Types of Errors Made During Breast Augmentation with Polyurethane Implants: A Systematic Review

Aesthetic Plastic Surgery volume 44, pages70–79(2020)Cite this article

Abstract

Background

Implementation of polyurethane-covered (PU) implants into practice requires a reassessment of the experience and a learning curve period. Occasional publications describe a few difficulties in this regard. However, there are no publications covering the spectrum of errors. The absence of definite information and contradictory findings makes the learning curve longer leading to many unsatisfactory results.

Materials and Methods

The systematization is based on the 12 years of experience with over 1000 patients and previously published data. A literature review was conducted using PUBMED with the following keywords: polyurethane or foam or sponge and breast and implant. A total of 285 articles were found (last accessed 08/13/2019). All articles concerning polyurethane implants were studied along with any articles found describing the surgical techniques applied to them. Additional references found in the above-mentioned articles were also included in the study.

Results

All errors can be divided into planning errors, errors in pocket development and surface-dependent errors, for which the polyurethane surface is the main reason. Surface-dependent errors include the errors connected to positioning and biointegration. The possible causes of late seroma with PU implants are discussed.

Conclusions

The polyurethane surface should not be considered textured in the clinical point of view. Previous experience with non-PU implants cannot be transferred to PU implants. The learning curve is unavoidable. The systematization of errors with PU implants facilitates a decision-making process during the primary and secondary surgery and lowers the risk of the unsatisfactory results.

Level of Evidence IV

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References

  1. 1.

    https://www.isaps.org/wp-content/uploads/2018/10/ISAPS_2017_International_Study_Cosmetic_Procedures.pdf. Accessed February 2019

  2. 2.

    https://prime-journal.com/realself-releases-2018-aesthetics-trend-report-and-2019-aesthetics-watch-list/?idU=1. Accessed February 2019

  3. 3.

    FDA update on the safety of silicone gel-filled breast implants. http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf. Accessed June 2019

  4. 4.

    Vázquez G, Pellón A (2007) Polyurethane-coated silicone gel breast implants used for 18 years. Aesthet Plast Surg 31(4):330–336

    Article  Google Scholar 

  5. 5.

    Fleming D, Handel M, Gutierrez J (2012) Polyurethane foam covered breast implants. In: Peters W, Brandon H, Jerina KL, Wolf C, Young VL (eds) Biomaterials in plastic surgery. Elsevier, New York, pp 96–120

    Google Scholar 

  6. 6.

    Castel N, Soon-Sutton T, Deptula P, Flaherty A, Parsa F (2015) Polyurethane-coated breast implants revisited: a 30-year follow-up. Arch Plast Surg 42(2):186–193

    PubMed  PubMed Central  Article  Google Scholar 

  7. 7.

    Duxbury P, Harvey J (2016) Systematic review of the effectiveness of polyurethane-coated compared with textured silicone implants in breast surgery. J Plast Reconstr Aesthet Surg 69(4):452–460

    PubMed  Article  PubMed Central  Google Scholar 

  8. 8.

    Frame J (2016) Commentary on: the modern polyurethane-coated implant in breast augmentation: long-term clinical experience. Aesthet Surg J 36(10):1130–1132

    PubMed  Article  PubMed Central  Google Scholar 

  9. 9.

    Pompei S, Evangelidou D, Arelli F, Ferrante G (2016) The modern polyurethane-coated implant in breast augmentation: long-term clinical experience. Aesthet Surg J 36(10):1124–1129

    PubMed  Article  PubMed Central  Google Scholar 

  10. 10.

    Pompei S, Arelli F, Labardi L, Marcasciano F, Evangelidou D, Ferrante G (2017) Polyurethane implants in 2-stage breast reconstruction: 9-year clinical experience. Aesthet Surg J 37(2):171–176

    PubMed  Article  Google Scholar 

  11. 11.

    Stan C, Biggs T (2017) The diagon/gel implant: a preliminary report of 894 cases. Plast Reconstr Surg Glob Open 5(7):e1393

    PubMed  PubMed Central  Article  Google Scholar 

  12. 12.

    Berrino P, Galli A, Rainero M, Santi P (1986) Long-lasting complications with the use of polyurethane-covered breast implants. Br J Plast Surg 39(4):549–553

    CAS  PubMed  Article  Google Scholar 

  13. 13.

