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Re: The perils of commercially driven surgical innovation

机译:回复:商业驱动的外科手术创新的危险

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This courageous article addresses the growing use of mesh kits for vaginal prolapse repairs. The authors describe the seven stages in the career of surgical innovation starting with an optimistic report of early data leading to popular adoption and vigorous promotion only to be followed by appropriate analysis and abandonment, because the early claims were unfounded [1], Examples of this course are exemplified by the disastrous career of the ProteGen sling (Boston Scientific, Natick, Massachusetts, USA) and, more recently, ObTape (Mentor, Santa Barbara, California, USA). "Mesh and trocar" kits for gynaecologic surgery are now in the ascendant phase of their life cycle, although there has been no adequately powered study to suggest any advantage over traditional prolapse repairs. The authors point to a disjunction between legal permission to market a product and the prudent and ethical use of those products in clinical practice. Some proposals are suggested that might help moderate the excesses and dangers of current practice.
机译:这篇勇敢的文章谈到了越来越多地使用网状套件进行阴道脱垂修复。作者描述了外科手术创新过程中的七个阶段,首先是对早期数据的乐观报告,这些报告导致了广泛采用和大力推广,但随后进行了适当的分析和放弃,因为早期的主张没有根据[1]。当然,ProteGen吊索(波士顿科学公司,纳蒂克,美国马萨诸塞州)以及最近的ObTape(曼托尔,圣塔芭芭拉,美国加利福尼亚)的灾难性职业就是一例。妇科手术的“网罩和套管针”套件现在正处于生命周期的上升阶段,尽管没有足够的动力研究表明与传统的脱垂修复相比有任何优势。作者指出,在销售产品的法律许可与临床实践中对这些产品的审慎和道德使用之间存在脱节。提出了一些建议,可能有助于减轻当前做法的过度和危险。

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