MAUDE数据库中乳房置入假体的临床不良事件分析  

Analysis of clinical adverse events of breast implants in MAUDE database

作　　者：王晓禹 曹帆 赵新宇 WANG Xiaoyu;CAO Fan;ZHAO Xinyu(Deparememt of Mediacl Engineering,Suzhou Municipal Hospital,Suzhou 215008,China)

机构地区：[1]苏州市立医院医学工程处,江苏苏州215008 [2]苏州市药品不良反应监测中心,江苏苏州215008

出　　处：《中国美容整形外科杂志》2024年第10期620-622,共3页Chinese Journal of Aesthetic and Plastic Surgery

摘　　要：制造商和用户设备体验数据库(manufacturer and user facility device experience database,MAUDE)是美国FDA管理医疗器械不良事件的国家数据库,乳房假体作为医用器械材料在MAUDE数据库中存在大量不良事件的报道,检索并下载自2020年11月1日至2023年10月31日所有不良事件,其中主要包括临床常见的局部并发症和非特异性的乳房置入疾病(breast implant illness,BII)。目前在学术界对BII的发生与乳房假体之间的因果关系尚无定论,而对BII的更好理解可能会让患者进一步思考乳房置入的益处是否大于风险。笔者现就乳房假体置入的风险和不良反应作一综述。The manufacturer and user facility device experience database(MAUDE)is a national database of adverse events of medical devices managed by the FDA.As a medical device material,breast implants have a large number of adverse events reported in the MAUDE database.Retrieve and download all adverse events from November 1,2020 to October 31,2023,It mainly includes common local complications and non-specific breast implant illness(BII).At present,the causal relationship between the occurrence of BII and breast prosthesis is inconclusive in academia,and a better understanding of BII may allow beauty seekers to further consider whether the benefits of breast implantation outweigh the risks.Here is to make a review of the the risks and adverse reactions of breast prosthesis implantation.

关 键 词：硅胶乳房假体 生理盐水乳房假体 乳房置入疾病 MAUDE 

分 类 号：R655.8[医药卫生—外科学]