北京生物医学工程

硅凝胶乳房植入体的老化研究进展

Research Progress of Silicone Gel Breast Implants Aging

作者：李莉王春仁

单位：中国药品生物制品检定所，医疗器械检测中心（北京100050）

分类号：

出版年·卷·期（页码）：2010·29·2（210-214）

摘要：

硅凝胶乳房植入体作为乳房重建和整形常用的植入材料，其生物安全性一直受到社会各界广泛的关注。近几年围绕硅凝胶乳房植入体的术后并发症和健康问题等做了大量的研究。但因为老化引起的各种问题，如随着植入时间的延长发生硅橡胶外壳破裂、硅凝胶渗漏、材料变性以及由此产生的对人体的影响等问题的研究尚不深入。本文在对硅凝胶乳房植入体老化稳定性研究的现状进行综述的基础上，对目前存在的问题和研究前景进行了探讨。目前在硅凝胶乳房植入体老化稳定性评价方面可用的临床数据有限和缺乏设计较好的实验，需要进一步研究以建立合适的评价方法。

Silicone gel breast implants (SGBI) have been used for breast augmentation and reconstructive surgery, and their biosafety has been subject to public concern In recent years, many studies on the postoperative complication and health problems associated with SGBI implantation were performed However various problems caused by the aging such as the shell rupture,gel bleeding,material degeneration and the resulting impact to patient after implantation has not been studied systemicallyThis paper summarizes the research status quo of the aging stabilitly of silicone gel breast implants,and discusses the current problems and prospects, The systemic evaluation on the stability of SGBI with in vitro tests and animal experiments are still needed since the limited availability of documented clinical data, and welldesigned clinical studies.

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