Analysis of clinical adverse events of breast implants in MAUDE database
WANG Xiaoyu
CAO Fan
ZHAO Xinyu
Abstract: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.
Keywords:Silicone breast implantSaline breast implantBreast implant illnessMAUDE
Publication Date:2024-10-15
Online Publishing Date:2025-08-15(First online date of this platform, not the publication date of the document)
Pages:3( 620-622 )
