Renaissance School of Medicine at Stony Brook University, Stony Brook, NY.
Department of Urology, Stony Brook University Medical Center, Stony Brook, NY.
Urology. 2021 Apr;150:151-157. doi: 10.1016/j.urology.2020.06.053. Epub 2020 Jul 11.
To investigate the utilization of mesh slings for stress urinary incontinence (SUI) across time - before and after the 2011 US Food and Drug Administration (FDA) public health notification regarding an increase in adverse events related to transvaginal mesh (TVM) for pelvic organ prolapse (POP) repair - and among FPMRS-certified urologists and gynecologists and non-FPMRS counterparts using a statewide database.
The New York Statewide Planning and Research Cooperative System all-payer database was utilized to extract outpatient Current Procedural Terminology procedure codes for SUI mesh sling utilization and revision or removal performed between 2007 and 2015.
After the 2011 FDA warning on POP with TVM, sling placement decreased by 43% from 5214 cases in 2011 to 2958 in 2015. However, over the study period, the rate of sling revision remained stable relative to total sling placement. The rise and fall in mesh sling usage for SUI was primarily driven by non-FPMRS providers. FPMRS providers performed a higher proportion of sling procedures. The number of FPMRS physicians also increased from 2011 to 2015, and each individual physician had a higher median case volume for sling placements and revisions.
In New York state, utilization of mesh slings for SUI has significantly decreased since the 2011 FDA public health notification, without any specific warning for the utilization of mesh in this setting. This trend was mainly driven by a decrease in mesh usage among non-FPMRS physicians, although the specific causality is likely complex.
调查 2011 年美国食品和药物管理局(FDA)发布公共卫生通知后,即有关阴道网片(TVM)治疗盆腔器官脱垂(POP)修复的不良事件增加后,以及在 FPMRS 认证的泌尿科医生和妇科医生与非 FPMRS 同行之间,随时间推移(在此之前和之后),用于治疗压力性尿失禁(SUI)的网片吊带的利用情况,并使用全州数据库进行研究。
利用纽约州全州规划和研究合作系统的所有支付者数据库,提取 2007 年至 2015 年期间用于 SUI 网片吊带利用以及修复或移除的门诊 Current Procedural Terminology 程序代码。
在 2011 年 FDA 发布关于 TVM 治疗 POP 的警告后,吊带放置数量从 2011 年的 5214 例减少到 2015 年的 2958 例,减少了 43%。然而,在研究期间,与总吊带放置数量相比,吊带修复的比率保持稳定。SUI 网片吊带使用的上升和下降主要是由非 FPMRS 提供者驱动的。FPMRS 提供者实施了更高比例的吊带手术。FPMRS 医生的数量也从 2011 年增加到 2015 年,每位医生的吊带放置和修复中位数病例量更高。
在纽约州,自 2011 年 FDA 发布公共卫生通知以来,用于 SUI 的网片吊带的使用率显著下降,而在这种情况下,网片的使用没有任何特定的警告。这一趋势主要是由于非 FPMRS 医生中网片使用率的下降所致,尽管具体的因果关系可能很复杂。