取出乳房植入体的物理性能分析  

Physical Properties Analysis of Retrieved Mammary Implant

作　　者：谢胜芬 刘珍珍[1] 肖燕萍[1] XIE Sheng-fen;LIU Zhen-zhen;XIAO Yan-ping(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510080)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510080

出　　处：《中国医疗器械信息》2022年第11期27-29,共3页China Medical Device Information

摘　　要：乳房植入体作为植入性高风险医疗器械,直接关系到患者的身心健康和生活质量。这类产品属于长期植入器械,且涉及面广,其有效性和安全性一直受到社会的密切关注,产品植入人体后,乳房植入物会随着植入时间的延长,逐渐老化,各项力学性能指标会存在性能降低的现象,破裂发生率也将增大,加大了硅凝胶填充物从外壳渗出进入人体组织的风险。乳房植入物破裂、渗漏会给患者带来非常大的伤害。文章对医院取出的硅凝胶填充乳房植入体的物理性能进行测试,与现行标准进行对比,进行风险分析,并提出相关建议。As an implantable high-risk medical device,mammary implant is directly related to the physical and mental health and quality of life of patients.Such products are long-term implantable devices and involve a wide range of areas.Their effectiveness and safety have always been closely watched by the society.After the product is implanted into the human body,mammary implant will gradually become more mature with the extension of implantation time.The mechanical properties will decrease in Properties,and the probability of rupture will also increase,which will increase the risk of silicone gel infusing from the shell to human tissue.mammary implant rupture and leakage will cause great harm to patients,This paper tests the physical Properties of silicone gel Filled mammary implant retrieved by the hospital,Against current standards,analyzes the risk,and puts forward relevant suggestions.

关 键 词：取出的硅凝胶填充乳房植入体 测试 物理性能 风险 

分 类 号：TH789[机械工程—仪器科学与技术]