Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants

Journal of Biomedical Materials Research

Volumn 48, Issue 3, 1999, Pages 354-364

  Marotta, James S ^a   Widenhouse, Christopher W ^a   Habal, Mutaz B ^a,b   Goldberg, Eugene P ^a,c  

^a University of Florida   (United States)

^b Tampa Bay Craniofacial Center   (United States)

^c UNIVERSITY OF FLORIDA   (United States)

Author keywords

Explant analysis; Failure; Rupture; Silicone gel breast implants; Silicone implant complications

Indexed keywords

BIOMECHANICS; PROSTHETICS; SILICONES; SURGERY;

EXPLANT ANALYSIS; SHELL FAILURE; SHELL RUPTURE; SILICONE GEL BREAST IMPLANTS; SILICONE IMPLANT COMPLICATIONS;

IMPLANTS (SURGICAL);

ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; BREAST ENDOPROSTHESIS; FOOD AND DRUG ADMINISTRATION; PROSTHESIS FAILURE; RISK ASSESSMENT; SILICONE PROSTHESIS; STATISTICAL ANALYSIS; STRENGTH;

EID: 0033014326     PISSN: 00219304     EISSN: None     Source Type: Journal    
DOI: 10.1002/(sici)1097-4636(1999)48:3<354::aid-jbm21>3.0.co;2-%23     Document Type: Article

References (71)

