Long-term safety and efficacy of polyurethane foam-covered breast implants

Aesthetic Surgery Journal

Volumn 26, Issue 3, 2006, Pages 265-274

  Handel, Neal ^a   Gutierrez, Jaime ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

2,4 DIAMINOTOLUENE; 2,6 DIAMINOTOLUENE; 2,6 TOLUENE DIISOCYANATE; CARCINOGEN; POLYURETHAN FOAM; SILICONE GEL; TOLUENE DIISOCYANATE; TOLUENE ISOCYANATE AMINE; UNCLASSIFIED DRUG;

ARTICLE; BREAST AUGMENTATION; BREAST CANCER; BREAST ENDOPROSTHESIS; BREAST RECONSTRUCTION; CARCINOGENICITY; COMPUTER PROGRAM; CONTRACTURE; CONTROLLED STUDY; FACTUAL DATABASE; HEMATOMA; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MEDICAL RECORD; MORBIDITY; OUTCOMES RESEARCH; PATIENT SATISFACTION; POPULATION RESEARCH; POSTAL MAIL; POSTOPERATIVE INFECTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUESTIONNAIRE; RASH; REOPERATION; RISK REDUCTION; SAFETY; SILICONE PROSTHESIS; STATISTICAL ANALYSIS;

EID: 33745046301     PISSN: 1090820X     EISSN: 1527330X     Source Type: Journal    
DOI: 10.1016/j.asj.2006.04.001     Document Type: Article

References (44)

