BellaGel SmoothFine ® implant is a novel nanotextured silicone breast implant. The objective of this study was to characterize differences of BellaGel SmoothFine ® surfaces with commercial available implant surfaces in terms of texture, topography, and wettability as well as the behavior of capsular contracture. The surface textures of breast implants from two different manufacturers (Hans Biomed and Motiva) were evaluated. The implants utilized in this study were BellaGel Smooth ® , BellaGel Textured ® , BellaGel SmoothFine ® or Motiva SilkSurface ® . The shell textures of these implants were characterized using a scanning electron microscopy, three dimensional confocal laser scanning microscope, and contact angle goniometer. Silicone breast implants were emplaced beneath the panniculus carnosus muscle on the dorsum of Sprague Dawley rats and observed for up to 8 weeks postoperative days. The fibrous capsules around silicone implants were explanted for histological examination. BellaGel SmoothFine ® exhibits a relatively flat, with little or no depth in the texturing, 5.96 ± 0.41 μm surface roughness, and a contact angle of 103.14 ± 2.06 BellGel SmoothFine ® implant resulted in significant decreases in capsule thickness ( P < 0.05) and collagen production ( P < 0.05) at 8 weeks with respect to the BellaGel Smooth ® and BellaGel Textured ® implant groups. Significant ( P < 0.05) decreases in inducible nitric oxide synthase, an inflammation marker, were observed in the BellGel SmoothFine ® . Fibrous tissue formation markers (Vimentin and alpha-smooth muscle actin) were significantly reduced in BellaGel SmoothFine ® surfaces versus BellaGel Smooth ® surfaces ( P < 0.05) or BellaGel Textured ® groups ( P < 0.05). Overall, these findings suggest that the nanotextured BellaGel SmoothFine ® implant is associated with less breast implant derived capsular contracture than other surfaces.
KeywordsSilicone Breast ImplantCapsular ContractureTopographyRoughnessiNOS
Anderson, J.M., Rodriguez, A. and Chang, D.T. (2008) Foreign Body Reaction to Biomaterials. Seminars in Immunology, 20, 86-100. https://doi.org/10.1016/j.smim.2007.11.004
American Society of Plastic Surgeons (2013) Plastic Surgery Statistics Report.
Araco, A., Caruso, R., Araco, F., Overton, J. and Gravant, G. (2009) Capsular Contractures: A Systematic Review. Plastic Reconstructive Surgery, 124, 1808-1819. https://doi.org/10.1097/PRS.0b013e3181bf7f26
Handel, N., Cordray, T., Gutierrez, J., et al. (2006) A Long-Term Study of Outcomes, Complications, and Patient Satisfaction with Breast Implants. Plastic Reconstructive Surgery, 117, 757-767. https://doi.org/10.1097/01.prs.0000201457.00772.1d
Headon, H., Kasem, A. and Mokbel, K. (2015) Capsular Contracture after Breast Augmentation: An Update for Clinical Practice. Archives of Plastic Surgery, 42, 532-543. https://doi.org/10.5999/aps.2015.42.5.532
Rosato, R.M. and Dowden, R.V. (1994) Radiation-Therapy as a Cause of Capsular Contracture. Annals of Plastic Surgery, 32, 342-345. https://doi.org/10.1097/00000637-199404000-00002
Cash, T.F., Duel, L.A. and Perkins, L.L. (2002) Women’s Psychosocial Outcomes of Breast Augmentation with Silicone Gel-Filled Implants: A 2-Year Prospective Study. Plastic and Reconstructive Surgery, 109, 2112-2121. https://doi.org/10.1097/00006534-200205000-00049
Harvey, A.G., Hill, E.W. and Bayat, A. (2013) Designing Implant Surface Topography for Improved Biocompatibility. Expert Review of Medical Devices, 10, 257-267. https://doi.org/10.1586/erd.12.82
Barr, S. and Bayat, A. (2011) Breast Implant Surface Development: Perspectives on Development and Manufacture. Aesthetic Surgery Journal, 31, 56-67. https://doi.org/10.1177/1090820X10390921
Barr, S., Hill, E. and Bayat, A. (2009) Current Implant Surface Technology: An Examination of Their Nanostructure and Their Influence on Fibroblast Alignment and Biocompatibility. Eplasty, 9, e22.
