经阴道植入网片上市后安全性评价及监管措施分析  

Post-marketing safety reevaluation of transvaginal impalantation mesh and regulatory measures analysis

作　　者：赵一飞 赵燕 李栋 董放 Zhao Yifei;Zhao Yan;Li Dong;Dong Fang(Department of Medical Device Monitoring and Evaluation,Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,P.R.China)

机构地区：[1]国家药品监督管理局药品评价中心医疗器械监测和评价部,北京100076

出　　处：《中国计划生育和妇产科》2024年第11期43-48,共6页Chinese Journal of Family Planning & Gynecotokology

基　　金：国家重点研发计划(项目编号:2021YFC2701300,2021YFC2701302)。

摘　　要：目的 分析经阴道植入网片的安全性及各国监管机构采取的控制措施,探讨我国该领域后续应采取的措施。方法 以OTP为代码,检索FDA的制造商和用户设施设备经验(Manufacturer and User Facility Device Experience, MAUDE)数据库中2019年1月1日至2023年12月31日的数据,剔除其中的重复报告、文献报道以及登记注册研究的病例报告,对剩余的个例报告按照伤害表现和故障表现例次进行频率分布的统计分析,并检索Pubmed及中国知网、万方数据库,对经阴道网片植入风险和各国监管措施进行分析归纳。结果 共检索到1 359例经阴道植入网片产品的不良事件报告,最终纳入分析1 258例。前10位的手术并发症等不良事件为:疼痛,网片侵蚀,失禁,性交困难,便秘,损伤,白带异常,脱垂,泌尿道感染,精神、情绪或行为问题。前10位的质量及故障隐患为:迁移,耗材或组件的分离,材料侵蚀,缺陷耗材,耗材使用问题,患者耗材交互问题,放置位置问题,材料劈裂、切割或撕裂,材料突出或挤压,材料完整性问题。各国对此类产品采取了发布公共卫生通告、安全性通报,启动上市后监测、升类与撤市,甚至禁止销售等各种不同的监管措施。结论 使用经阴道植入网片存在网片暴露、网片侵蚀等额外风险,中国术者应在严格把握适应证、加强培训、及时随访的情况下谨慎使用,并同时开展注册登记研究,以收集中国人群使用经阴道植入网片产品的安全性数据,进一步评估该产品的安全性。Objective To analyze the safety of adverse events of transvaginal implantation mesh and the control measures taken by regulatory agencies in various countries,and to explore the follow-up measures to be taken in this field in China.Methods The data of the FDA's Manufacturer and User Facility Device Experience(MAUDE)from January 1,2019 to December 31,2023 were searched using OTP as the code,and the duplicate reports,literature reports and case reports of registered studies were excluded,and the frequency distribution of the remaining individual reports was analyzed according to the number of injury manifestations and failure manifestations.Pubmed,CNKI and Wanfang databases were searched to analyze and summarize the risks of transvaginal impalantation mesh implantation and the regulatory measures of various countries.Result A total of 1359 adverse event reports of transvaginal implantation mesh products were retrieved,and 1258 cases were included in the analysis.The top 10 adverse events such as surgical complications were:pain,mesh erosion,incontinence,dyspareunia,constipation,injury,abnormal vaginal discharge,prolapse,urinary tract infection,and mental,emotional,or behavioral problems.The top 10 quality and failure hazards were:migration,separation of consumables or components,material erosion,defective consumables,consumables use problems,patient consumables interaction problems,placement problems,material splitting,cutting or tearing,material protrusion or extrusion,and material integrity problems.Countries have adopted various regulatory measures for such products,such as issuing public health notices,safety notices,initiating post-market surveillance,upgrading and delisting,and even banning the sale of such products.Conclusion The use of transvaginal mesh has additional risks such as mesh exposure and mesh erosion,and Chinese surgeons should use it with caution under strict indications,strengthened training,and timely follow-up,and at the same time carry out registration studies to collect safety data on the

关 键 词：经阴道植入网片 盆腔器官脱垂 上市后评价 安全性 

分 类 号：R711.23[医药卫生—妇产科学]