Department of Urology, Weill Cornell Medical College, New York-Presbyterian Hospital, New York.
Obstetrics, Gynecology, and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.
JAMA Surg. 2017 Mar 1;152(3):257-263. doi: 10.1001/jamasurg.2016.4200.
Mesh, a synthetic graft, has been used in pelvic organ prolapse (POP) repair and stress urinary incontinence (SUI) to augment and strengthen weakened tissue. Polypropylene mesh has come under scrutiny by the US Food and Drug Administration.
To examine the rates of mesh complications and invasive reintervention after the placement of vaginal mesh for POP repair or SUI surgery.
DESIGN, SETTING, AND PARTICIPANTS: This investigation was an observational cohort study at inpatient and ambulatory surgery settings in New York State. Participants were women who underwent transvaginal repair for POP or SUI with mesh between January 1, 2008, and December 31, 2012, and were followed up through December 31, 2013. They were divided into the following 4 groups based on the amount of mesh exposure: transvaginal POP repair surgery with mesh and concurrent sling use (vaginal mesh plus sling group), transvaginal POP repair with mesh and no concurrent sling use (vaginal mesh group), transvaginal POP repair without mesh but concurrent sling use for SUI (POP sling group), and sling for SUI alone (SUI sling group).
The primary outcome was the occurrence of mesh complications and repeated invasive intervention within 1 year after the initial mesh implantation. A time-to-event analysis was performed to examine the occurrence of mesh erosions and subsequent reintervention. Secondary analyses of an age association (<65 vs ≥65 years) were conducted.
The study identified 41 604 women who underwent 1 of the 4 procedures. The mean (SD) age of women at their initial mesh implantation was 56.2 (13.0) years. The highest risk of erosions was found in the vaginal mesh plus sling group (2.72%; 95% CI, 2.31%-3.21%) and the lowest in the SUI sling group (1.57%; 95% CI, 1.41%-1.74%). The risk of repeated surgery with concomitant erosion diagnosis was also the highest in the vaginal mesh plus sling group (2.13%; 95% CI, 1.76%-2.56%) and the lowest in the SUI sling group (1.16%; 95% CI, 1.03%-1.31%).
The combined use of POP mesh and SUI mesh sling was associated with the highest erosion and repeated intervention risk, while mesh sling alone had the lowest erosion and repeated intervention risk. There is evidence for a dose-response relationship between the amount of mesh used and subsequent mesh erosions, complications, and invasive repeated intervention.
网片是一种合成移植物，已被用于治疗盆腔器官脱垂（POP）和压力性尿失禁（SUI），以增强和加强薄弱组织。聚丙烯网片受到美国食品和药物管理局的审查。
检查阴道网片修复 POP 或 SUI 手术后网片并发症和侵入性再干预的发生率。
设计、设置和参与者：这是一项在纽约州住院和门诊手术环境中进行的观察性队列研究。参与者为 2008 年 1 月 1 日至 2012 年 12 月 31 日期间接受经阴道修复术治疗 POP 或 SUI 并接受随访至 2013 年 12 月 31 日的女性。根据网片暴露量，她们被分为以下 4 组：经阴道 POP 修复术伴网片和同期吊带使用（阴道网片加吊带组）、经阴道 POP 修复术伴网片但不伴同期吊带使用（阴道网片组）、经阴道 POP 修复术无网片但同期吊带用于 SUI（POP 吊带组）和吊带单独用于 SUI（SUI 吊带组）。
主要结局是初次网片植入后 1 年内发生网片并发症和重复侵入性干预。进行了时间事件分析以检查网片侵蚀和随后的再干预的发生情况。还进行了年龄相关性的二次分析（<65 岁与≥65 岁）。
研究确定了 41604 名接受了 4 种手术之一的女性。女性初次网片植入时的平均（SD）年龄为 56.2（13.0）岁。网片加吊带组发生侵蚀的风险最高（2.72%；95%CI，2.31%-3.21%），SUI 吊带组发生侵蚀的风险最低（1.57%；95%CI，1.41%-1.74%）。网片加吊带组同时伴有侵蚀诊断的再次手术风险也最高（2.13%；95%CI，1.76%-2.56%），SUI 吊带组的风险最低（1.16%；95%CI，1.03%-1.31%）。
POP 网片和 SUI 网片吊带联合使用与最高的侵蚀和重复干预风险相关，而单独使用网片吊带与最低的侵蚀和重复干预风险相关。有证据表明，使用的网片数量与随后的网片侵蚀、并发症和侵入性重复干预之间存在剂量反应关系。
