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
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine Ratings, please refer to Table of Contents or online Instructions to Authors www.springer.com/00266.
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References
https://www.isaps.org/wp-content/uploads/2018/10/ISAPS_2017_International_Study_Cosmetic_Procedures.pdf. Accessed February 2019
https://prime-journal.com/realself-releases-2018-aesthetics-trend-report-and-2019-aesthetics-watch-list/?idU=1. Accessed February 2019
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
Vázquez G, Pellón A (2007) Polyurethane-coated silicone gel breast implants used for 18 years. Aesthet Plast Surg 31(4):330–336
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
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
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
Frame J (2016) Commentary on: the modern polyurethane-coated implant in breast augmentation: long-term clinical experience. Aesthet Surg J 36(10):1130–1132
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
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
Stan C, Biggs T (2017) The diagon/gel implant: a preliminary report of 894 cases. Plast Reconstr Surg Glob Open 5(7):e1393
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
Hester T (1988) The polyurethane covered mammary prosthesis: facts and Fiction. Perspect Plast Surg 2:135–164
Parsa F (1988) Displaced inframammary fold after Même breast augmentation. Plast Reconstr Surg 81(4):643–644
Hester T (1990) Diagnosis and treatment of complications occurring with polyurethane-covered breast implants. Perspect Plast Surg 4:105–111
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
Gasperoni C, Salgarello M, Gargani G (1992) Polyurethane-covered mammary implants: a 12-year experience. Ann Plast Surg 29(4):303–308
Brickman M, Parsa N, Parsa F (2004) Late hematoma after breast implantation. Aesthet Plast Surg 28:80–82
Dini G, Ferreira L (2006) Early complication with the use of polyurethane-covered breast implants. Plast Reconstr Surg 117(6):2098–2100
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
Smith M, Durrani A (2011) Aiding the insertion of polyurethane coated breast implants. Ann R Coll Surg Engl 93(7):556
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
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
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
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
Frame J (2017) The waterfall effect in breast augmentation. Gland Surg 6(2):193–202
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)
Hedén P (2009) Mastopexy augmentation with form stable breast implants. Clin Plast Surg 36(1):91–104
Mallucci P, Branford O (2016) Design for natural breast augmentation: the ICE principle. Plast Reconstr Surg 137(6):1728–1737
Mallucci P, Branford OA (2012) Concepts in aesthetic breast dimensions: analysis of the ideal breast. J Plast Reconstr Aesthet Surg 65(1):8–16
LoVerme P, Kelleher J (1986) “Saline float” positioning of the polyurethane-covered breast prosthesis. Plast Reconstr Surg 77(5):845–846
Miro A (2009) Polyurethane-coated silicone breast implants: evaluation of 14 years experience. Rev Bras Cir Plast 24(3):296–303
Georgeu G, Frame J, Frame J Jr (2013) Conical polyurethane implants: an uplifting augmentation. Aesthet Surg J 33:1116–1128
Handel N, Gutierrez J (2006) Long-term safety and efficacy of polyurethane foam-covered breast implants. Aesthet Surg J 26(3):265–274
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
Hoefflin S (1990) Extensive experience with polyurethane breast implants. Plast Reconstr Surg 86(1):166–167
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
Collis Nicholas, Sharpe David T (2000) Recurrence of subglandular breast implant capsular contracture: anterior versus total capsulectomy. Plast Reconstr Surg 106(4):792–797
Hoffman S (1989) Correction of established capsular contractures with polyurethane implants. Aesthet Plast Surg 13:33–40
Ashley F (1972) A further studies on the natural-Y breast prothesis. Plast Reconstr Surg 49(4):414–419
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
Pennisi V (1990) Long-term use of polyurethane breast prostheses: a 14-year experience. Plast Reconstr Surg 86(2):368–371
Batiukov D, Podgaiski V, Ladutko D (2019) Removal of polyurethane implants. Aesthet Plast Surg 43(1):70–75
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)
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)
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])
Walkinson T (1985) Polyurethane-coated Implants. Plast Reconstr Surg 75(6):925–926
Vázquez G (1999) Ten-year experience using polyurethane-covered breast implants. Aesthet Plast Surg 23(3):189–196
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
Hall-Findlay E (2011) Breast implant complication review: double capsules and late seromas. Plast Reconstr Surg 127:56–66
Hall-Findlay E (2011) Reply: breast implant complication review double capsules and late seromas. Plast Reconstr Surg 128(3):818–819
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
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
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
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
Schwartz A, Erich J (1960) Experimental study of polyvinylformal (ivalon) sponge as a substitute for tissue. Plast Reconstr Surg Transpl Bull 25:1–14
Howell D, Delchamps E, Riemer W (1961) Spontaneous mineral deposition in sponge biopsy connective tissue. Proc Soc Exp Biol Med 106:317–319
Pangman W (1965) Compound prosthesis device, US Patent 2,842,775
Pangman W (1958) Compound prosthesis, US Patent 3,189,921
Pangman W (1971) Compound prosthesis, US Patent 3,559,214
Ashley FL (1970) A new type of breast prosthesis. Preliminary report. Plast Reconstr Surg 45(5):421–424
Barr S, Bayat A (2011) Breast implant surface development: perspectives on development and manufacture. Aesthet Surg J 31(1):56–67
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
Capozzi A, Pennisi V (1981) Clinical experience with polyurethane-covered gel-filled mammary prostheses. Plast Reconstr Surg 68(4):512–518
Batich C, Williams J, King R (1989) Toxic hydrolysis product form a biodegradable foam implant. J Biomed Mater Res 23(suppl A3):311–319
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
Chan S, Birdsell D, Gradeen C (1991) Urinary excretion of free toluenediamines in a patient with polyurethane-covered breast implants. Clin Chem 37:2143
Benoit FM (1993) Degradation of polyurethane foams used in the Même breast implant. J Biomed Mater Res 27(10):1341–1348
Quaid J (1989) Method for making open-cell, silicone-elastomer medical implant, US patent 4889744
Yan J, Purkait B (1991) Method of making textured surface prosthesis implants, US patent 5022942
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
Risk Assessment Meeting on Polyurethane-Coated Breast Implants, US Food & Drug Administration, Washington, June 26, 1991
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)
Harris H (1961) Survey of breast implants from the point of view of carcinogenesis. Plast Reconstr Surg Transpl Bull 28:81–83
Dunn K, Hall P, Khoo C (1992) Breast implant materials: sense and safety. Br J Plast Surg 45:315–321
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
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
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
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)
Kulig K (1998) Lifetime risk from polyurethane covered breast implants. Environ Health Perspect 106(11):A526–A527
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
https://www.gov.uk/government/news/suspension-of-devices-manufactured-by-silimed. Accessed July 2019
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
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
Bizjak M, Selmi C, Praprotnik S et al (2015) Silicone implants and lymphoma: the role of inflammation. J Autoimmun 65:64–73
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
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
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
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
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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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DOI: https://doi.org/10.1007/s00266-019-01510-6