Jun 16;9:e22. PubMed PMID: 19606207. PubMed Central PMCID: PMC2698670. Epub 2009/07/17. eng.

98. Abramo AC, De Oliveira VR, Ledo-Silva MC, De Oliveira EL. How texture-inducing contraction vectors affect the fibrous capsule shrinkage around breasts implants? Aesthetic plastic surgery. 2010 Oct;34(5):555-60. PubMed PMID: 20354696. Epub 2010/04/01. eng.

99. Barone FE, Perry L, Keller T, Maxwell GP. The Biomechanical and Histopathologic Effects of Surface Texturing with Silicone and Polyurethane in Tissue Implantation and Expansion. Plastic and reconstructive surgery. 1992;90(1):77-86. PubMed PMID: 00006534-199207000-00012.

100. Sforza M, Zaccheddu R, Alleruzzo A, Seno A, Mileto D, Paganelli A, et al. Preliminary 3-Year Evaluation of Experience With SilkSurface and VelvetSurface Motiva Silicone Breast Implants: A Single-Center Experience With 5813 Consecutive Breast Augmentation Cases. Aesthetic surgery journal. 2017.

101. Cranin AN. Handbook of biomaterials evaluation. Scientific, technical and clinical testing of Implant Materials. Andreas F. von Recum, Editor, New York, 1986, MacMillan. With a forward by Solomon Pollack and contributions by 61 authors and 10 section editors. Index of 14 pp. $120.00. Journal of Biomedical Materials Research. 1987;21(9):1167-8.

102. Henderson PW, Nash D, Laskowski M, Grant RT. Objective Comparison of Commercially Available Breast Implant Devices. Aesthetic plastic surgery. 2015 Oct;39(5):724-32. PubMed PMID: 26206500. Epub 2015/07/25. eng.

103. Maxwell GP, Brown MH, Oefelein MG, Kaplan HM, Heden P. Clinical considerations regarding the risks and benefits of textured surface implants and double capsule. Plastic and reconstructive surgery. 2011 Aug;128(2):593-5. PubMed PMID: 21788865. Epub 2011/07/27. eng.

104. Goel MK, Khanna P, Kishore J. Understanding survival analysis: Kaplan-Meier estimate. International journal of Ayurveda research. 2010 Oct-Dec;1(4):274-8. PubMed PMID: 21455458.

105. Barnsley GP, Sigurdson LJ, Barnsley SE. 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. 2006 Jun;117(7):2182-90. PubMed PMID: 16772915. Epub 2006/06/15. eng.

106. Wong CH, Samuel M, Tan BK, Song C. Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: a systematic review. Plastic and reconstructive surgery. 2006 Oct;118(5):1224-36. PubMed PMID: 17016195. Epub 2006/10/04. eng.

107. Liu X, Zhou L, Pan F, Gao Y, Yuan X, Fan D. Comparison of the postoperative incidence rate of capsular contracture among different breast implants: a cumulative meta-analysis. PloS one. 2015;10(2):e0116071. PubMed PMID: 25680100. PubMed Central PMCID: PMC4332657. Epub 2015/02/14. eng.

108. Spear SL, Murphy DK. Natrelle round silicone breast implants: Core Study results at 10 years. Plastic and reconstructive surgery. 2014 Jun;133(6):1354-61. PubMed PMID: 24867717. PubMed Central PMCID: PMC4819531. Epub 2014/05/29. eng.

109. Spear SL, Murphy DK, Slicton A, Walker PS. Inamed silicone breast implant core study results at 6 years. Plastic and reconstructive surgery. 2007 Dec;120(7 Suppl 1):8S-16S; discussion 7S-8S. PubMed PMID: 18090808. Epub 2007/12/27. eng.

110. Taylor CR, Siddiqi IN, Brody GS. Anaplastic large cell lymphoma occurring in association with breast implants: review of pathologic and immunohistochemical features in 103 cases. Applied Immunohistochemistry & Molecular Morphology. 2013;21(1):13-20.

111. Roden AC, Macon WR, Keeney GL, Myers JL, Feldman AL, Dogan A. Seroma-associated primary anaplastic large-cell lymphoma adjacent to breast implants: an indolent T-cell lymphoproliferative disorder. Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc. 2008 Apr;21(4):455-63. PubMed PMID: 18223553. Epub 2008/01/29. eng.