Valencia-Lazcano, A.A., Alonso-Rasgado, T. and Bayat, A. (2013) Characterisation of Breast Implant Surfaces and Correlation with Fibroblast Adhesion. Journal of the Mechanical Behavior of Biomedical Materials, 21, 133-148. https://doi.org/10.1016/j.jmbbm.2013.02.005
Barnsley, G.P., Sigurdson, L.J. and Barnsley, S.E. (2006) Textured Surface Breast Implants in the Prevention of Capsular Contracture among Breast Augmentation Patients: A Meta-Analysis of Randomized Controlled Trials. Plastic and Reconstructive Surgery, 117, 2182-2190. https://doi.org/10.1097/01.prs.0000218184.47372.d5
Wong, C.H., Samuel, M., Tan, B.K., et al. (2006) Capsular Contracture in Subglandular Breast Augmentation with Textured versus Smooth Breast Implants: A Systematic Review. Plastic and Reconstructive Surgery, 118, 1224-1236. https://doi.org/10.1097/01.prs.0000237013.50283.d2
Hall-Findlay, E.J. (2011) Breast Implant Complication Review: Double Capsules and Late Seromas. Plastic and Reconstructive Surgery, 127, 56-66. https://doi.org/10.1097/PRS.0b013e3181fad34d
Doren, E.L., Miranda, R.N., Selber, J.C., et al. (2017) U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plastic and Reconstructive Surgery, 139, 1042-1050. https://doi.org/10.1097/PRS.0000000000003282
Anselme, K. and Bigerelle, M. (2011) Role of Materials Surface Topography on Mammalian Cell Response. International Materials Reviews, 56, 243-266. https://doi.org/10.1179/1743280411Y.0000000001
Flemming, R.G., Murphy, C.J., Abrams, G.A., et al. (1999) Effects of Synthetic Micro- and Nano-Structured Surfaces on Cell Behavior. Biomaterials, 20, 573-588. https://doi.org/10.1016/S0142-9612(98)00209-9
Hajicharalambous, C.S., Lichter, J., Hix, W.T., et al. (2009) Nano- and Sub-Micron Porous Polyelectrolyte Multilayer Assemblies: Biomimetic Surfaces for Human Corneal Epithelial Cells. Biomaterials, 30, 4029-4036. https://doi.org/10.1016/j.biomaterials.2009.03.020
Kulangara, K., Adler, A.F., Wang, H., et al. (2014) The Effect of Substrate Topography on Direct Reprogramming of Fibroblasts to Induced Neurons. Biomaterials, 35, 5327-5336. https://doi.org/10.1016/j.biomaterials.2014.03.034
Nikkhah, M., Edalat, F., Manoucheri, S., et al. (2012) Engineering Microscale Topographies to Control the Cell-Substrate Interface. Biomaterials, 33, 5230-5246. https://doi.org/10.1016/j.biomaterials.2012.03.079
Kyle, D.J., Oikonomou, A., Hill, E., et al. (2015) Development and Functional Evaluation of Biomimetic Silicone Surfaces with Hierarchical Micro/Nano-Topographical Features Demonstrates Favourable in Vitro Foreign Body Response of Breast-Derived Fibroblasts. Biomaterials, 52, 88-102. https://doi.org/10.1016/j.biomaterials.2015.02.003
Langer, R. and Tirrell, D.A. (2004) Designing Materials for Biology and Medicine. Nature, 428, 487-492. https://doi.org/10.1038/nature02388
Han, J., Jeong, J.H. and Bang, S.H. (2019) BellaGel Breast Implant: 4-Year Results of a Prospective Cohort Study. Journal of Plastic Surgery and Hand Surgery, 53, 232-239. https://doi.org/10.1080/2000656X.2019.1583572
Barr, S., Hill, E.W. and Bayat, A. (2017) Functional Biocompatibility Testing of Silicone Breast Implants and a Novel Classification System Based on Surface Roughness. Journal of the Mechanical Behavior of Biomedical Materials, 75, 75-81. https://doi.org/10.1016/j.jmbbm.2017.06.030
Munhoz, A.M., di Pompeo, F.S. and De Mezerville, R. (2017) Nanotechnology, Nanosurfaces and Silicone Gel Breast Implants: Current Aspects. Case Reports in Plastic Surgery and Hand Surgery, 4, 99-113. https://doi.org/10.1080/23320885.2017.1407658
Vieira, V.J., d’Acampora, A.J., Marcos, A.B.W., et al. (2010) Vascular Endothelial Growth Factor Overexpression Positively Modulates the Characteristics of Periprosthetic Tissue of Polyurethane-Coated Silicone Breast Implant in Rats. Plastic Reconstructive Surgery, 126, 1899-1910. https://doi.org/10.1097/PRS.0b013e3181f446d5
Berry, M.G. and Davies, D.M. (2010) Breast Augmentation: Part I—A Review of the Silicone Prosthesis. Journal of Plastic, Reconstructive & Aesthetic Surgery, 63, 1761-1768. https://doi.org/10.1016/j.bjps.2009.07.047
Brohim, R.M., Foresman, P.A., Hildebrandt, P.K., et al. (1992) Early Tissue Reaction to Textured Breast Implant Surfaces. Annals of Plastic Surgery, 28, 354-362. https://doi.org/10.1097/00000637-199204000-00010
Danino, M.A., Efanov, J.I., Dimitropoulos, G., et al. (2018) Capsular Biofilm Formation at the Interface of Textured Expanders and Human Acellular Dermal Matrix: A Comparative Scanning Electron Microscopy Study. Plastic Reconstructive Surgery, 141, 919-928. https://doi.org/10.1097/PRS.0000000000004216
Snow, J., Harasaki, H., Kasick, J., et al. (1981) Promising Results with a New Textured Surface Intrathoracic Variable Volume Device for LVAS. Transactions—ASAIO American Society for Artificial Internal Organs, 27, 485-489.