1. Handel N. Managing local implant-related problems. In: Spear S. (Ed). Surgery of the Breast: Principles and Art (1998), Lippincott-Raven, Philadelphia 953-968
2. Ashley F. A new type of breast prosthesis: preliminary report. Plast Reconstr Surg 45 (1970) 421-424
3. Ashley F. Further studies on the natural-Y breast prosthesis. Plast Reconstr Surg 49 (1972) 414-419
4. Handel N., Silverstein M., Jensen J., Collins A., and Zieck K. Comparative experience with smooth and polyurethane breast implants using the Kaplan-Meier method of survival analysis. Plast Reconstr Surg 88 (1991) 475-481
5. Hoffman S. Correction of established capsule contracture with polyurethane implants. Aesthetic Plast Surg 13 (1989) 33-40
6. Batich C., and Williams J. Toxic hydrolysis product from biodegradable foam implant. J Biomed Mater Res 23 (1989) 311-319
7. Food and Drug Administration. FDA advisory committee meeting on polyurethane-coated breast implants (Talk Paper). Rockville, MD: Aug 1, 1991.
8. Burkhardt B. Comparing contracture rates: probability theory and the unilateral contracture. Plast Reconstr Surg 74 (1984) 527-529
9. Mahler D., and Hauben D. Retromammary versus retropectoral breast augmentation. Ann Plast Surg 8 (1982) 370-374
10. Brand K. Infection of mammary prostheses: a survey and the question of prevention. Ann Plast Surg 30 (1993) 289-295
11. Hester T. Diagnosis and treatment of complications occurring with polyurethane-covered breast implants. Persp Plast Surg 4 (1990) 105-111
12. Herman S. The Meme implant. Plast Reconstr Surg 73 (1984) 411-414
13. Hester T., Nahai F., Bostwick J., and Cukic J. A 5-year experience with polyurethane-covered mammary prostheses for treatment of capsular contracture, primary augmentation mammaplasty, and breast reconstruction. Clin Plast Surg 15 (1988) 569-585
14. Capozzi A., and Pennisi V. Clinical experience with polyurethane-covered gel-filled mammary prostheses. Plast Reconstr Surg 68 (1981) 512-520
15. Handel N., Jensen J., Black Q., et al. The fate of breast implants: a critical analysis of complications and outcomes. Plast Reconstr Surg 96 (1995) 1521-1533
16. Worseg A., Kuzbari R., Tairych G., Korak K., and Holle J. Long-term results of inflatable mammary implants. Br J Plast Surg 48 (1995) 183-188
17. Berrino P., Galli A., Rainero M., and Santi P. Long-lasting complications with the use of polyurethane-covered breast implants. Br J Plast Surg 39 (1986) 549-553
18. Eyssen J., von Werssowetz A., and Middleton G. Reconstruction of the breast using polyurethane-coated prostheses. Plast Reconstr Surg 73 (1984) 415-421
19. Gasperoni C., Salgarello M., and Gargani G. Polyurethane-covered mammary implants: a 12-year experience. Ann Plast Surg 29 (1992) 303-308
20. Pennisi V. Polyurethane-covered silicone gel mammary prosthesis for successful breast reconstruction. Aesthetic Plast Surg 9 (1985) 73-77
21. Melmed E. Polyurethane implants: a 6-year review of 416 patients. Plast Reconstr Surg 82 (1988) 285-290
22. Bruck H. Long-term results of polyurethane-covered prostheses. Aesthetic Plast Surg 14 (1990) 85-86
23. Biggs T., Cukier J., and Worthing L. Augmentation mammaplasty: a review of 18 years. Plast Reconstr Surg 69 (1982) 445-452
24. Handel N. Managing complications of breast augmentation. In: Shenaq S. (Ed). Perspectives in Plastic Surgery (2001), Thieme Medical Publishers, New York 11-30
25. Brandt B., Christensen B., Nielsen M., and Thomsen J. Five years experience of breast augmentation using silicone gel prostheses with emphasis on capsule shrinkage. Sc and J Plast Reconstr Surg 18 (1984) 311-316
26. Karp R., Johnson K., Buoen L., Ghobrial H., Brand I., and Brand K. Tumorigenesis by Millipore filters in mice: histology and ultrastructure of tissue reactions as related to pore size. J Natl Cancer Inst 51 (1973) 1275-1285
27. Rigdon R. Local reaction to polyurethane - a comparative study in the mouse, rat and rabbit. J Biomed Mater Res 7 (1973) 79-93
28. Imber G., Schwager R., Guthrie R., and Gray G. Fibrous capsule formation after subcutaneous implantation of synthetic materials in experimental animals. Plast Reconstr Surg 54 (1974) 183-186
29. Picha G., Goldstein J., and Stohr E. Natural-Y Meme polyurethane versus smooth silicone: Analysis of the soft-tissue interaction from 3 days to 1 year in the rat animal model. Plast Reconstr Surg 85 (1990) 903-916
30. Smahel J. Tissue reaction to breast implants coated with polyurethane. Plast Reconstr Surg 61 (1978) 80-85
31. Wang B., Chang B., Sargeant R., and Manson P. Late capsular hematoma after breast Reconstruction with polyurethane-covered implants. Plast Reconstr Surg 102 (1998) 450-452
32. Slade L., and Peterson H. Disappearance of the polyurethane cover of the Ashley Natural Y prosthesis. Plast Reconstr Surg 70 (1982) 379-383
33. Hollenberg C., Macoomb R., Trott J., and Zing W. An investigation of polyurethane foam in experimental animals. Can J Surg 6 (1963) 371-382
34. Szycher M., and Siciliano A. Polyurethane-covered mammary prosthesis: a nine-year follow-up assessment. J Biomaterials App 5 (1991) 282-322
35. Hester T. The polyurethane-covered mammary prosthesis: facts and fiction. Persp Plast Surg 2 (1988) 135-169
36. Sinclair T., Kerrigan C., and Buntic R. Biodegradation of the polyurethane foam covering of breast implants. Plast Reconstr Surg 92 (1993) 1003-1013
37. Guidoin R., Therrien M., Rolland C., King M., Grandmaison J., Kaliagnine S., et al. The polyurethane foam covering the Meme breast prosthesis: a biomedical breakthrough or a biomaterial tar baby?. Ann Plast Surg 28 (1992) 342-353
38. Kerrigan C. Report on the Meme breast implant. Prepared for the Minister of Health and Welfare, Canada (hon. Perrin Beatty) (May 1989), McGill University, Montréal, Quebec
39. Benoit F. Degradation of polyurethane foams used in the Meme breast implant. J Biomed Mat Res 27 (1993) 1341-1348
40. Chan S., Birdsell D., and Gradeen C. Case report: detection of toluenediamines in the urine of a patient with polyurethane-covered breast implants. Clin Chem 37 (1991) 2143-2145
41. Amin P., Wille J., Shah K., and Kydonieus A. Analysis of the extractive and hydrolytic behavior of micorthane poly(ester-urethane) foam by high pressure liquid chromatography. J Biomed Mat Res 27 (1993) 655-664
42. Hester T., Ford N., Gale P., Hammett J., Raymond R., Turnbull D., et al. Measurement of 2,4-toluenediame in urine and serum samples from women with Meme or Replicon breast implants. Plast Reconstr Surg 100 (1997) 1291-1298
43. Harris H. Survey of breast implants from the point of view of carcinogenesis. Plast Reconstr Surg 28 (1961) 81-83
44. McGrath M., and Burkhardt B. The safety and efficacy of breast implants for augmentation mammaplasty. Plast Reconstr Surg 74 (1984) 550-560