112. Story SK, Schowalter MK, Geskin LJ. Breast implant-associated ALCL: a unique entity in the spectrum of CD30+ lymphoproliferative disorders. The oncologist. 2013;18(3):301-7. PubMed PMID: 23429741. PubMed Central PMCID: PMC3607527. Epub 2013/02/23. eng.
113. Talmadge JE, Donkor M, Scholar E. Inflammatory cell infiltration of tumors: Jekyll or Hyde. Cancer metastasis reviews. 2007 Dec;26(3-4):373-400. PubMed PMID: 17717638. Epub 2007/08/25. eng.

114. Burg G, Kempf W, Haeffner A, Dobbeling U, Nestle FO, Boni R, et al. From inflammation to neoplasia: new concepts in the pathogenesis of cutaneous lymphomas. Recent results in cancer research Fortschritte der Krebsforschung Progres dans les recherches sur le cancer. 2002;160:271-80. PubMed PMID: 12079224. Epub 2002/06/25. eng.

115. Meresse B, Ripoche J, Heyman M, Cerf-Bensussan N. Celiac disease: from oral tolerance to intestinal inflammation, autoimmunity and lymphomagenesis. Mucosal immunology. 2009 Jan;2(1):8-23. PubMed PMID: 19079330. Epub 2008/12/17. eng.

116. Pennock ND, White JT, Cross EW, Cheney EE, Tamburini BA, Kedl RM. T cell responses: naive to memory and everything in between. Advances in physiology education. 2013 Dec;37(4):273-83. PubMed PMID: 24292902. PubMed Central PMCID: PMC4089090. Epub 2013/12/03. eng.

117. Walker JN, Pinkner CL, Pinkner JS, Hultgren SJ, Myckatyn TM. The Detection of Bacteria and Matrix Proteins on Clinically Benign and Pathologic Implants. Plastic and Reconstructive Surgery-Global Open. 2019.

118. Myckatyn TM, Parikh RP. Discussion: Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk. Plastic and reconstructive surgery. 2017 Oct;140(4):655-8. PubMed PMID: 28953712. Epub 2017/09/28. eng.

119. Prantl L, Schreml S, Fichtner-Feigl S, Poppl N, Eisenmann-Klein M, Schwarze H, et al. Clinical and morphological conditions in capsular contracture formed around silicone breast implants. Plastic and reconstructive surgery. 2007 Jul;120(1):275-84. PubMed PMID: 17572576. Epub 2007/06/19. eng.

120. Hall-Findlay EJ. Breast implant complication review: double capsules and late seromas. Plastic and reconstructive surgery. 2011 Jan;127(1):56-66. PubMed PMID: 21200201. Epub 2011/01/05. eng.

121. Wu C, Cipriano J, Osgood G, Jr., Tepper D, Siddiqui A. Human acellular dermal matrix (AlloDerm(R)) dimensional changes and stretching in tissue expander/implant breast reconstruction. Journal of plastic, reconstructive & aesthetic surgery : JPRAS. 2013 Oct;66(10):1376-81. PubMed PMID: 23790562. Epub 2013/06/25. eng.

122. Lilla JA, Vistnes LM. Long-term study of reactions to various silicone breast implants in rabbits. Plastic and reconstructive surgery. 1976 May;57(5):637-49. PubMed PMID: 775511. Epub 1976/05/01. eng.

123. McLean AL, Talmor M, Harper A, Fahey TJ, 3rd, Gayle LB, Hoffman LA. Expression of cyclooxygenase-2 in the periprosthetic capsule surrounding a silicone shell implant in the rat. Annals of plastic surgery. 2002 Mar;48(3):292-7. PubMed PMID: 11862035. Epub 2002/02/28. eng.

124. Marques M, Brown SA, Cordeiro ND, Rodrigues-Pereira P, Cobrado ML, Morales-Helguera A, et al. Effects of fibrin, thrombin, and blood on breast capsule formation in a preclinical model. Aesthetic surgery journal. 2011 Mar;31(3):302-9. PubMed PMID: 21385741. Epub 2011/03/10. eng.

125. Marques M, Brown SA, Rodrigues-Pereira P, Natalia M, Cordeiro DS, Morales-Helguera A, et al. Animal model of implant capsular contracture: effects of chitosan. Aesthetic surgery journal. 2011 Jul;31(5):540-50. PubMed PMID: 21719867. Epub 2011/07/02. eng.

