Ellington David R, Richter Holly E
Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35233, USA.
Obstet Gynecol Int. 2013;2013:356960. doi: 10.1155/2013/356960. Epub 2013 Aug 28.
Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy.
合成阴道网片已被用于治疗盆腔器官脱垂十余年。在此期间，随着这些装置使用的增加，不良事件报告也增多了。2008年，美国食品药品监督管理局（FDA）发布公共卫生通知，告知医生和患者对合成阴道网片使用的担忧日益增加。此后不久，在制造商和用户器械经验（MAUDE）数据库中不良事件报告显著增加的同时，FDA发布了一份关于泌尿妇科手术网片使用的安全通讯。在这份报告之后，随着医疗行业产品召回增加、医疗法律问题日益突出、患者安全问题以及临床实践争议不断，许多妇科医生和盆腔重建外科医生面临长期数据有限、临床指导不足以及对合成阴道网片在盆腔器官脱垂治疗中作用的不确定性不断增加的问题。本文采用循证方法回顾了合成阴道网片已报道的并发症，并针对其在争议中未来的使用作用提供了建议性指导。