Clugston, P.A., Perry, L.C., Hammond, D.C. and Maxwell, G.P. (1994) A Rat Model for Capsular Contracture: The Effects of Surface Texturing. Annals of Plastic Surgery, 33, 595-599. https://doi.org/10.1097/00000637-199412000-00005
Derby, B.M. and Codner, M.A. (2015) Textured Silicone Breast Implant Use in Primary Augmentation: Core Data Update and Review. Plastic Reconstructive Surgery, 135, 113-124. https://doi.org/10.1097/PRS.0000000000000832
Hakelius, L. and Ohlsen, L. (1997) Tendency to Capsular Contracture around Smooth and Textured Gel-Filled Silicone Mammary Implants: A 5-Year Follow-Up. Plastic Reconstructive Surgery, 100, 1566-1569. https://doi.org/10.1097/00006534-199711000-00030
Coleman, D.J., Sharpe, D.T., Naylor, I.L., et al. (1993) The Role of the Contractile Fibroblast in the Capsules around Tissue Expanders and Implants. British Journal of Plastic Surgery, 46, 547-556. https://doi.org/10.1016/0007-1226(93)90104-J
Malata, C.M., Feldberg, L., Coleman, D.J., et al. (1997) Textured or Smooth Implants for Breast Augmentation? Three Year Follow-Up of a Prospective Randomised Controlled Trial. British Journal of Plastic Surgery, 50, 99-105. https://doi.org/10.1016/S0007-1226(97)91320-5
Collis, N., Coleman, D., Foo, I.T.H., et al. (2000) Ten-Year Review of a Prospective Randomized Controlled Trial of Textured versus Smooth Subglandular Silicone Gel Breast Implants. Plastic Reconstructive Surgery, 106, 786-791. https://doi.org/10.1097/00006534-200009020-00005
Burkhardt, B.R. and Demas, C.P. (1994) The Effect of Siltex Texturing and Povidone-Iodine Irrigation on Capsular Contracture around Saline Inflatable Breast Implants. Plastic Reconstructive Surgery, 93, 123-128. https://doi.org/10.1097/00006534-199401000-00018
Burkhardt, B.R. and Eades, E. (1995) The Effect of Biocell Texturing and Povidone-Iodine Irrigation on Capsular Contracture around Saline-Inflatable Breast Implants. Plastic Reconstructive Surgery, 96, 1317-1325. https://doi.org/10.1097/00006534-199511000-00013
Fagrell, D., Berggren, A. and Tarpila, E. (2001) Capsular Contracture around Saline-Filled Fine Textured and Smooth Mammary Implants: A Prospective 7.5-Year Follow-Up. Plastic Reconstructive Surgery, 108, 2108-2112. https://doi.org/10.1097/00006534-200112000-00047
Ibrahim, M.M., Bond, J., Bergeron, A., et al. (2014) A Novel Immune Competent Murine Hypertrophic Scar Contracture Model: A Tool to Elucidate Disease Mechanism and Develop New Therapies. Wound Repair and Regeneration, 22, 755-764. https://doi.org/10.1111/wrr.12238
Orciani, M., Lazzarini, R., Scartozzi, M., et al. (2013) The Response of Breast Cancer Cells to Mesenchymal Stem Cells: A Possible Role of Inflammation by Breast Implants. Plastic Reconstructive Surgery, 132, 899e-910e. https://doi.org/10.1097/01.prs.0000434401.98939.60
Leung, T.M., Fung, M.L., Liong, E.C., et al. (2011) Role of Nitric Oxide in the Regulation of Fibrogenic Factors in Experimental Liver Fibrosis in Mice. Histology and Histopathology, 26, 201-211.
Fielding, C.A., Jones, G.W., McLoughlin, R.M., et al. (2014) Interleukin-6 Signaling Drives Fibrosis in Unresolved Inflammation. Immunity, 40, 40-50. https://doi.org/10.1016/j.immuni.2013.10.022
Rudoph, R., Guber, S., Suzaki, M., et al. (1977) The Life Cycle of the Myofibroblast. Surgery, Gynecology & Obstetrics, 145, 389.