Skip to main content

Back to the Future: A 15-Year Experience With Polyurethane Foam-Covered Breast Implants Using the Partial-Subfascial Technique

Abstract

Background

Implants with a polyurethane foam cover have been used by plastic surgeons since Ashley described them in 1970. Overwhelming evidence confirms the benefits of these implants, especially the extremely low incidence of capsular contracture (grades 3 and 4, Baker classification). On the other hand, except for a transient and self-limited rash, there is no evidence that polyurethane implants present more complications than texturized or smooth gel implants. Due to concerns of polyurethane-induced cancer, these implants were withdrawn in United States after approximately 110,000 American women had received them. This fact, together with the probability that these implants will be reintroduced in the United States, suggests that continued monitoring of their long-term safety and effectiveness is mandatory.

Methods

A retrospective study analyzed the outcomes of 996 implants inserted during a period of 15 years. The incidence of early and late complications was analyzed as well as the aesthetic outcome.

Results

The complications evaluated included hematoma (0.6%), infection (0.4%), seroma (0.8%), rash (4.3%), wound dehiscence (0%), capsular contracture (0.4%), implant malposition (0.8%), need for revisional surgery (1.2%), implant rupture (0.7%), rippling (1.8%), and polyurethane-related cancer (0%). Regarding the aesthetic outcome, 95% of the patients expressed satisfaction with their final result.

Conclusion

The polyurethane foam-covered implants have been proven safe for use in breast surgery. They provide the lowest rate of capsular contracture (0.4% in the current study) and excellent aesthetic results.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9

References

  1. Ashley F (1970) A new type of breast prosthesis. Plast Reconstr Surg 45:421

    PubMed  Article  CAS  Google Scholar 

  2. Ashley FL (1972) Further studies on the natural-Y breast prothesis. Plast Reconstr Surg 49:414–419

    PubMed  Article  CAS  Google Scholar 

  3. Barone F, Perry L, Keller T, Maxell P (1992) The biomechanical and histopathologic effects of surface texturing with silicone and polyurethane in tissue implantation and expansion. Plast Reconstr Surg 90:77

    PubMed  Article  CAS  Google Scholar 

  4. Batich C, Williams J (1989) Toxic hydrolysis product from biodegradable foam implant. J Biomed Mater Res 23:311–319

    PubMed  Article  CAS  Google Scholar 

  5. Berrino P, Galli A, Rainero ML, Santi PL (1986) Long-lasting complications with the use of polyurethane-covered breast implants. Br J Plast Surg 39:549

    PubMed  Article  CAS  Google Scholar 

  6. Brand G (1988) Foam-covered mammary implants. Clin Plast Surg 15:533

    PubMed  CAS  Google Scholar 

  7. Brody GS (1984) Reconstruction of the breast using polyurethane-coated prostheses. Plast Reconstr Surg 73:420

    Article  Google Scholar 

  8. Bruck HG (1990) Long-term results of polyurethane-covered prostheses. Aesthetic Plast Surg 14:85–86

    PubMed  Article  CAS  Google Scholar 

  9. Bucky L, Ehrlich P, Sohoni et al (1994) The capsular quality of the saline-filled smooth silicone, textured silicone, and polyurethane implants in rabbits: A long-term study. Plast Reconstr Surg 93:1123

    PubMed  Article  CAS  Google Scholar 

  10. Capozzi A (1982) Clinical experience with polyurethane-covered gel mammary implants. Plast Reconstr Surg 69:904

    PubMed  CAS  Google Scholar 

  11. Capozzi A, Pennisi VR (1981) Clinical experience with polyurethane-covered gel-filled mammary prothesis. Plast Reconstr Surg 68:512

    PubMed  Article  CAS  Google Scholar 

  12. Cocke W, Leathers H, Lynch J (1975) Foreign body reactions to polyurethane cover of some breast prosthesis. Plast Reconstr Surg 56:527

    PubMed  Article  CAS  Google Scholar 

  13. Cohney B, Cohney T, Hearne V (1991) Nineteen years experience with polyurethane foam-covered mammary prosthesis: A preliminary report. Ann Plast Surg 27:27

    PubMed  Article  CAS  Google Scholar 

  14. Dolsky RL (1985) Inserting the Méme prosthesis. Plast Reconstr Surg 76:974

    PubMed  CAS  Google Scholar 

  15. Eyssen JE, Von Werssowetz AJ, Middleton GD (1984) Reconstruction of the breast using polyurethane-covered prosthesis. Plast Reconstr Surg 74:415

    Google Scholar 

  16. Food and Drugs Administration (FDA): Update: Study of TDA Released From Polyurethane Foam-Covered Breast Implants. FDA: 27 June 1995

  17. Gasperoni C, Salgarello M, Gargani G (1992) Polyurethane-covered mammary implants: A 12-year experience. Ann Plast Surg 29:303

    PubMed  Article  CAS  Google Scholar 

  18. Handel N (1991) Comparative experience with smooth and polyurethane breast implants using the Kaplan-Meier method survival analysis. Plast Reconstr Surg 88:475