126. Marques M, Brown SA, Cordeiro ND, Rodrigues-Pereira P, Cobrado ML, Morales-Helguera A, et al. Effects of coagulase-negative staphylococci and fibrin on breast capsule formation in a rabbit model. Aesthetic surgery journal. 2011 May;31(4):420-8. PubMed PMID: 21551433. Epub 2011/05/10. eng.

127. Bergmann PA, Tamouridis G, Lohmeyer JA, Mauss KL, Becker B, Knobloch J, et al. The effect of a bacterial contamination on the formation of capsular contracture with polyurethane breast implants in comparison with textured silicone implants: an animal study. Journal of plastic, reconstructive & aesthetic surgery : JPRAS. 2014 Oct;67(10):1364-70. PubMed PMID: 24953446. Epub 2014/06/24. eng.
128. Tamboto H, Vickery K, Deva AK. Subclinical (biofilm) infection causes capsular contracture in a porcine model following augmentation mammoplasty. Plastic and reconstructive surgery. 2010 Sep;126(3):835-42. PubMed PMID: 20811216. Epub 2010/09/03. eng.

129. Jacombs A, Tahir S, Hu H, Deva AK, Almatroudi A, Wessels WLF, et al. In Vitro and In Vivo Investigation of the Influence of Implant Surface on the Formation of Bacterial Biofilm in Mammary Implants. Plastic and reconstructive surgery. 2014;133(4):471e-80e. PubMed PMID: 00006534-201404000-00009.

130. Jacombs A, Allan J, Hu H, Valente PM, Wessels WL, Deva AK, et al. Prevention of biofilm-induced capsular contracture with antibiotic-impregnated mesh in a porcine model. Aesthetic surgery journal. 2012 Sep;32(7):886-91. PubMed PMID: 22942116. Epub 2012/09/04. eng.

131. Mendes PR, Bins-Ely J, Lima EA, Vasconcellos ZA, d'Acampora AJ, Neves RD. Histological study on acute inflammatory reaction to polyurethane-coated silicone implants in rats. Acta cirurgica brasileira. 2008 Jan-Feb;23(1):93-101. PubMed PMID: 18278399. Epub 2008/02/19. eng.

132. Arad E, Navon-Venezia S, Gur E, Kuzmenko B, Glick R, Frenkiel-Krispin D, et al. Novel rat model of methicillin-resistant Staphylococcus aureus-infected silicone breast implants: a study of biofilm pathogenesis. Plastic and reconstructive surgery. 2013 Feb;131(2):205-14. PubMed PMID: 23076419. Epub 2012/10/19. eng.

133. Cappellano G, Ploner C, Lobenwein S, Sopper S, Hoertnagl P, Mayerl C, et al. Immunophenotypic characterization of human T cells after in vitro exposure to different silicone breast implant surfaces. PloS one. 2018;13(2):e0192108.

134. Lechner MG, Megiel C, Church CH, Angell TE, Russell SM, Sevell RB, et al. Survival signals and targets for therapy in breast implant-associated ALK-anaplastic large cell lymphoma. Clinical cancer research : an official journal of the American Association for Cancer Research. 2012 Sep 01;18(17):4549-59. PubMed PMID: 22791880. Epub 2012/07/14. eng.

135. Kadin ME, Morgan J, Xu H, Epstein AL, Sieber D, Hubbard BA, et al. IL-13 is produced by tumor cells in breast implant-associated anaplastic large cell lymphoma: implications for pathogenesis. Human pathology. 2018 Aug;78:54-62. PubMed PMID: 29689246. Epub 2018/04/25. eng.

136. Prantl L, Poppl N, Horvat N, Heine N, Eisenmann-Klein M. Serologic and histologic findings in patients with capsular contracture after breast augmentation with smooth silicone gel implants: is serum hyaluronan a potential predictor? Aesthetic plastic surgery. 2005 Nov-Dec;29(6):510-8. PubMed PMID: 16328636. Epub 2005/12/06. eng.

137. Hwang K, Sim HB, Huan F, Kim DJ. Myofibroblasts and capsular tissue tension in breast capsular contracture. Aesthetic plastic surgery. 2010 Dec;34(6):716-21. PubMed PMID: 20512331. Epub 2010/06/01. eng.

