Types of Errors Made During Breast Augmentation with Polyurethane Implants: A Systematic Review
- 100 Downloads
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.
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.
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.
KeywordsPolyurethane implants Breast augmentation Secondary breast surgery High-riding implants Implant malposition Bottoming out
Compliance with Ethical Standards
Conflict of interest
D Batiukov received a speaker honorarium from POLYTECH Health & Aesthetics. V. Podgaiski and D. Ladutko declare that they have no conflict of interest.
Human and Animal Rights
This article does not contain any studies with human participants or animals performed by any of the authors.
For this type of study, formal consent is not required.
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)
- 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
- 13.Hester T (1988) The polyurethane covered mammary prosthesis: facts and Fiction. Perspect Plast Surg 2:135–164Google Scholar
- 15.Hester T (1990) Diagnosis and treatment of complications occurring with polyurethane-covered breast implants. Perspect Plast Surg 4:105–111Google Scholar
- 32.Miro A (2009) Polyurethane-coated silicone breast implants: evaluation of 14 years experience. Rev Bras Cir Plast 24(3):296–303Google Scholar
- 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: Doc20Google Scholar
- 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):331e8Google Scholar
- 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 538Google Scholar
- 58.Pangman W (1965) Compound prosthesis device, US Patent 2,842,775Google Scholar
- 59.Pangman W (1958) Compound prosthesis, US Patent 3,189,921Google Scholar
- 60.Pangman W (1971) Compound prosthesis, US Patent 3,559,214Google Scholar
- 69.Quaid J (1989) Method for making open-cell, silicone-elastomer medical implant, US patent 4889744Google Scholar
- 70.Yan J, Purkait B (1991) Method of making textured surface prosthesis implants, US patent 5022942Google Scholar
- 72.Risk Assessment Meeting on Polyurethane-Coated Breast Implants, US Food & Drug Administration, Washington, June 26, 1991Google Scholar
- 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
- 76.Daka J, Chawla A (1993) Release of chemicals from polyurethane foam in the Même breast implant. Biomater Artif Cells Immobil Biotechnol 21(1):23–46Google Scholar
- 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/generalGoogle Scholar
- 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)Google Scholar
- 82.https://www.gov.uk/government/news/suspension-of-devices-manufactured-by-silimed. Accessed July 2019
- 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
- 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):319–329PubMedPubMedCentralCrossRefGoogle Scholar