Abstract：
BACKGROUND: Understanding the impact of breast implants on the histological response in the surrounding fibrous capsule is important; however, consensus is lacking on how to analyze implant capsules histologically. We aimed to develop a standardized histological assessment tool to be used in research potentially improving diagnostic accuracy and treatment strategies for capsular contracture.
METHODS: Biopsies of breast implant capsules from 480 patients who had undergone breast augmentation or reconstruction were collected and stained with hematoxylin and eosin. Initially, biopsies from 100 patients were analyzed to select histological parameters demonstrating the highest relevance and reproducibility. Then, biopsies from the remaining 380 patients were used to determine intra- and interobserver agreements of two blinded observers and agreement with a pathologist. Finally, we tested the association between the parameters and capsular contracture.
RESULTS: The histological assessment tool included ten parameters assessing the inflammatory, fibrotic, and foreign-body reaction to breast implants, each graded on two-, three-, or four-point scales. Intra- and interobserver agreements were almost perfect (0.83 and 0.80), and agreement with the pathologist was substantial (0.67). Four parameters were significantly correlated with capsular contracture, namely chronic inflammation with lymphocyte infiltration (p < 0.01), thickness of the collagen layer (p < 0.0001), fiber organization (p < 0.01), and calcification (p < 0.001).
CONCLUSIONS: This is the first validated histological assessment tool for breast implant capsules. The validated tool not only advances our understanding of capsular contracture but also sets a new standard for histological evaluation in breast implant research and clinical diagnostics.
METHODS: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
METHODS: Biopsies of breast implant capsules from 480 patients who had undergone breast augmentation or reconstruction were collected and stained with hematoxylin and eosin. Initially, biopsies from 100 patients were analyzed to select histological parameters demonstrating the highest relevance and reproducibility. Then, biopsies from the remaining 380 patients were used to determine intra- and interobserver agreements of two blinded observers and agreement with a pathologist. Finally, we tested the association between the parameters and capsular contracture.
RESULTS: The histological assessment tool included ten parameters assessing the inflammatory, fibrotic, and foreign-body reaction to breast implants, each graded on two-, three-, or four-point scales. Intra- and interobserver agreements were almost perfect (0.83 and 0.80), and agreement with the pathologist was substantial (0.67). Four parameters were significantly correlated with capsular contracture, namely chronic inflammation with lymphocyte infiltration (p < 0.01), thickness of the collagen layer (p < 0.0001), fiber organization (p < 0.01), and calcification (p < 0.001).
CONCLUSIONS: This is the first validated histological assessment tool for breast implant capsules. The validated tool not only advances our understanding of capsular contracture but also sets a new standard for histological evaluation in breast implant research and clinical diagnostics.
METHODS: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
摘要：
背景：了解乳房植入物对周围纤维囊的组织学反应的影响很重要；但是，关于如何从组织学上分析植入胶囊缺乏共识。我们旨在开发一种标准化的组织学评估工具，用于可能改善包膜挛缩的诊断准确性和治疗策略的研究。
方法：收集480例进行了隆胸或隆胸手术的患者的隆胸胶囊活检并用苏木精和伊红染色。最初，我们对100例患者的活检进行了分析,以选择具有最高相关性和可重复性的组织学参数.然后，其余380例患者的活组织检查用于确定两名盲化观察者的观察者内和观察者间协议以及与病理学家的协议.最后,我们测试了参数与包膜挛缩之间的关联.
结果：组织学评估工具包括十个评估炎症的参数，纤维化,和异物对乳房植入物的反应，每个等级为两个-，三-，或四点量表。观察员内部和观察员之间的协议几乎是完美的（0.83和0.80），与病理学家的一致是实质性的(0.67)。四个参数与包膜挛缩显著相关，即淋巴细胞浸润的慢性炎症（p<0.01），胶原蛋白层的厚度（p<0.0001），纤维组织(p<0.01)，钙化（p<0.001）。
结论：这是第一个经过验证的乳房植入物囊的组织学评估工具。经过验证的工具不仅增进了我们对包膜挛缩的理解，而且为乳房植入物研究和临床诊断中的组织学评估树立了新的标准。
方法：本期刊要求作者为每个提交的证据分配一个级别，该级别的证据适用于循证医学排名。这不包括评论文章，书评,和有关基础科学的手稿，动物研究,尸体研究，和实验研究。对于这些循证医学评级的完整描述，请参阅目录或在线作者说明www。springer.com/00266.
方法：收集480例进行了隆胸或隆胸手术的患者的隆胸胶囊活检并用苏木精和伊红染色。最初，我们对100例患者的活检进行了分析,以选择具有最高相关性和可重复性的组织学参数.然后，其余380例患者的活组织检查用于确定两名盲化观察者的观察者内和观察者间协议以及与病理学家的协议.最后,我们测试了参数与包膜挛缩之间的关联.
结果：组织学评估工具包括十个评估炎症的参数，纤维化,和异物对乳房植入物的反应，每个等级为两个-，三-，或四点量表。观察员内部和观察员之间的协议几乎是完美的（0.83和0.80），与病理学家的一致是实质性的(0.67)。四个参数与包膜挛缩显著相关，即淋巴细胞浸润的慢性炎症（p<0.01），胶原蛋白层的厚度（p<0.0001），纤维组织(p<0.01)，钙化（p<0.001）。
结论：这是第一个经过验证的乳房植入物囊的组织学评估工具。经过验证的工具不仅增进了我们对包膜挛缩的理解，而且为乳房植入物研究和临床诊断中的组织学评估树立了新的标准。
方法：本期刊要求作者为每个提交的证据分配一个级别，该级别的证据适用于循证医学排名。这不包括评论文章，书评,和有关基础科学的手稿，动物研究,尸体研究，和实验研究。对于这些循证医学评级的完整描述，请参阅目录或在线作者说明www。springer.com/00266.