138. Lesesne CB. Textured surface silicone breast implants: histology in the human. Aesthetic plastic surgery. 1997 Mar-Apr;21(2):93-6. PubMed PMID: 9143423. Epub 1997/03/01. eng.

139. Thomsen JL, Christensen L, Nielsen M, Brandt B, Breiting VB, Felby S, et al. Histologic changes and silicone concentrations in human breast tissue surrounding silicone breast prostheses. Plastic and reconstructive surgery. 1990 Jan;85(1):38-41. PubMed PMID: 2293734. Epub 1990/01/01. eng.

140. Copeland M, Choi M, Bleiweiss IJ. Silicone breakdown and capsular synovial metaplasia in textured-wall saline breast prostheses. Plastic and reconstructive surgery. 1994 Oct;94(5):628-33; discussion 34-6. PubMed PMID: 7938285. Epub 1994/10/01. eng.

141. Yeoh G, Russell P, Jenkins E. Spectrum of histological changes reactive to prosthetic breast implants: a clinopathological study of 84 patients. Pathology. 1996 Aug;28(3):232-5. PubMed PMID: 8912351. Epub 1996/08/01. eng.

142. Peters W, Smith D, Fornasier V, Lugowski S, Ibanez D. An outcome analysis of 100 women after explantation of silicone gel breast implants. Annals of plastic surgery. 1997 Jul;39(1):9-19. PubMed PMID: 9229086. Epub 1997/07/01. eng.

143. Gayou RM. A histological comparison of contracted and non-contracted capsules around silicone breast implants. Plastic and reconstructive surgery. 1979 May;63(5):700-7. PubMed PMID: 571127. Epub 1979/05/01. eng.
144. Siggelkow W, Faridi A, Spiritus K, Klinge U, Rath W, Klosterhalfen B. Histological analysis of silicone breast implant capsules and correlation with capsular contracture. Biomaterials. 2003 Mar;24(6):1101-9. PubMed PMID: 12504533. Epub 2002/12/31. eng.

145. Wyatt LE, Sinow JD, Wollman JS, Sami DA, Miller TA. The influence of time on human breast capsule histology: smooth and textured silicone-surfaced implants. Plastic and reconstructive surgery. 1998 Nov;102(6):1922-31. PubMed PMID: 9810987. Epub 1998/11/12. eng.

146. Carpaneda CA. Inflammatory reaction and capsular contracture around smooth silicone implants. Aesthetic plastic surgery. 1997 Mar-Apr;21(2):110-4. PubMed PMID: 9143426. Epub 1997/03/01. eng.

147. Wolfram D, Rainer C, Niederegger H, Piza H, Wick G. Cellular and molecular composition of fibrous capsules formed around silicone breast implants with special focus on local immune reactions. Journal of autoimmunity. 2004 Aug;23(1):81-91. PubMed PMID: 15236756. Epub 2004/07/09. eng.

148. Meza Britez ME, Caballero Llano C, Chaux A. Periprosthetic breast capsules and immunophenotypes of inflammatory cells. European journal of plastic surgery. 2012 Sep;35(9):647-51. PubMed PMID: 22904602. Pubmed Central PMCID: PMC3419835. Epub 2012/08/21. eng.

149. Kuhn A, Singh S, Smith PD, Ko F, Falcone R, Lyle WG, et al. Periprosthetic breast capsules contain the fibrogenic cytokines TGF-beta1 and TGF-beta2, suggesting possible new treatment approaches. Annals of plastic surgery. 2000 Apr;44(4):387-91. PubMed PMID: 10783094. Epub 2000/04/27. eng.

150. Rudolph R, Abraham J, Vecchione T, Guber S, Woodward M. Myofibroblasts and free silicon around breast implants. Plastic and reconstructive surgery. 1978 Aug;62(2):185-96. PubMed PMID: 678332. Epub 1978/08/01. eng.

151. Centeno JA, Mullick FG, Panos RG, Miller FW, Valenzuela-Espinoza A. Laser-Raman microprobe identification of inclusions in capsules associated with silicone gel breast implants. Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc. 1999 Jul;12(7):714-21. PubMed PMID: 10430276. Epub 1999/08/03. eng.

152. del Rosario AD, Bui HX, Petrocine S, Sheehan C, Pastore J, Singh J, et al. True synovial metaplasia of breast implant capsules: a light and electron microscopic study. Ultrastructural pathology. 1995 Mar-Apr;19(2):83-93. PubMed PMID: 7792953. Epub 1995/03/01. eng.

