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美国食品与药品监督管理局(FDA)于2014年4月11日发布了电动组织分碎器在子宫肌瘤微创手术中应用的声明[1],随之美国强生公司宣布其公司产品组织分碎器退市。关于妇科腹腔镜手术中使用组织分碎器问题,引起了国内妇产科学界的广泛关注,造成了一定混乱。如何科学解读美国FDA的声明,以及合理使用组织分碎器,防范相关并发症发生值得关注。一、科学理解美国FDA声明美国FDA发表组织分碎器的声明是基于在使用过程中,误将恶性肿瘤组织在盆腹腔内分碎,造成医源性肿瘤播散和转移,引起严重的后果。而美国强生公司的产品退市行为是公司商业运营决定,
On April 11, 2014, the U.S. Food and Drug Administration (FDA) issued a statement on the application of electric tissue shredder in minimally invasive surgery of uterine fibroids [1], followed by the announcement by Johnson & Johnson that the company’s product organization Disassemble delisting. About the use of tissue disintegrator in gynecological laparoscopic surgery has aroused widespread concern in the domestic obstetrics and gynecology, resulting in some confusion. How to interpret the statement of the U.S. FDA in a scientific way and how to properly use the tissue disassembler to prevent the occurrence of related complications are of concern. First, the scientific understanding of the United States FDA statement FDA issued a statement on the organization broken machine is based on the use of the process, mistakenly broken the pelvic cavity of malignant tissue, resulting in iatrogenic tumor dissemination and transfer, causing serious consequences. Johnson & Johnson’s product delisting is the decision of the company’s commercial operation,