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正确认识美国FDA对经阴道使用网片安全性及有效性的警示 被引量:14

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摘要 盆底功能障碍性疾病的发生率在人群中高达30%~76%,而超过50%的经产妇存在不同程度的盆腔器官脱垂(pelvic organ prolapse,POP)。妇女一生中有11.1%的风险需要行盆底修复手术,而再次手术的风险可高达13%~56%,所以,近年来盆底重建手术中补片被广泛使用,其可以加强薄弱的自身组织,恢复解剖,降低传统修复手术的复发率。
作者 杨欣 王建六
出处 《中国妇产科临床杂志》 2013年第2期97-99,共3页 Chinese Journal of Clinical Obstetrics and Gynecology
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参考文献5

  • 1Food and Drug Administration. FDA safety communication: UPDATE on serious complications associated with transvagi- nal placement of surgical mesh for pelvic organ prolapse [J/ OL]. Silver Spring (ME)) : FDA, 2011 [2013 - 1 - 5-1. http: [ /www. fda. gov/MedicalDevices/Safety/ AlertsandNo- tiees/ucm262435, htm.
  • 2Murphy M, Holzberg A, van Raalte H, et al. Time to re- think: an evidence - based response from pelvic surgeons to the FDA Safety Communication: "UPDATE on serious com- plications associated with transvaginal placement of surgical mesh for pelvic organ prolapse". Int Urogynecol J, 2012, 23: 5-9.
  • 3Committee Opinion Number 513. Vaginal placement of syn- thetic mesh for pelvic organ prolapse. Female Pelvic Med Re- constrSurg, 2012, 18: 5-9.
  • 4American Urogynecologic Society's Guidelines Development Committee. Guidelines for providing privileges and creden- tials to physicians for transvagina] placement of surgical mesh for pelvic organ prolapse. Female Pelvic Med Reconstr Surg, 2012, 18: 194-197.
  • 5Stanford E, Moen M Patient safety communication from the Food and Drug Administration regarding transvaginal mesh for pelvic organ prolapse surgery. J Minim Invasive Gynecol, 2011, 18: 689-691.

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