    Hester T (1988) The polyurethane covered mammary prosthesis: facts and Fiction. Perspect Plast Surg 2:135–164

    Google Scholar 

  14. 14.

    Parsa F (1988) Displaced inframammary fold after Même breast augmentation. Plast Reconstr Surg 81(4):643–644

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  15. 15.

    Hester T (1990) Diagnosis and treatment of complications occurring with polyurethane-covered breast implants. Perspect Plast Surg 4:105–111

    Google Scholar 

  16. 16.

    Cohney B, Cohney T, Hearne V (1991) Nineteen years’ experience with polyurethane foam-covered mammary prosthesis: a preliminary report. Ann Plast Surg 27(1):27–30

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  17. 17.

    Gasperoni C, Salgarello M, Gargani G (1992) Polyurethane-covered mammary implants: a 12-year experience. Ann Plast Surg 29(4):303–308

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  18. 18.

    Brickman M, Parsa N, Parsa F (2004) Late hematoma after breast implantation. Aesthet Plast Surg 28:80–82

    Article  Google Scholar 

  19. 19.

    Dini G, Ferreira L (2006) Early complication with the use of polyurethane-covered breast implants. Plast Reconstr Surg 117(6):2098–2100

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  20. 20.

    Prado A, Andrades P, Benitez S (2006) A word of caution on the explantation of polyurethane breast implants. Plast Reconstr Surg 117(5):1655–1657

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  21. 21.

    Smith M, Durrani A (2011) Aiding the insertion of polyurethane coated breast implants. Ann R Coll Surg Engl 93(7):556

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  22. 22.

    Dini M, Giordano V, Quattrini L, Mori A, Napoli S (2011) Double capsules: our experience with polyurethane-coated silicone breast implants. Plast Reconstr Surg 128(3):819–820

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  23. 23.

    Rancati A, Soderini A, Dorr J, Gercovich G, Tessari L, Gonzalez E (2013) One-step breast reconstruction with polyurethane-covered implants after skin-sparing mastectomy. J Plast Reconstr Aesthet Surg 66(12):1671–1675

    PubMed  Article  PubMed Central  Google Scholar 

  24. 24.

    Castello M, Han S, Silvestri A et al (2014) A simple method to inset and position polyurethane-covered breast implants. Aesthet Plast Surg 38:365–368

    Article  Google Scholar 

  25. 25.

    Scarpa C, Borso G, Vindigni V, Bassetto F (2015) Polyurethane foam-covered breast implants: a justified choice? Eur Rev Med Pharmacol Sci 19:1600–1606

    CAS  PubMed  Google Scholar 

  26. 26.

    Frame J (2017) The waterfall effect in breast augmentation. Gland Surg 6(2):193–202

    PubMed  PubMed Central  Article  Google Scholar 

  27. 27.

    Tebbetts J (2002) A system for breast implant selection based on patient tissue characteristics and implant-soft tissue dynamics. Plast Reconstr Surg 109(4):1396–1409 (discussion 1410-5)

    PubMed  Article  Google Scholar 

  28. 28.

    Hedén P (2009) Mastopexy augmentation with form stable breast implants. Clin Plast Surg 36(1):91–104

    PubMed  Article  Google Scholar 

  29. 29.

    Mallucci P, Branford O (2016) Design for natural breast augmentation: the ICE principle. Plast Reconstr Surg 137(6):1728–1737

    CAS  PubMed  Article  Google Scholar 

  30. 30.

    Mallucci P, Branford OA (2012) Concepts in aesthetic breast dimensions: analysis of the ideal breast. J Plast Reconstr Aesthet Surg 65(1):8–16

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  31. 31.

    LoVerme P, Kelleher J (1986) “Saline float” positioning of the polyurethane-covered breast prosthesis. Plast Reconstr Surg 77(5):845–846

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  32. 32.

    Miro A (2009) Polyurethane-coated silicone breast implants: evaluation of 14 years experience. Rev Bras Cir Plast 24(3):296–303

    Google Scholar 

  33. 33.

    Georgeu G, Frame J, Frame J Jr (2013) Conical polyurethane implants: an uplifting augmentation. Aesthet Surg J 33:1116–1128

    PubMed  Article  PubMed Central  Google Scholar 

  34. 34.

    Handel N, Gutierrez J (2006) Long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthet Surg J 26(3):265–274

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  35. 35.