    PubMed  Article  CAS  Google Scholar 

  19. Handel N, Guitierrez J (2006) long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthetic Surg J 26:265–274

    Article  CAS  Google Scholar 

  20. Herman S (1984) The Méme implant. Plast Reconstr Surg 73:411

    PubMed  Article  CAS  Google Scholar 

  21. Hester R, Cukic J (1991) Use of stacked polyurethane-covered mammary implants in aesthetic and reconstructive breast surgery. Plast Reconstr Surg 88:503

    PubMed  Article  Google Scholar 

  22. Hester R, Nahai F, Bostwick J et al (1988) A 5-year experience with polyurethane-covered mammary prosthesis for treatment of capsular contracture, primary augmentation mammoplasty, and the breast reconstruction. Clin Plast Surg 15:569

    PubMed  Google Scholar 

  23. Hoefflin S (1997) Extensive experience with polyurethane breast implants. Plast Reconstr Surg 100:1291–1298

    Article  Google Scholar 

  24. Hoffman S (1989) Correction of established capsule contracture with polyurethane implants. Aesthetic Plast Surg 13:33–40

    PubMed  Article  CAS  Google Scholar 

  25. Melmed EP (1988) Polyurethane implants: A 6-year review of 416 patients. Plast Reconstr Surg 82:285–290

    PubMed  Article  CAS  Google Scholar 

  26. Melmed EP (1990) Treatment of breast contracture with open capsulectomy and replacement of gel prosthesis with polyuretjane-covered implants. Plast Reconstr Surg 86:270

    PubMed  Article  CAS  Google Scholar 

  27. Pennisi VR (1985) Polyurethane-covered silicone gel mammary prostheses for successful breast reconstruction. Aesthetic Plast Surg 9:73–77

    PubMed  Article  CAS  Google Scholar 

  28. Pennisi V (1990) Long-term use of polyurethane breast prostesis: A 14-year experience. Plast Reconstr Surg 86:386

    Google Scholar 

  29. Pitanguy I, Bretano J, CastroRanalho Mde, Porto MJ (1990) Implante de Silicone gel com revestimento de poliuretano. Rev Brasil Cirugía 80:119

    Google Scholar 

  30. Rebello C: Mamoplastía de aumento com próteses mamárias de silicone revestidas de poliuretano. Rev Brasil Cirurgía Plást Estét Reconstr 8:58, Janeiro/Dezembro, 1993

    Google Scholar 

  31. Santerre JP, Wang FGB, Labow RS: Biodegradation of Microthane Polyester Polyurethane by the Lysosomal Enzyme Cholesterol Esterase and Identification of Degradation Products. 24th Annual Meeting of the Society for Biomaterials, San Diego, CA, April 1998

  32. Schatten W (1984) Reconstruction of breast following mastectomy with polyurethane-covered, gel-filled prosthesis. Ann Plast Surg 12:147

    PubMed  Article  CAS  Google Scholar 

  33. Sinclair T, Kerrigan C, Buntik R (1993) Biodegradation of the polyurethane foam covering of breast implants. Plast Reconstr Surg 92:1003

    PubMed  Article  CAS  Google Scholar 

  34. Smahel J (1987) Tissue reactions to breast implants coated with polyurethane. Plast Reconstr Surg 61:80

    Google Scholar 

  35. Spear SL (1999) Breast implant technology: What can we count on? Aesthetic Surg J 19:347–349

    Article  Google Scholar 

  36. Szycher M, Lee SI, Siciliano A (1991) Breast prosthesis: A critical revew. J Biomat Appl 5:256

    Article  CAS  Google Scholar 

  37. Vasquez G, Pellon A (2007) Polyurethane-coated silicone gel breast implants used for 18 years. Aesthetic Plast Surg 31:330–336

    Article  Google Scholar 

  38. Vázquez G (1999) A ten-year experience using polyurethane-covered breast implants. Aesthetic Plast Surg 23:189–196

    PubMed  Article  Google Scholar 

  39. Vázquez G (2005) Modification of the anatomic silicone gel implant with polyurethane cover. Cir Plast Iberolatinamer 31:193–198

    Google Scholar 

  40. Zimman O, Robles JM, Lee J (1978) The fibrous capsule around mammary implants: An investigation. Aesthetic Plast Surg 2:217

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Jose Abel de la Peña-Salcedo.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

de la Peña-Salcedo, J.A., Soto-Miranda, M.A. & Lopez-Salguero, J.F. Back to the Future: A 15-Year Experience With Polyurethane Foam-Covered Breast Implants Using the Partial-Subfascial Technique. Aesth Plast Surg 36, 331–338 (2012). https://doi.org/10.1007/s00266-011-9826-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00266-011-9826-5

Keywords

  • Capsular contracture
  • Implant rupture
  • Partial-subfascial technique
  • Polyurethane implants
  • Polyurethane-induced cancer