北京生物醫(yī)學(xué)工程

硅凝膠乳房植入體的老化研究進展

Research Progress of Silicone Gel Breast Implants Aging

作者：李莉王春仁

單位：中國藥品生物制品檢定所，醫(yī)療器械檢測中心（北京100050）

分類號：

出版年·卷·期（頁碼）：2010·29·2（210-214）

摘要：

硅凝膠乳房植入體作為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會各界廣泛的關(guān)注。近幾年圍繞硅凝膠乳房植入體的術(shù)后并發(fā)癥和健康問題等做了大量的研究。但因為老化引起的各種問題，如隨著植入時間的延長發(fā)生硅橡膠外殼破裂、硅凝膠滲漏、材料變性以及由此產(chǎn)生的對人體的影響等問題的研究尚不深入。本文在對硅凝膠乳房植入體老化穩(wěn)定性研究的現(xiàn)狀進行綜述的基礎(chǔ)上，對目前存在的問題和研究前景進行了探討。目前在硅凝膠乳房植入體老化穩(wěn)定性評價方面可用的臨床數(shù)據(jù)有限和缺乏設(shè)計較好的實驗，需要進一步研究以建立合適的評價方法。

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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