    Brunnert KE (2015) The micropolyurethane foam-coated Diagon/Gel®4Two implant in aesthetic and reconstructive breast surgery – 3-year results of an ongoing study. GMS Interdiscip Plast Reconstr Surg DGPW 4: Doc20

  36. 36.

    Hoefflin S (1990) Extensive experience with polyurethane breast implants. Plast Reconstr Surg 86(1):166–167

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  37. 37.

    Melmed E (1990) Treatment of breast contractures with open capsulotomy and replacement of gel prostheses with polyurethane-covered implants. Plast Reconstr Surg 86(2):270–274

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  38. 38.

    Collis Nicholas, Sharpe David T (2000) Recurrence of subglandular breast implant capsular contracture: anterior versus total capsulectomy. Plast Reconstr Surg 106(4):792–797

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  39. 39.

    Hoffman S (1989) Correction of established capsular contractures with polyurethane implants. Aesthet Plast Surg 13:33–40

    CAS  Article  Google Scholar 

  40. 40.

    Ashley F (1972) A further studies on the natural-Y breast prothesis. Plast Reconstr Surg 49(4):414–419

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  41. 41.

    Artz S, Dinner M, Foglietti M (1991) Breast reconstruction utilizing subcutaneous tissue expansion followed by polyurethane-covered silicone implants: a 6-year experience. Plast Reconstr Surg 88(4):635–639

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  42. 42.

    Pennisi V (1990) Long-term use of polyurethane breast prostheses: a 14-year experience. Plast Reconstr Surg 86(2):368–371

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  43. 43.

    Batiukov D, Podgaiski V, Ladutko D (2019) Removal of polyurethane implants. Aesthet Plast Surg 43(1):70–75

    CAS  Article  Google Scholar 

  44. 44.

    Tebbetts J (2002) Achieving a predictable 24-hour return to normal activities after breast augmentation: part I. Refining practices by using motion and time study principles. Plast Reconstr Surg 109(1):273–290 (discussion 291-2)

    PubMed  Article  PubMed Central  Google Scholar 

  45. 45.

    Tebbetts J (2002) Achieving a predictable 24-hour return to normal activities after breast augmentation: part II. Patient preparation, refined surgical techniques, and instrumentation. Plast Reconstr Surg 109(1):293–305 (discussion 306-7)

    PubMed  Article  PubMed Central  Google Scholar 

  46. 46.

    Schlesinger S (1989) The use of surgilube for inserting the polyurethane-covered gel-filled mammary implant. Plast Reconstr Surg 84(4):703 (Comment on Displaced inframammary fold after Même breast augmentation. [Plast Reconstr Surg. 1988])

    CAS  PubMed  PubMed Central  Google Scholar 

  47. 47.

    Walkinson T (1985) Polyurethane-coated Implants. Plast Reconstr Surg 75(6):925–926

    Article  Google Scholar 

  48. 48.

    Vázquez G (1999) Ten-year experience using polyurethane-covered breast implants. Aesthet Plast Surg 23(3):189–196

    Article  Google Scholar 

  49. 49.

    de la Penã-Salcedo J, Soto-Miranda M, Lopez-Salguero J (2012) Back to the future: a 15-year experience with polyurethane foam covered breast implants using the partial-subfascial technique. Aesthet Plast Surg 36(2):331e8

    Google Scholar 

  50. 50.

    Hall-Findlay E (2011) Breast implant complication review: double capsules and late seromas. Plast Reconstr Surg 127:56–66

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  51. 51.

    Hall-Findlay E (2011) Reply: breast implant complication review double capsules and late seromas. Plast Reconstr Surg 128(3):818–819

    CAS  Article  Google Scholar 

  52. 52.

    Sforza M (2018) Breast implants associated ALCL (BIAALCL): a personal overview for patients. J Surg Open Access. https://doi.org/10.16966/2470-0991.176

    Article  Google Scholar 

  53. 53.

    Grindlay J, Clagett O (1949) A plastic sponge prosthesis for use after pneumonectomy; preliminary report of an experimental study. In: Proceedings of the staff meet mayo clinic 12, vol 24, no 21, p 538

  54. 54.

    Pangman W 2nd, Wallace R, Hills B (1955) The use of plastic prosthesis in breast plastic and other soft tissue surgery. West J Surg Obstet Gynecol 63(8):503–512

    PubMed  Google Scholar 

  55. 55.

