向食品和药物管理局报告的并发症：泌尿妇科网片的横断面比较。
Complications Reported to the Food and Drug Administration: A Cross-sectional Comparison of Urogynecologic Meshes.
机构信息
From the Division of Urogynecology, University of Pittsburgh Medical Center, Pittsburgh, PA.
出版信息
Female Pelvic Med Reconstr Surg. 2022 Jul 1;28(7):452-460. doi: 10.1097/SPV.0000000000001193. Epub 2022 Apr 28.
IMPORTANCE
The U.S. Food and Drug Administration uses the Manufacturer and User Facility Device Experience database to evaluate the safety of urogynecologic meshes; however, reports on individual meshes have not been characterized.
OBJECTIVE
The aim of the study was to compare complications among available urogynecologic meshes reported to the Manufacturer and User Facility Device Experience database.
STUDY DESIGN
This study is a cross-sectional analysis of medical device reports (MDRs) of urogynecologic mesh from January 2004 to March 2019, using the Reed Tech Navigator (LexisNexis), which codes MDRs. The percentage of reports containing specific complaints (not an adverse event rate) were compared with χ 2 tests with Dunn-Sidak correction. Correlations with time on market, mesh weight, stiffness, and porosity were determined.
RESULTS
The 34,485 reports examined included 6 transvaginal meshes, 4 sacrocolpopexy meshes, and 10 midurethral slings. Most reported events were pain, erosion, and infection. For transvaginal prolapse, less than 10% of Uphold Lite (Boston Scientific) reports contained pain or erosion versus greater than 90% of Prolift/Prolift+M (Ethicon, P < 0.001). For sacrocolpopexy mesh, greater than 90% of Gynemesh (Ethicon; Prolift in vaginal form) reports included erosion and pain versus less than 60% for Artisyn (Ethicon), Restorelle (Colpoplast), and Upsylon (Boston Scientific, P < 0.0001). For slings, Gynecare TVT Obturator had the highest proportion of erosion and pain complaints. Heavier sling meshes had more reports. When Ascend (Caldera Medical), an outlier with only 5 reports, was excluded, transvaginal mesh stiffness correlated strongly with number of reports. For transvaginal meshes, number of reports correlated with time on market (ρ = 0.8, P = 0.04).
CONCLUSIONS
Individual meshes have different properties with different complication profiles, which should inform mesh development and use. Gynemesh MDRs included pain and erosion more frequently than others. Comprehensive registries are needed.
重要性
美国食品和药物管理局使用制造商和用户设施设备经验数据库来评估尿妇科网片的安全性;然而，尚未对个别网片的报告进行特征描述。
目的
本研究旨在比较制造商和用户设施设备经验数据库报告的现有尿妇科网片的并发症。
研究设计
这是一项对 2004 年 1 月至 2019 年 3 月期间使用 Reed Tech Navigator（LexisNexis）对尿妇科网片的医疗器械报告（MDR）进行的横断面分析，该工具对 MDR 进行编码。使用 χ 2 检验（带 Dunn-Sidak 校正）比较报告中特定投诉（非不良事件率）的百分比。还确定了与市场投放时间、网片重量、硬度和孔隙率的相关性。
结果
共检查了 34485 份报告，其中包括 6 份经阴道网片、4 份骶骨前阴道固定网片和 10 份中段尿道吊带。大多数报告的事件是疼痛、侵蚀和感染。对于经阴道脱垂，Uphold Lite（波士顿科学公司）报告中不到 10%的疼痛或侵蚀报告与 Prolift/Prolift+M（Ethicon，P < 0.001）的报告相比大于 90%。对于骶骨前阴道固定网片，Gynemesh（Ethicon；阴道形式的 Prolift）报告中超过 90%的报告包含侵蚀和疼痛，而 Artisyn（Ethicon）、Restorelle（Colpoplast）和 Upsylon（波士顿科学公司）的报告中不到 60%，P < 0.0001。对于吊带，Gynecare TVT 闭孔器的侵蚀和疼痛投诉比例最高。较重的网片有更多的报告。当 Ascend（Caldera Medical）这个仅有 5 份报告的异常值被排除在外时，经阴道网片硬度与报告数量之间存在很强的相关性。对于经阴道网片，报告数量与市场投放时间相关（ρ=0.8，P=0.04）。
结论
个别网片具有不同的特性，并发症情况也不同，这应能为网片的开发和使用提供信息。Gynemesh 的 MDR 报告更频繁地出现疼痛和侵蚀。需要全面的登记册。
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