4.0 Article

The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics

期刊

出版社

LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/SPV.0000000000000433

关键词

transvaginal mesh; litigation; pelvic organ prolapse; stress urinary incontinence

向作者/读者索取更多资源

Objectives: Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims. This research analyzes the transvaginal mesh claims filed in the United States to identify key characteristics that may inform clinical decision-making. Methods: We evaluated a 1% random sample from the Bloomberg Law Database: 2000 to 2014 and associated legal documents. Outcomes and measures used included annual rate of claim, mesh type, time interval between surgery and claim, defendants, and surgeon training. Results: The search returned 76,865 results, and 2979 were excluded, leaving 73,915 claims. Of 739 claims (1%), 63.3% involved slings for SUI, 13.3% mesh for POP, and 165 (23.2%) involved both. The mesh named most often in claims was retropubic slings at 30.3% and transobturator slings at 27.1%. The number of cases filed increased significantly from 730 in 2011 to 11,798 in 2012, which then almost tripled in 2013 to 34,017. The interval from surgery to claim filing ranged from 4.8 to 5.3 years. Only 12% of implanting surgeons were or became board certified in Female Pelvic Medicine and Reconstructive Surgery. Only 4 cases named providers as codefendants. Conclusions: Most legal claims involved slings for SUI and began after the 2011 Food and Drug Administration communication about mesh for POP. The rise in lawsuits does not reflect the acceptably low complication rates for slings for SUI reported in the literature.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.0
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

暂无数据
暂无数据