    Edgerton M, McClary A (1958) Augmentation mammaplasty; psychiatric implicationsand surgical indications; (with special reference to use of the polyvinyl alcohol sponge ivalon). Plast Reconstr Surg Transpl Bull 21(4):279–305

    CAS  Article  Google Scholar 

  56. 56.

    Schwartz A, Erich J (1960) Experimental study of polyvinylformal (ivalon) sponge as a substitute for tissue. Plast Reconstr Surg Transpl Bull 25:1–14

    CAS  Article  Google Scholar 

  57. 57.

    Howell D, Delchamps E, Riemer W (1961) Spontaneous mineral deposition in sponge biopsy connective tissue. Proc Soc Exp Biol Med 106:317–319

    CAS  PubMed  Article  Google Scholar 

  58. 58.

    Pangman W (1965) Compound prosthesis device, US Patent 2,842,775

  59. 59.

    Pangman W (1958) Compound prosthesis, US Patent 3,189,921

  60. 60.

    Pangman W (1971) Compound prosthesis, US Patent 3,559,214

  61. 61.

    Ashley FL (1970) A new type of breast prosthesis. Preliminary report. Plast Reconstr Surg 45(5):421–424

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  62. 62.

    Barr S, Bayat A (2011) Breast implant surface development: perspectives on development and manufacture. Aesthet Surg J 31(1):56–67

    PubMed  Article  Google Scholar 

  63. 63.

    Cohney B, Cohney T, Hearne V (1992) Augmentation mammaplasty–a further review of 20 years using the polyurethane-covered prosthesis. J Long Term Eff Med Implants 1:269–279

    CAS  PubMed  PubMed Central  Google Scholar 

  64. 64.

    Capozzi A, Pennisi V (1981) Clinical experience with polyurethane-covered gel-filled mammary prostheses. Plast Reconstr Surg 68(4):512–518

    CAS  PubMed  Article  Google Scholar 

  65. 65.

    Batich C, Williams J, King R (1989) Toxic hydrolysis product form a biodegradable foam implant. J Biomed Mater Res 23(suppl A3):311–319

    CAS  PubMed  Article  Google Scholar 

  66. 66.

    Chan S, Birdsell D, Gradeen C (1991) Detection of toluenediamines in the urine of a patient with polyurethane-covered breast implants. Clin Chem 37:756

    CAS  PubMed  Article  Google Scholar 

  67. 67.

    Chan S, Birdsell D, Gradeen C (1991) Urinary excretion of free toluenediamines in a patient with polyurethane-covered breast implants. Clin Chem 37:2143

    CAS  PubMed  Article  Google Scholar 

  68. 68.

    Benoit FM (1993) Degradation of polyurethane foams used in the Même breast implant. J Biomed Mater Res 27(10):1341–1348

    CAS  PubMed  Article  Google Scholar 

  69. 69.

    Quaid J (1989) Method for making open-cell, silicone-elastomer medical implant, US patent 4889744

  70. 70.

    Yan J, Purkait B (1991) Method of making textured surface prosthesis implants, US patent 5022942

  71. 71.

    Burkhardt B, Eades E (1995) The effect of biocell texturing and povidone-iodine irrigation on capsular contracture around saline-inflatable breast implants. Plast Reconstr Surg 96:1317–1325

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  72. 72.

    Risk Assessment Meeting on Polyurethane-Coated Breast Implants, US Food & Drug Administration, Washington, June 26, 1991

  73. 73.

    Canadian Medical Association (1991) Safety of polyurethane-covered breast implants expert panel on the safety of polyurethane-covered breast implants. CMAJ 145(9):1125–1132 (Review. English, French)

    Google Scholar 

  74. 74.

    Harris H (1961) Survey of breast implants from the point of view of carcinogenesis. Plast Reconstr Surg Transpl Bull 28:81–83

    CAS  Article  Google Scholar 

  75. 75.

    Dunn K, Hall P, Khoo C (1992) Breast implant materials: sense and safety. Br J Plast Surg 45:315–321

    CAS  PubMed  Article  PubMed Central  Google Scholar 

  76. 76.

    Daka J, Chawla A (1993) Release of chemicals from polyurethane foam in the Même breast implant. Biomater Artif Cells Immobil Biotechnol 21(1):23–46

    CAS  Google Scholar 

  77. 77.