1. Robinson OG, Bradley EL, Wilson DS. Analysis of explanted silicone implants: a report of 300 patients. Ann Plast Surg 1995;34:1-7.
2. Berg WA, Caskey CI, Hamper UM, et al. Single-and double-lumen silicone breast implant integrity: prospective evaluation of MR and US criteria. Radiology 1995;197:45-52.
3. de Camara DL, Sheridan JM, Kammer BA. Rupture and aging of silicone gel breast implants. Plast Reconstr Surg 1995;91: 828-834.
4. Rolland C, Guidoin R, Marceau D, Ledoux R. Nondestructive investigation of ninety-seven surgically excised mammary prostheses. J Biomed Mater Res 1989;23(Suppl. A3):285-298.
5. Guidoin R, Rolland C, King M. A non-destructive investigation to identify the failure mechanisms of 313 retrieved mammary prostheses. Proc Soc Biomater 1992;48.
6. Phillips JW, de Camara DL, Lockwood MD, Grebner CC. Strength of silicone breast implants. Plast Reconstr Surg 1996; 97:1215-1225.
7. Peters W, Keystone E, Smith D. Factors affecting the rupture of silicone-gel breast implants. Ann Plast Surg 1994;32:449-451.
8. Forsberg F, Conant EF, Russell KM, Moore JH. Quantitative ultrasonic diagnosis of silicone breast implant rupture: an in vitro feasibility study. Ultrasound Med Biol 1996;22:53-60.
9. Young VL, Brandon HJ, Jerina KL, Wolf C, Schorr MW. Failure characteristics of explanted breast implants. Proc Soc Biomater 1996;306.
10. Wolf CJ, Brandon HJ, Young VL, Jerina KL, Srivastava AP. Chemical, physical and mechanical analysis of explanted breast implants. Curr Topics Microbiol Immunol 1996;210:25-37.
11. Peters W, Smith D, Lugowski S, McHugh A, MacDonald P, Baines C. Silicone and silicone levels in patients with silicone implants. Curr Topics Microbiol Immunol 1996;210:39-48.
12. Gabriel SE, Woods JE, O'Fallon WM, Beard CM, Kurland LT, Melton LH. Complications leading to surgery after breast implantation. N Engl J Med 1997;336:677-682.
13. Malta CM, Varma S, Scott M, Liston JC, Sharpe DT. Silicone breast implant rupture: common/serious complication. Med Progress Technol 1994;20:251-260.
14. Shoaib BO, Patten BM, Calkins DS. Adjuvant breast disease: an evaluation of 100 symptomatic women with breast implants or silicone fluid injections. Keio J Med 1994;43:79-87.
15. Venta LA, Salomon CG, Flisak ME, Venta ER, Izquierdo R, Angelats J. Sonographic signs of breast implant rupture. Am J Roentgenol 1996;166:1413-1419.
16. McConnell JP, Moyer TP, Nixon DE, et al. Determination of silicon in breast and capsular tissue from patients with breast implants performed by inductively coupled plasma emission spectroscopy - comparison with tissue histology. Am J Clin Pathol 1997;107:236-246.
17. Ahn CY, Ko CY, Wagar EA, Wong RS, Shaw WW. Microbial evaluation: 139 implants removed from symptomatic patients. Plast Reconstr Surg 1996;98:1225-1229.
18. Peters W, Smith D, Lugowski S. Failure properties of 352 explanted silicone-gel breast implants. Can J Plast Surg 1996; 4:55-59.
19. Goldberg EP, Marotta JS, Widenhouse CW, Amery DP, Martin PJ. Data from ongoing University of Florida Biomaterials Center research.
20. Cohen BE, Biggs TM, Cronin ED, Collins DR. Assessment and longevity of the silicone gel breast implant. Plast Reconstr Surg 1997;99:1597-1601.
21. Beekman WH, Feitz R, Hage JJ, Mulder JW. Life span of silicone gel-filled mammary prostheses. Plast Reconstr Surg 1997;100:1723-1726.
22. Yeoh G, Russell P, Jenkins E. Spectrum of histological changes reactive to prosthetic breast implants: a clinopathological study of 84 patients. Pathology 1996;28:232-235.
23. Thomas WO, Harper LL, Wong SW, et al. Explantation of silicone breast implants. Am Surg 1997;63:421-429.
24. Lorenz R, Stark GB, Hedde JP. Significance of US for detection of complications after silicone implant for breast augmentation or reconstruction. Fortschr Rontgenstr 1997;166:233-237.
25. Reynolds HE, Buckwalter KA, Jackson VP, Siwy BK, Alexander SG. Comparison of mammography, sonography and magnetic resonance imaging in the detection of silicone-gel breast implant rupture. Ann Plast Surg 1994;33:247-257.
26. Ko CY, Ahn CY, Ko J, Chopra W, Shaw WW. Capsular synovial metaplasia as a common response to both textured and smooth implants. Plast Reconstr Surg 1996;97:1427-1433.
27. Caskey CI, Berg WA, Anderson ND, Sheth S, Chang BW, Hamper UM. Breast implant rupture: diagnosis with US. Radiology 1994;190:819-823.
28. Petro JA, Klein SA, Niazi Z, Salzberg CA, Byrne D. Evaluation of ultrasound as a tool in the follow-up of patients with breast implants: a preliminary prospective study. Ann Plast Surg 1994; 32:580-587.
29. Medot M, Landis GH, McGregor CE, et al. Effects of capsular contracture on ultrasonic screening for silicone gel breast implant rupture. Ann Plast Surg 1997;39:337-341.
30. Duffy MJ, Woods JE. Health risks of failed silicone gel breast implants: a 30-year clinical experience. Plast Reconstr Surg 1994;94:295-299.
31. Weizer G, Malone RS, Netscher DT, Walker LE, Thornby J. Utility of magnetic resonance imaging and ultrasound in diagnosing breast implant rupture. Ann Plast Surg 1995;34:352-361.
32. Melmed EP. A review of explantation in 240 symptomatic women: a description of explantation and capsulectomy with reconstruction using a periareolar technique. Plast Reconstr Surg 1998;101:1364-1373.
33. Palmon LU, Foshager M, Parantainen H, Everson LI, Cunningham B. Rupture or intact: what can linear echoes within silicone breast implants tell us? Am J Roentegenol 1997;168:1595-1598.