153. Legrand AP, Marinov G, Pavlov S, Guidoin MF, Famery R, Bresson B, et al. Degenerative mineralization in the fibrous capsule of silicone breast implants. Journal of materials science Materials in medicine. 2005 May;16(5):477-85. PubMed PMID: 15875259. Epub 2005/05/06. eng.

154. Amoresano A, De Stefano L, Rea I, Pane F, Birolo L, Schonauer F. Chemical and Structural Characterization of Several Mid-Term Explanted Breast Prostheses. Materials. 2016;9(8):678. PubMed PMID: doi:10.3390/ma9080678.

155. Giot JP, Paek LS, Nizard N, El-Diwany M, Gaboury LA, Nelea M, et al. The double capsules in macro-textured breast implants. Biomaterials. 2015 Oct;67:65-72. PubMed PMID: 26210173. Epub 2015/07/27. eng.

156. Virden CP, Dobke MK, Stein P, Parsons CL, Frank DH. Subclinical infection of the silicone breast implant surface as a possible cause of capsular contracture. Aesthetic plastic surgery. 1992 Spring;16(2):173-9. PubMed PMID: 1570781. Epub 1992/01/01. eng.

157. Dobke MK, Svahn JK, Vastine VL, Landon BN, Stein PC, Parsons CL. Characterization of microbial presence at the surface of silicone mammary implants. Annals of plastic surgery. 1995 Jun;34(6):563-9; discussion 70-1. PubMed PMID: 7661531. Epub 1995/06/01. eng.

158. Rieger UM, Mesina J, Kalbermatten DF, Haug M, Frey HP, Pico R, et al. Bacterial biofilms and capsular contracture in patients with breast implants. The British journal of surgery. 2013 May;100(6):768-74. PubMed PMID: 23468161. Epub 2013/03/08. eng.

159. Pajkos A, Deva AK, Vickery K, Cope C, Chang L, Cossart YE. Detection of subclinical infection in significant breast implant capsules. Plastic and reconstructive surgery. 2003 Apr 15;111(5):1605-11. PubMed PMID: 12655204. Epub 2003/03/26. eng.

160. Del Pozo JL, Tran NV, Petty PM, Johnson CH, Walsh MF, Bite U, et al. Pilot study of association of bacteria on breast implants with capsular contracture. Journal of clinical
microbiology. 2009 May;47(5):1333-7. PubMed PMID: 19261794. PubMed Central PMCID: PMC2681843. Epub 2009/03/06. eng.

161. Schreml S, Heine N, Eisenmann-Klein M, Prantl L. Bacterial colonization is of major relevance for high-grade capsular contracture after augmentation mammaplasty. Annals of plastic surgery. 2007 Aug;59(2):126-30. PubMed PMID: 17667403. Epub 2007/08/02. eng.

162. Poppler L, Cohen J, Dolen UC, Schriefer AE, Tenenbaum MM, Deeken C, et al. Histologic, Molecular, and Clinical Evaluation of Explanted Breast Prostheses, Capsules, and Acellular Dermal Matrices for Bacteria. Aesthetic surgery journal. 2015 Aug;35(6):653-68. PubMed PMID: 26229126. PubMed Central PMCID: PMC4649701. Epub 2015/08/01. eng.

163. Wolfram D, Rabensteiner E, Grundtman C, Bock G, Mayerl C, Parson W, et al. T regulatory cells and TH17 cells in peri-silicone implant capsular fibrosis. Plastic and reconstructive surgery. 2012 Feb;129(2):327e-37e. PubMed PMID: 22286447. Epub 2012/01/31. eng.

164. Hanson SE, Hassid VJ, Branch-Brooks C, Liu J, Kadin ME, Miranda R, et al. Validation of a CD30 Enzyme-Linked Immunosorbent Assay for the Rapid Detection of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthetic surgery journal. 2019 Feb 21. PubMed PMID: 30789639. Epub 2019/02/23. eng.

165. Kyle DJ, Harvey AG, Shih B, Tan KT, Chaudhry IH, Bayat A. Identification of molecular phenotypic descriptors of breast capsular contracture formation using informatics analysis of the whole genome transcriptome. Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society. 2013 Sep-Oct;21(5):762-9. PubMed PMID: 23941504. Epub 2013/08/15. eng.

