Approval Process for Devices and Mesh for Surgical Treatment of Pelvic Organ Prolapse and Urinary Incontinence

被引：3

作者：

Nygaard, Ingrid ^{[1
]}

机构：

[1] Univ Utah, Sch Med, Dept Obstet & Gynecol, Div Urogynecol & Reconstruct Pelv Surg, Salt Lake City, UT 84132 USA

来源：

CLINICAL OBSTETRICS AND GYNECOLOGY | 2013年 / 56卷 / 02期

关键词：

pelvic organ prolapse; urinary incontinence; vaginal mesh; surgical devices; Food and Drug Administration;

D O I：

10.1097/GRF.0b013e318282f2d7

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

Most marketed devices in the United States, including most used to treat prolapse and incontinence, are marketed without FDA approval; instead, they gain "clearance'' as a class II device through premarket notification [also known as the 510(k) process]. Under this process, the manufacturer states that the device is substantially equivalent to one already on the market. Thus, mesh kits for prolapse and incontinence were not required to undergo clinical testing before reaching the market. In January 2012, the FDA announced that it would require postmarket surveillance studies to address safety and effectiveness of mesh kits for prolapse and for single-incision slings.

引用

页码：229 / 231

页数：3