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.
Analysis of clinical adverse events of breast implants in MAUDE database
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.
Silicone breast implantSaline breast implantBreast implant illnessMAUDE
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