34. Middleton MS. Magnetic resonance evaluation of breast implants and soft-tissue silicone. Topics Magn Reson Imaging 1998;9:92-137.
35. Feng LJ. Significant findings on breast implant rupture from a seven year study of 1619 explants. Presented at the NAS-Institute of Medicine Workshop, July 22, 1998, Washington, DC, with additional data from personal communications.
36. Goldberg EP. Silicone breast implant safety: physical, chemical, and biological problems. Plast Reconstr Surg 1997;99:258-260.
37. Carpaneda CA. Inflammatory reaction and capsular contracture around smooth silicone implants. Aesth Plast Surg 1997;21: 110-114.
38. Ricci J, Alexander H, Steiner G, et al. Status of retrieved breast implants and their surrounding tissues. Proc Soc Biomater 1995; 327.
39. Ellenbogen R, Rubin L. Injectable fluid silicone therapy: human morbidity and mortality. J Am Med Assoc 1975;234:308-309.
40. Mukai N, Lee PF, Oguri M, Schepens CL. A long term evaluation of silicone retinopathy in monkeys. Can J Ophthal 1975; 10:391-402.
41. Spielvogel DE, Robinson RJ. Metabolism of octamethylcyclotetrasiloxane in the monkey. Dow Corning report 5265. Midland, MI: Dow Corning. 1980.
42. 4 to rats. Dow Corning report 1362-19. Midland, MI: Dow Coming. 1988.
43. 4) in rat urine. Dow Corning report 1997-10000-43454. Midland, MI: Dow Corning. 1997.
44. McCarty RN, Speier JL. Chemical research progress report 2964: on pharmacologically active substance believed to be present in DC 555 fluid. Midland, MI: Dow Corning. 1966.
45. Thompson RM, Howard CC, Brewer EJ, DeRoos FL, Hattery GR, Leininger R. Compostional analysis of silicone prostheses. Battelle report 233-77-5038 Task 6 to FDA. Battelle Institute, Columbus, OH. 1979.
46. Marotta JS, Goldberg EP. Extraction studies with breast implant silicone elastomer shells and "gels" indicate very high concentrations of soluble uncross-linked silicones. Proc Soc Biomater 1997;332.
47. Manikian M. Long term physical property evaluation of Silastic mammary prosthesis. Dow Corning report. Midland, MI: Dow Corning. 1971.
48. Peters S. Physical properties versus time for Silastic II and Standard prosthesis. Dow Corning report. Hemlock, MI: Dow Corning. 1981.
49. Greenwald DP, Randolph M, May JW. Mechanical analysis of explanted silicone breast implants. Plast Reconstr Surg 1996; 98:269-272.
50. van Rappard JH, Sonneveld GJ, van Twisk R, Borghouts JMHM. Pressure resistance of breast implants as a function of implantation time. Plast Reconstr Surg 1993;21:566-569.
51. Brandon H, Young VL, Wolf C, Jerina KL. Mechanical analysis of explanted breast implants. Proc Soc Biomater 1996;302.
52. Brandon HJ, Young VL, Jerina KL, Wolf CJ. Assessment of long term aging of silicone gel breast implants. Proc Soc Biomater 1998;369.
53. Marotta JS, Amery DP, Widenhouse CW, Martin PJ, Goldberg EP. Degradation of physical properties of silicone gel breast implants and high rates of implant failures. Proc Soc Biomater 1998;374.
54. Council on Scientific Affairs, American Medical Association. Silicone gel breast implants. J Am Med Assoc 1993;270:2602-2606.
55. Kessler DA, Merkatz RB, Schapiro R. A call for higher standards for breast implants. J Am Med Assoc 1993;270:2607-2608.
56. 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.
57. Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton JL. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994;330:1697-1702.
58. Brown SL, Silverman BG, Berg WA. Rupture of silicone-gel breast implants: causes, sequelae, and diagnosis. Lancet 1997; 350:1531-1537.
59. Sturrock RD, et al. Silicone gel breast implants: the report of the Independent Review Group. July 1998 report to the Chief Medical Officer requested by the UK Minister of Health.
60. Goldberg EP, Widenhouse C, Marotta J, Martin P. Failure of silicone gel breast implants: analysis of literature data for 1652 explanted prostheses. Plast Reconstr Surg 1997;100: 281-283.
61. Hartzel, JS. Personal communication.
62. Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective tissue diseases in female health professionals: a retrospective cohort study. J Am Med Assoc 1996; 275:616-621.
63. Angell M. Evaluating the health risks of breast implants: the interplay of medical science, the law and public opinion. N Engl J Med 1996;334:1513-1518.
64. Connell EB. The exploitation of autoimmune disease: breast implant litigation and its dire implications for women's health. J Women's Health 1998;7:329-338.
65. Angell M. Evaluating the health risks of breast implants: reply. N Engl J Med 1996;335:1156.
66. Goldberg EP. Evaluating the health risks of breast implants. N Engl J Med 1996;335:1154.
67. Rose NR. The silicone breast implant controversy: the other courtroom. J Arthritis Rheum 1996;39(10): 1615-1618.
68. Top 12 plastic/reconstructive surgery procedures in the U.S. Med Pro Month Med Data Int 1996;July/August: 166 (37 853 breast implant removals in 1994; from Am Soc Plast Reconstr Surg data).
69. Melmed EP. Silicone Implants: aesthetic triumph or surgical disaster? Plast Reconstr Surg 1996;98:1071-1073.
70. Deliberations of the 1991 to 1992 FDA Advisory Panel on Breast Implants. p 79-82.
71. Collis N, Sharpe DT. Breast implants: a survey of cosmetic clinics. Br J Plast Surg 1998;51:311-312.