经阴道网十年

C. Maher, N. Haya
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引用次数: 3

摘要

在经阴道补片时代,一些妇女在插入经阴道补片进行盆腔器官脱垂的手术治疗后出现了意想不到的不良结果。为了最大限度地减少这些事件重复的风险,我们支持改变新器械的批准流程,包括上市前的安全性和有效性论证。临床医生应该在新技术的引入阶段表现出更大的警惕,包括对没有充分安全性和有效性数据的程序征求伦理委员会的批准。临床医生和行业之间“一臂之长”关系的正规化将有助于最大限度地减少可能不恰当地影响新技术引入的利益冲突,并提高透明度和信心。大学和教育协会的选举代表与行业没有任何关系,这可以促进临床医生与行业之间的“一臂距离”关系,这是我们社区所要求的。这些变化是为了规范……
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The transvaginal mesh decade
During the transvaginal mesh era some women have suffered unexpectedly poor outcomes following the insertion of transvaginal mesh for the surgical management of pelvic organ prolapse. To minimize the risk of these events repeating, we support changes to approval process of new devices including premarket demonstration of safety and efficacy. Clinicians should demonstrate greater vigilance in the introductory phase of new technologies including incorporating ethics committee approval for procedures without adequate safety and efficacy data. Formalization of an ‘arm’s length’ relationship between clinicians and industry would help minimize conflicts of interest which may unduly bias the introduction of new technologies and create improved transparency and confidence. Colleges and educational societies where the elected representatives are free of any relationship with industry could facilitate the ‘arm’s length’ relationship between clinician and industry that our community demands. These changes to regulat...
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