Peters W, Smith D, Lugowski S. Silicon assays in women with and without silicone gel breast implants: a review. Ann Plast Surg. 1999; 43:324-330.
77. Birkefeld AB, Eckert H, Pfleiderer B. A study of the aging of silicone breast implants using 29Si, 1H relaxation and DSC measurements. Biomaterials. 2004;25:4405-4413.
78. Weinzweig J, Schnur PL, McConnell JP, et al. Silicon analysis of breast and capsular tissue from patients with saline or silicone gel breast implants: II correlation with connective-tissue disease. Plast Reconstr Surg. 1998;101:1836-1841.
79. Schnur PL, Weinzweig J, Harris JB, et al. Silicon analysis of breast and periprosthetic capsular tissue from patients with saline or silicone gel breast implants. Plast Reconstr Surg. 1996;98:798-803.
80. Bitar GJ, Nguyen DB, Knox LK, et al. Shur-Clens: an agent to remove silicone gel after breast implant rupture. Ann Plast Surg. 2002;48:148-153.
81. Van Nunen SA, Gatenby PA, Basten A. Post-mammoplasty connective tissue disease. Arthritis Rheum. 1982;25:694-697.
82. Sanchez-Guerrero J, Coldite GA, Karlson EW, et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. 1995;332:1666-1670.
83. Giltay EJ, Bernelot Moens HJ, Riley AH, et al. Silicone breast prostheses and rheumatic symptoms: a retrospective follow-up study. Ann Rheum Dis. 1994;53:194-196.
84. Gabriel SE, O'Fallon WM, Kurland LT, et al. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med. 1994;330:1697-1702.
85. Blackburn WD, Everson MP. Silicone-associated rheumatic disease: an unsupported myth. Plast Reconstr Surg. 1997;99:1362-1367.
86. Lipworth L, Tarone RE, McLaughlin JK. Breast implants and fibromyalgia: a review of the epidemiologic evidence. Ann Plast Surg. 2004;52:284-287.
87. Silverman BG, Brown SL, Bright RA, et al. Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med. 1996;124:744-756.
88. Wong O. A critical assessment of the relationship between silicone breast implants and connective tissue disease. Regulat Toxicol Pharmacol. 1996;23:74-85.
89. Janowsky EC, Kupper LL, Hulke BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342:781-790.
90. Cancer Care, Inc. Cancer care library: do you know these facts about breast cancer? Available at: http://www.cancercare.org/patients/facts.htm.
91. Deapen DM, Bernstein L, Brody GS. Are breast implants anticarcinogenic? a 14-year follow-up of the Los Angeles study. Plast Reconstr Surg. 1997;99:1346-1353.
92. Rohrich RJ. Safety of silicone breast implants: scientific validation/vindication at last. Plast Reconstr Surg. 1999;104:1786-1788.
93. Berkel H, Birdsell DC, Jenkins H. Breast augmentation: a risk factor for breast cancer? N Engl J Med. 1992;326:1649-1653.
94. Kern KA, Flannery JT, Kuehn PG. Carcinogenic potential of silicone breast implants: a Connecticut statewide study. Plast Reconstr Surg. 1997;100:737-747.
95. Bryant H, Brasher P. Breast implants and breast cancer: reanalysis of a linkage study. N Engl J Med. 1995;332:1535.
96. Petit J, Le M, Mouriesse H, 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;94:115-119.
97. Birdsell DC, Jenkins H, Berkel H. Breast cancer diagnosis and survival in women with and without breast implants. Plast Reconstr Surg. 1993;92:795-800.
98. Deapen D, Hamilton A, Bernstein L, et al. Breast cancer stage at diagnosis and survival among patients with prior breast implants. Plast Reconstr Surg. 2000;105:535-540.
99. Brinton LA, Brown L. Breast implants and cancer. J Natl Cancer Inst. 1997;89:1341-1349.
100. McLaughlin JK, Fraumeni JF, Oslen J, et al. Re Breast implants, cancer, and systemic sclerosis. J Natl Cancer Inst. 1994;86:1424.
101. Friis S, McLaughlin JK, Mellemkjer L, et al. Breast implants and cancer risk in Denmark. Int J Cancer. 1997;71:956-958.
102. Kern KA, Flannery JT, Kuehn PG. Carcinogenic potential of silicone breast implants: a Connecticut state wide study. Plast Reconstr Surg. 1997;100:737-747.
103. Deapen DM, Brody GS. Augmentation mammaplasty and breast cancer: a 5-year update of the Los Angeles study. Plast Reconstr Surg. 1992;89:660-665.
104. Expert panel in the safety of polyurethane-covered breast implants: safety of polyurethane-covered breast implants. CMAJ. 1991;145:1125-1128.
105. Hester TR, Ford NF, Gale PJ, et al. Measurement of 2,4-toluenediamine in urine and serum samples from women with Meme or Replicon breast implants. Plast Reconstr Surg. 1997;100:1291-1298.
106. Handel N, Silverstein MJ, Gamagami P, et al. Factors affecting mammographic visualization of the breast after augmentation mammaplasty. JAMA. 1992;268:1913-1917.
107. Eklund GW, Cardenosa G. The art of mammographic positioning. Radiol Clin North Am. 1992;30:21-53.
108. Silverstein MJ, Handel N, Gamagami P, et al. Breast cancer diagnosis and prognosis in women following augmentation with silicone gel-filled prostheses. Eur J Cancer. 1992;28:635-640.
109. Food and Drug Administration Advisory Panel Transcripts, General and Plastic Surgery Devices Panel. Gaithersburg, MD: FDA; 1992:146.
110. Raso DS, et al. Elemental analysis and clinical implications of calcification deposits associated with silicone breast implants. Ann Plast Surg. 1999;42:117-123.
111. Levine JJ, Ilowite NT. Sclerodermalike esophageal disease in children breast-fed by mothers with silicone breast implants. JAMA. 1994;271: 213-216.
112. Kjoller K, McLaughlin JK, Friis S, et al. Health outcomes in offspring of mothers with breast implants. Pediatrics. 1998;102:1112-1115.
113. Medical Devices Agency. Silicone Implants and Connective Tissue Disease. London: Department of Health; 1994:35.
114. Rohrich RJ, Rathakrshnan R, Robinson JB, et al. Factors predictive of quality of life after silicone-implant explantation. Plast Reconstr Surg. 1999;104:1334-1337.
115. Rohrich RJ, Kenkel JM, Adams WP, et al. A prospective analysis of patients undergoing silicone breast implant explantation. Plast Reconstr Surg. 2000;105:2529-2537.
116. Sciosa PJ, Hagerty RC. Internal mastopexy following explantation. Plast Reconstr Surg. 1996;97:1014-1019.
117. Netscher DT, Sharma S, Thornby J, et al. Esthetic outcome of breast implant removal in 85 consecutive patients. Plast Reconstr Surg. 1997;100:206-219.