Document Detail

Approval process for devices and mesh for surgical treatment of pelvic organ prolapse and urinary incontinence.
MedLine Citation:
PMID:  23632639     Owner:  NLM     Status:  In-Data-Review    
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.
Ingrid Nygaard
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical obstetrics and gynecology     Volume:  56     ISSN:  1532-5520     ISO Abbreviation:  Clin Obstet Gynecol     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-05-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0070014     Medline TA:  Clin Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  229-31     Citation Subset:  IM    
Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery, University of Utah School of Medicine, Salt Lake City, Utah.
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