Picha G J, Goldstein J A
Department of Surgery, MetroHealth Medical Center of Case Western Reserve University, Cleveland, Ohio.
Plast Reconstr Surg. 1991 Mar;87(3):490-500. doi: 10.1097/00006534-199103000-00017.
The implant-tissue response to the silicone gel mammary prosthesis requires a more thorough evaluation in light of recent concerns related to human connective-tissue diseases, contracture, infection, and neoplasia. The silicone prosthesis is not a homogeneous implant but is a milieu of various silicone chemistries. Silicone polymer precursors and prosthesis components (silicone shells, shells extracted of their low-molecular-weight components, silica-free silicone, silicone oil, fumed silica, and silicone extract) were implanted subcutaneously using a nonhemorrhagic technique into the backs of Lew/SsN rats (n = 90), two implants per rat, for periods of 7, 14, 28, 56, and 90 days for a total of 6 implants per material per time period. Histologic analysis was performed on specimens from the harvested soft tissue. The intensity of the cellular and capsular response was lowest for the silicone oil and increased as the material's molecular weight increased and material compliance decreased. Fumed silica elicited the most highly reactive cellular response. From this study it is apparent that the polymer's molecular weight influences its migration, encapsulation, and intensity of cellular response. Further, the silicone extract distillate elicited a highly intense cellular response with pronounced lymphocyte invasion. The human relevance of this work awaits further correlation with implant retrieval and in vivo performance.
鉴于近期人们对人类结缔组织疾病、挛缩、感染和肿瘤形成的关注，需要对硅胶乳房假体的植入物-组织反应进行更全面的评估。硅胶假体不是一种均质的植入物，而是多种硅胶化学物质的混合物。使用非出血技术将硅胶聚合物前体和假体组件（硅胶壳、去除低分子量成分的壳、无二氧化硅硅胶、硅油、气相二氧化硅和硅胶提取物）皮下植入Lew/SsN大鼠（n = 90）的背部，每只大鼠植入两个，分别植入7、14、28、56和90天，每个材料在每个时间段共植入6个。对采集的软组织标本进行组织学分析。硅油引起的细胞和包膜反应强度最低，随着材料分子量的增加和材料顺应性的降低而增加。气相二氧化硅引起的细胞反应活性最高。从这项研究中可以明显看出，聚合物的分子量会影响其迁移、包封和细胞反应强度。此外，硅胶提取物馏出物引起了强烈的细胞反应，并伴有明显的淋巴细胞浸润。这项工作与人类的相关性有待进一步与植入物取出和体内性能进行关联研究。