166. Ulrich D, Ulrich F, Pallua N, Eisenmann-Klein M. Effect of Tissue Inhibitors of Metalloproteinases and Matrix Metalloproteinases on Capsular Formation Around Smooth and Textured Silicone Gel Implants. Aesthetic plastic surgery. 2009;33(4):555-62.

167. Baker JL, Jr., Chandler ML, LeVier RR. Occurrence and activity of myofibroblasts in human capsular tissue surrounding mammary implants. Plastic and reconstructive surgery. 1981 Dec;68(6):905-12. PubMed PMID: 7301985. Epub 1981/12/01. eng.

168. Ben Amar M, Wu M, Trejo M, Atlan M. Morpho-elasticity of inflammatory fibrosis: the case of capsular contracture. Journal of the Royal Society, Interface. 2015 Oct 06;12(111):20150343. PubMed PMID: 26446558. PubMed Central PMCID: PMC4614484. Epub 2015/10/09. eng.

169. Bodin F, Jung C, Dieval F, Chakfe N, Wisniewski S, Bruant Rodier C, et al. Aging of retrieved gel breast implants: a comparison between two product generations. Journal of the mechanical behavior of biomedical materials. 2015 Jun;46:11-22. PubMed PMID: 25746931. Epub 2015/03/10. eng.

170. Tortolano L, Yen-Nicolaý S, Rogliano P-F, Alkhashnam H, Honart J-F, Manerlax K, et al. Permeability of expander breast implants: in vitro and in vivo analyses. Journal of the mechanical behavior of biomedical materials.

171. Ramiao NG, Martins PS, Barroso ML, Santos DC, Fernandes AA. In vitro degradation of polydimethylsiloxanes in breast implant applications. Journal of applied biomaterials & functional materials. 2017 Nov 10;15(4):e369-e75. PubMed PMID: 28574093. Epub 2017/06/03. eng.

172. Tafti AP, Kirkpatrick AB, Alavi Z, Owen HA, Yu Z. Recent advances in 3D SEM surface reconstruction. Micron. 2015;78:54-66.

173. Podsiadlo P, Stachowiak G. Characterization of surface topography of wear particles by SEM stereoscopy. Wear. 1997;206(1-2):39-52.

174. Bariani P, De Chiffre L, Hansen HN, Horsewell A. Investigation on the traceability of three dimensional scanning electron microscope measurements based on the stereo-pair technique. Precision engineering. 2005;29(2):219-28.

175. Krishna AV, Flys O, Reddy VV, Rosén BG. Surface topography characterization using 3D stereoscopic reconstruction of SEM images. Surface Topography: Metrology and Properties. 2018 2018/05/16;6(2):024006.

176. Piazzesi G. Photogrammetry with the scanning electron microscope. Journal of Physics E: Scientific Instruments. 1973;6(4):392.
177. Kricheldorff J, Fallenberg EM, Solbach C, Gerber-Schafer C, Rancso C, Fritschen UV. Breast Implant-Associated Lymphoma. Deutsches Arzteblatt international. 2018 Sep 21;115(38):628-35. PubMed PMID: 30373708. Pubmed Central PMCID: PMC6218708. Epub 2018/10/31. eng.

178. Johnson L, O'Donoghue JM, McLean N, Turton P, Khan AA, Turner SD, et al. Breast implant associated anaplastic large cell lymphoma: The UK experience. Recommendations on its management and implications for informed consent. European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2017 May 18. PubMed PMID: 28596034. Epub 2017/06/10. eng.

179. Webb LH, Aime VL, Do A, Mossman K, Mahabir RC. Textured Breast Implants: A Closer Look at the Surface Debris Under the Microscope. Plastic Surgery. 2017;25(3):179-83.

180. Gefen A, Dilmoney B. Mechanics of the normal woman's breast. Technology and health care : official journal of the European Society for Engineering and Medicine. 2007;15(4):259-71. PubMed PMID: 17673835. Epub 2007/08/04. eng.

181. Garabédian C, Bigerelle M, Najjar D, Migaud H. Wear pattern on a retrieved Total Knee Replacement: The “fourth body abrasion”. Biotribology. 2017 2017/09/01;/11(Supplement C):29-43.

