Departments of Urology, Healthcare Policy and Research, and Obstetrics and Gynecology, Weill Cornell Medical College-New York Presbyterian, New York, New York; the Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom; and the Division of Urogynecology, the Warren Alpert Medical School of Brown University, and Women & Infants Hospital, Providence, Rhode Island.
Obstet Gynecol. 2020 Mar;135(3):591-598. doi: 10.1097/AOG.0000000000003689.
To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs.
We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis.
We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4-6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27-1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2-9.3%) in the mesh group and 6.3% (5.9-6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications.
Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.
评估网片植入物在盆腔器官脱垂（POP）修复中的长期安全性和再次干预结果。
我们对 2008 年至 2016 年期间在纽约州住院和门诊手术环境中接受 POP 修复的女性进行了基于人群的队列研究。根据患者和手术特征以及网片组和非网片组之间的医院量，使用多变量逻辑回归获得每个个体的倾向评分。使用生存时间分析评估长期安全性事件和再次干预。
我们确定了 54194 名接受 POP 修复的女性（12989 名使用网片，41205 名未使用网片）。平均年龄为 59.8（±13.1）岁，中位随访时间为 4.7 年（四分位间距，2.4-6.8 年）。在倾向评分匹配的 12284 对女性中，与未经阴道网片修复相比，POP 修复使用网片与更高的再次干预风险相关（风险比 1.40，95%置信区间 1.27-1.54，P<.001）。网片组 5 年内再次干预的估计风险为 8.8%（95%置信区间 8.2-9.3%），非网片组为 6.3%（5.9-6.8%）。在接受再次干预的患者中，18.5%接受网片治疗的患者因网片相关并发症而再次干预。
即使经阴道网片已从市场上撤出，但网片并发症的风险并未随着时间的推移而降低，这些女性需要密切随访。对 POP 修复中使用网片的持续监测对于确保已经植入的女性的安全性至关重要。