    Food and Drug Administration (1995) Update: Study of TDA Released from Polyurethane Foam-Covered Breast Implants. Rockville, Md: U.S. Department of Health and Human Services; Jun 27, 1995. POLYURETHANE/toxicology/general

  78. 78.

    Hester T, Ford N, Gale P et al (1997) Measurement of 2,4-toluenediamine in the urine and serum samples from women with Même or Replicon breast implants. Plast Reconstr Surg 100:1291–1298

    PubMed  Article  PubMed Central  Google Scholar 

  79. 79.

    Bondurant S, Ernster V, Herdman R (eds) Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants. National Academies Press (US), Washington (DC)

  80. 80.

    Kulig K (1998) Lifetime risk from polyurethane covered breast implants. Environ Health Perspect 106(11):A526–A527

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  81. 81.

    Luu H, Hutter J, Bushar H (1998) A physiologically based pharmacokinetic model for 2,4-toluenediamine leached from polyurethane foam-covered breast implants. Environ Health Perspect 106(7):393–400

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  82. 82.

    https://www.gov.uk/government/news/suspension-of-devices-manufactured-by-silimed. Accessed July 2019

  83. 83.

    ISO International Organization for Standardization. ISO 1460: 2018—Non-active surgical implants—Mammary implants—Particular requirements. https://www.iso.org/standard/63973.html. Accessed January 7, 2019

  84. 84.

    Hamdi M (2019) Association between breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) risk and polyurethane breast implants: clinical evidence and european perspective. Aesthet Surg J 39(Supplement_1):S49–S54

    PubMed  Article  PubMed Central  Google Scholar 

  85. 85.

    Bizjak M, Selmi C, Praprotnik S et al (2015) Silicone implants and lymphoma: the role of inflammation. J Autoimmun 65:64–73

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  86. 86.

    Hu H, Jacombs A, Vickery K, Merten S, Pennington D, Deva A (2015) Chronic biofilm infection in breast implants is associated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma. Plast Reconstr Surg 135(2):319–329

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  87. 87.

    Kadin M, Deva A, Xu H et al (2016) Biomarkers provide clues o early events in the pathogenesis of breast implant associated anaplastic large cell lymphoma. Aesthet Surg J 36(7):773–781

    PubMed  Article  PubMed Central  Google Scholar 

  88. 88.

    Atlan M, Nuti G, Wang H, Decker S, Perry T (2018) Breast implant surface texture impacts host tissue response. J Mech Behav Biomed Mater 88:377–385

    PubMed  Article  PubMed Central  Google Scholar 

  89. 89.

    Jacombs A, Tahir S, Hu H et al (2014) In vitro and in vivo investigation of the influence of implant surface on the formation of bacterial biofilm in mammary implants. Plast Reconstr Surg 133(4):471e–480e

    CAS  PubMed  Article  PubMed Central  Google Scholar 

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Affiliations

  1. Medical Center “Antes Med”, Krasnoarmejskaja Str. 32, Minsk, 220030, Belarus

    D. Batiukov & D. Ladutko

  2. Belorussian Medical Academy of Postgraduate Education, Brovki 3, b. 3, Minsk, 220013, Belarus

    V. Podgaiski

  3. Department of Microsurgery, Minsk Regional Hospital, 223040, Lesnoe, Minsk Region, Belarus

    D. Ladutko

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Correspondence to D. Batiukov.

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D Batiukov received a speaker honorarium from POLYTECH Health & Aesthetics. V. Podgaiski and D. Ladutko declare that they have no conflict of interest.

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Video 1. Positioning error. Both implants are bended anteriorly in this patient (MP4 14430 kb)

Video 2. Positioning error (implant-tissue interactions). Double bubble formation (MP4 19988 kb)

Video 3. Biointegration error. Only the second sheeting of PU implant remained attached to the tissues in the long term (MP4 26360 kb)

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Batiukov, D., Podgaiski, V. & Ladutko, D. Types of Errors Made During Breast Augmentation with Polyurethane Implants: A Systematic Review. Aesth Plast Surg 44, 70–79 (2020). https://doi.org/10.1007/s00266-019-01510-6

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Keywords

  • Polyurethane implants
  • Breast augmentation
  • Secondary breast surgery
  • High-riding implants
  • Implant malposition
  • Bottoming out