182. Najjar D, Bigerelle M, Migaud H, lost A. About the relevance of roughness parameters used for characterizing worn femoral heads. Tribology international. 2006;39(12):1527-37.

183. Bigerelle M, Hagege B, El Mansori M. Mechanical modelling of micro-scale abrasion in superfinish belt grinding. Tribology International. 2008;41(11):992-1001.

184. El-Haddad R, Lafarge-Claoue B, Garabedian C, Staub S. A 10-Year Prospective Study of Implant-Based Breast Augmentation and Reconstruction. Eplasty. 2018;18.
## THESIS SUMMARY

The first breast implant surface pattern approved by the American Food and Drug Administration (FDA) is Biocell texture commercialized by the American company Allergan in 1987. Most breast implant manufacturers then adopted similar surface patterning process. A report from the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) estimated that 85% of implants sold in France between 2007 and 2016 were textured. In 2011, the FDA warned of a possible association between breast implants and a rare and specific form of lymphoma: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The number of cases of BIA-ALCL has exploded since 2014-2015, with an over-representation of the Biocell texture in the statistics, which justified the withdrawal of the French market of these prostheses by the ANSM in April 2019.

This thesis aims to evaluate the impact of breast implant surface topography on the clinical performance of the device.

Firstly, a comparative study carried out on 3 surface measurement techniques, as well as a statistical analysis based on the multi-scale decomposition of the topographies, allowed us to propose a metrologically-validated measurement methodology taking into account the surface morphology and the scale and to highlight the inconsistencies of the ISO standard related to breast implants (ISO 14607). Then, a classification and a morphologically-relevant designation of the textures were proposed and validated by an original protocol of genetic analysis on human tissues and by a discriminant analysis carried out on a large base of topographical parameters.

Similar topographical and statistical analyzes were also conducted on prostheses removed from the human body (or explant) in order to quantify the damage according to the type of texture and to the scale.

These studies will enable the GROUPE SEBBIN to design a new anatomically-shaped prosthesis, which will combine tissue anchoring and minimization of inflammation and damage processes.

Keywords: breast implant ; ALCL; texture ; surface measurement ; roughness ; surface nomenclature ; gene expression ; discriminant analysis ; in vivo damage

## RESUME DE THESE

La première structuration de surface d'implants mammaires approuvée par l'agence sanitaire américaine Food and Drug Administration (FDA) est la texturation Biocell de l'Américain Allergan en 1987. La plupart des fabricants d'implants mammaires ont ensuite adopté des procédés permettant d'obtenir des texturations similaires pour la plupart. Un rapport de l'Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) a estimé que 85% des implants vendus en France entre 2007 et 2016 étaient texturés. En 2011, la FDA alerte sur une possible association entre les implants mammaires et une forme rare et spécifique de lymphome : le Lymphome Anaplasique à Grandes Cellules Associés aux Implants Mammaires (LAGC-AIM). Le nombre de cas de LAGC-AIM a explosé depuis 2014-2015, avec une sur-représentation de la texture Biocell dans les statistiques justifiant le retrait du marché français de ces prothèses par l'ANSM en avril 2019.

Ces travaux de thèse ont pour but d'évaluer l'impact de la topographie de surface des implants mammaires sur les performances cliniques du dispositif.

Premièrement, une étude comparative menée sur 3 techniques de mesure de surface, ainsi qu'une analyse statistique basée sur la décomposition multi-échelle des topographies, nous ont permis de proposer une méthodologie de mesure métrologiquement correcte prenant en compte la morphologie de surface et l'échelle et de jeter la lumière sur les faiblesses de la norme ISO relative aux implants mammaires (ISO 14607).

Ensuite, une classification et une dénomination morphologiquement pertinente des texturations ont été proposées et validées par un protocole original d'analyse génétique sur tissus humains et par une analyse discriminante menée sur une large base de paramètres topographiques.

Des analyses topographique et statistique similaires ont été également conduites sur prothèses retirées du corps humain (ou explant), afin de quantifier l'endommagement en fonction du type de texturation et de l'échelle.

Ces études permettront au GROUPE SEBBIN de concevoir une nouvelle prothèse de forme anatomique, qui alliera à la fois accroche tissulaire et minimisation des processus d'inflammation et d'endommagement.

Mots clés : implant mammaire ; LAGC ; texturation ; mesure de surface ; rugosité ; nomenclature des surfaces ; analyse discriminante ; endommagement *in vivo*