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Research Letter
February 2016

Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Prolapse

Author Affiliations
  • 1Department of Healthcare Policy and Research, Weill Medical College of Cornell University, New York, New York
  • 2Department of Urology, Weill Medical College of Cornell University, New York–Presbyterian Hospital, New York
JAMA Intern Med. 2016;176(2):275-277. doi:10.1001/jamainternmed.2015.6595

In 2002, the US Food and Drug Administration (FDA) approved mesh for the surgical treatment of pelvic organ prolapse and in 2008 released a public health notification of risks associated with this use of surgical mesh.1 In 2011, the FDA released an updated communication questioning the effectiveness of vaginally placed mesh as compared with the nonmesh repair of pelvic organ prolapse and reported 1503 mesh-related events (5-fold increase) in the Manufacturer and User Device Experience database from January 1, 2008, through December 31, 2010.2 We sought to determine the extent of use of vaginal mesh in pelvic organ prolapse after the most recent FDA warning and patterns of discontinuation of the use of vaginal mesh in New York State.

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