Editing Functional: Female SUI (section)

====== Regulatory and Legal Issues Related to Sling Mesh Complications ======
* '''See [[AUA & CUA Mesh Position Statement (2019)|AUA/CUA Mesh Position Statements]]'''
* The success of MUSs for incontinence led to the development of mesh products for pelvic organ prolapse repair. However, while the use of mesh during pelvic organ prolapse repairs has increased, so too have complications related to its use.
* Synthetic mesh for pelvic organ prolapse
**In October 2008, the FDA released a public health notification (PHN) alerting the public about “rare” complications and problems related to transvaginal mesh products used for pelvic organ prolapse. 
**'''In 2011, the FDA''' modified this alert by removing the term “rare” and '''stating that surgical mesh for pelvic organ prolapse repair does not conclusively improve outcomes over traditional nonmesh or native tissue repairs and is associated with unique potentially serious adverse outcomes'''
* '''Synthetic mesh for midurethral slings'''
**'''FDA advisory panel deemed existing MUS products “safe and effective”'''
** Even though the FDA has determined that existing MUS products are safe and effective, this unfortunately does not prevent MUSs from being caught up in the fervor of litigation related to products used for pelvic organ prolapse repair.
** '''Single-incision sling manufacturers are required to perform 522 postmarket surveillance studies'''