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Influence of surface texturing on the biocompatibility of breast implants: upstream and clinical approaches

Abstract : 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 overrepresentation 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.
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Submitted on : Thursday, September 30, 2021 - 10:08:34 AM
Last modification on : Monday, February 7, 2022 - 3:27:43 PM


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  • HAL Id : tel-03359321, version 1


Charles Garabedian. Influence of surface texturing on the biocompatibility of breast implants: upstream and clinical approaches. Engineering Sciences [physics]. Université Polytechnique Hauts-de-France, 2019. English. ⟨NNT : 2019UPHF0007⟩. ⟨tel-03359321⟩



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