Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, and the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, and the Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.
Obstet Gynecol. 2019 Oct;134(4):745-752. doi: 10.1097/AOG.0000000000003488.
To assess the effects of the U.S. Food and Drug Administration (FDA) safety communication and the reclassification of transvaginal mesh to a class III device on national trends in the treatment of apical prolapse.
A retrospective cohort study of surgical cases from 2008 to 2017 from the American College of Surgeons National Surgical Quality Improvement Program was conducted. Patients were included if they underwent apical prolapse repair, as identified by Current Procedural Terminology codes.
We identified 36,523 eligible surgical cases. There were no clinically meaningful differences in postoperative complications when stratified by surgical approach. The use of transvaginal mesh decreased from 35.0% to 11.0% from 2008 to 2017. In the year immediately after the first FDA safety communication in 2011, there was a decrease in the proportion of apical procedures using transvaginal mesh of 4.4% per quarter (P<.001), and the proportion of intraperitoneal, extraperitoneal, and abdominal colpopexy all increased. The greatest increase was seen for abdominal colpopexy procedures, which rose by 2.6% per quarter (P<.001). In the year after the FDA reclassification of transvaginal mesh in 2016, there was no significant change in the proportion of apical procedures using transvaginal mesh (P=.56).
The first FDA safety communication in 2011 was associated with a significant decline in the use of transvaginal mesh and a concurrent rise in abdominal colpopexy procedures using transabdominal mesh. We speculate that the 2019 FDA ban of transvaginal mesh will result in an even more substantial shift toward abdominal colpopexy procedures.
评估美国食品和药物管理局（FDA）的安全通报以及将阴道网片重新分类为 III 类器械对全国顶端脱垂治疗趋势的影响。
对 2008 年至 2017 年美国外科医师学会国家外科质量改进计划的手术病例进行回顾性队列研究。如果患者接受了顶端脱垂修复术（通过当前程序术语代码识别），则将其纳入研究。
我们确定了 36523 例符合条件的手术病例。按手术方式分层，术后并发症无明显差异。2008 年至 2017 年，阴道网片的使用从 35.0%降至 11.0%。在 2011 年首次 FDA 安全通报后的第一年，每季度使用阴道网片进行顶端手术的比例下降了 4.4%（P<.001），而经腹腔、经腹膜外和腹式子宫脱垂固定术的比例均增加。腹式子宫脱垂固定术的增幅最大，每季度增加 2.6%（P<.001）。在 2016 年 FDA 将阴道网片重新分类后的一年中，使用阴道网片进行顶端手术的比例没有显著变化（P=.56）。
2011 年首次 FDA 安全通报与阴道网片使用的显著下降以及经腹网片腹式子宫脱垂固定术的同时增加相关。我们推测，2019 年 FDA 禁止使用阴道网片将导致腹式子宫脱垂固定术的比例甚至更大幅度的转移。
