TY - JOUR
T1 - Lessons Learned from Mesh Litigation for Prolapse and Incontinence
AU - Brown, Elizabeth Timbrook
AU - Cohn, Joshua A.
AU - Kaufman, Melissa R.
AU - Reynolds, W. Stuart
AU - Dmochowski, Roger R.
N1 - Publisher Copyright:
© 2016, Springer Science+Business Media New York.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) can cause significant impairment in quality of life and lead many women to seek surgical correction. These procedures are often performed using polypropylene mesh. The Food and Drug Administration (FDA) issued a Public Health Notification to inform patients of adverse events related to the use of mesh placed in these repairs. Since this time, there have been almost 50,000 legal proceedings related to complications of polypropylene mesh in the urogynecology setting. Currently, the FDA is conducting further studies to evaluate the safety and efficacy of polypropylene mesh, but it is still available for use in the repair of SUI and POP. Thus, patients should be carefully selected and counseled appropriately regarding conservative management options and alternative surgical therapies prior to mesh placement. As a result of the FDA recommendations, researchers are currently trying to develop a treatment alternative to mesh.
AB - Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) can cause significant impairment in quality of life and lead many women to seek surgical correction. These procedures are often performed using polypropylene mesh. The Food and Drug Administration (FDA) issued a Public Health Notification to inform patients of adverse events related to the use of mesh placed in these repairs. Since this time, there have been almost 50,000 legal proceedings related to complications of polypropylene mesh in the urogynecology setting. Currently, the FDA is conducting further studies to evaluate the safety and efficacy of polypropylene mesh, but it is still available for use in the repair of SUI and POP. Thus, patients should be carefully selected and counseled appropriately regarding conservative management options and alternative surgical therapies prior to mesh placement. As a result of the FDA recommendations, researchers are currently trying to develop a treatment alternative to mesh.
KW - FDA safety notification
KW - Mesh kits
KW - Mesh litigation
KW - Pelvic organ prolapse
KW - Stress urinary incontinence
KW - Transvaginal mesh
UR - http://www.scopus.com/inward/record.url?scp=84961671492&partnerID=8YFLogxK
U2 - 10.1007/s11884-016-0353-8
DO - 10.1007/s11884-016-0353-8
M3 - Review article
AN - SCOPUS:84961671492
SN - 1931-7212
VL - 11
SP - 73
EP - 78
JO - Current Bladder Dysfunction Reports
JF - Current Bladder Dysfunction Reports
IS - 1
ER -