Presentation and management of major complications of midurethral slings: Are complications under-reported?
Presentation and management of major complications of midurethral slings: Are complications under-reported?
复制标题
DOI：
10.1002/nau.20357
复制
发表时间：
2007-01-01
影响因子：
2
通讯作者：
Rodriguez, Larissa V.
中科院分区：
文献类型：
--
作者：
Deng, Donna Y.;Rutman, Matthew;Rodriguez, Larissa V.
目的：尿道中段悬吊术因其有效性和低并发症发生率而成为压力性尿失禁（SUI）治疗的主要方法。本研究的目的是报告这些微创治疗前的主要并发症的表现和治疗，并强调文献与美国食品药品监督管理局（FDA）器械失效数据库之间的主要并发症差异。方法：从2001年至2005年，我们回顾了所有的尿道中段吊带并发症，提出了我们的机构。对同一时间段内尿道中段吊带引起的所有并发症进行了文献综述，并对FDA制造商和用户机构器械经验（MAUDE）数据库中自我报告的并发症进行了查询。结果：共有26例因吊带放置后排尿功能障碍而转诊至UCLA的患者发现尿道或膀胱中有补片。治疗需要结合尿道松解术和补片取出、尿道重建术和膀胱切除术。与世界文献中报告的严重并发症<1%进行了比较。MAUDE数据库包含161例严重并发症，共报告了928例尿道下悬吊术并发症。MAUDE中报告的严重并发症明显多于已发表文献。结论：虽然罕见，但尿道中段悬吊术的主要并发症比文献中出现的更常见。涉及尿道和膀胱穿孔的破坏性并发症可表现为轻微的泌尿系统症状，因此可能诊断不足和报告不足。大多数情况下，这些病例需要进行额外的重建手术。
Aims: Midurethral slings have become the mainstay of stress urinary incontinence (SUI) treatment due to their efficacy and low complication rates. The purpose of this study was to report the presentation and treatment of major complications front these minimally invasive treatments presented to a tertiary referral practice and to highlight a discrepancy in major complications between literature and the food and drug administration (FDA) device failure database. Methods: From 2001 through 2005, we reviewed all cases of midurethral sling complications that presented to our institution. A literature review of all complications due to midurethral slings during the same time period was performed as was the FDA manufacturer and user facility device experience (MAUDE) database queried for self-reported complications. Results: A total of 26 patients referred to UCLA with voiding dysfunction after sling placement was found to have mesh in the urethra or bladder. Treatments required a combination of urethrolysis with mesh removal, urethral reconstruction with graft, and bladder excision. These were compared to major complications reported in the world literature of < 1%. The MAUDE database contained 161 major complications out of a total of 928 complications reported for suburethral slings. There was significantly more major complications reported in MAUDE than in published literature. Conclusions: Although rare, major complications of midurethral slings are more common than appear in literature. Devastating complications involving urethral and bladder perforations can present with mild urinary symptoms and thus are likely under-diagnosed and under-reported. Most of these cases need to be managed with additional reconstructive surgery.