正确面对FDA对经阴道植入网片手术治疗盆腔器官脱垂的公告  

Prudent cognition of FDA announcement on the transvaginal surgical mesh treatment for pelvic organ prolapse

作　　者：谢冰[1] 王建六[1] XIE Bing;WANG Jian-liu(Depart-ment of Gynecologic Oncology,Peking University People’s Hospital,Beijing Key Laboratory of Female Pelvic Floor Disorders,the Research Center of Fe-male Pelvic Floor Disease of Peking University,Bei-jing 100044,China)

机构地区：[1]北京大学人民医院妇产科,北京市女性盆底疾病研究重点实验室,北京大学女性盆底疾病研究中心,北京100044

出　　处：《中国实用妇科与产科杂志》2020年第10期917-920,共4页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：国家重点研发计划(2018YFC2002204);北京市科技计划项目(D151100001915003)。

摘　　要：自2008年起,美国食品药品监督管理局(FDA)颁布了一系列有关经阴道植入网片(transvaginal mesh,TVM)手术治疗盆腔器官脱垂(pelvic organ prolapse,POP)的警示与公告,至今十余年来,盆底重建手术的网片植入与自体组织修补引起了全球妇科泌尿领域学者与医生的广泛关注。基于现有的临床研究,美国、加拿大、英国、澳大利亚等国家先后发布了TVM的禁售令。以上一系列举措对我国妇科盆底重建领域有较大影响,应予以高度重视,要科学客观面对FDA对TVM手术治疗POP的公告。Since 2008,the U.S. Food and Drug Administration(FDA)had published a series of notifications and announcements concerning transvaginal surgical mesh for pelvic organ prolapse in the USA.Since more than ten ysears ago,the transvaginal placement of mesh and the native tissue repair have aroused widespread concern in the urogynecology domain all over the world.Based on the existing scientific literature and input from clinical trials,the authorities from the United States,Canada,the United Kingdom,Australia and a few of other countries have released the ban on the use of TVM.The above series of measures have a tremendous impact on the urogynecologic field in China,so it is necessary to pay attention to it,and to make a more prudent and objective response to the FDA announcement on the transvaginal surgical mesh treatment for pelvic organ prolapse.

关 键 词：经阴道植入网片 盆腔器官脱垂 修复手术 

分 类 号：R713.3[医药卫生—妇产科学]