Unger Cecile A, Barber Matthew D
Center for Urogynecology and Pelvic Reconstructive Surgery, Obstetrics, Gynecology, & Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.
Clin Obstet Gynecol. 2015 Dec;58(4):740-53. doi: 10.1097/GRF.0000000000000148.
In 2001, the Food and Drug Administration approved the first surgical mesh product specifically designed for the surgical repair of pelvic organ prolapse and between 2004 and 2008, the use of vaginal mesh in gynecologic surgery was at its peak. Unfortunately, the rise in transvaginal mesh use was accompanied by a surge of adverse events and mesh-related complications. As a result, the Food and Drug Administration put forth several efforts to regulate the manufacturing of vaginal mesh products. These notifications have been supported by several gynecologic societies, and recommendations now exist not only on the placement of mesh and patient selection, but also on the evaluation and management of mesh-related complications. In addition, data on outcomes following management of these complications are now emerging.
2001年，美国食品药品监督管理局批准了首款专门用于盆腔器官脱垂手术修复的外科网片产品。在2004年至2008年期间，阴道网片在妇科手术中的使用达到了顶峰。不幸的是，经阴道网片使用的增加伴随着不良事件和与网片相关并发症的激增。因此，美国食品药品监督管理局采取了多项措施来规范阴道网片产品的生产。这些通知得到了多个妇科协会的支持，现在不仅有关于网片放置和患者选择的建议，还有关于与网片相关并发症的评估和管理的建议。此外，关于这些并发症处理后结果的数据现在也开始出现了。
