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Research Letter |

Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Prolapse

Art Sedrakyan, MD, PhD1; Bilal Chughtai, MD2; Jialin Mao, MD, MSc1
[+] 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.
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This study uses New York Statewide Planning and Research Cooperative System data to determine the extent of use of vaginal mesh in pelvic organ prolapse after the most recent FDA warning.

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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Trends in Use of Mesh in Pelvic Organ Prolapse Repair Surgery Between 2011 and 2013 in New York State

Percentages (with 95% CIs) of procedures using mesh for repair of pelvic organ prolapse repair and by hospital procedure volume and teaching status.

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Use of Surgical Mesh in Pelvic Organ Prolapse Surgery in the United States in 2007-2014
Posted on February 14, 2016
Andrew Yoo, MD, Piet Hinoul, MD, Myoung Kim, PhD
Johnson and Johnson; Ethicon, Inc
Conflict of Interest: Andrew Yoo and Myoung Kim are employees of Johnson and Johnson; Piet Hinoul is an employee of Ethicon, Inc a subsidiary of Johnson and Johnson
We appreciate the letter by Sedrakyan et al1 and would like to add to this discussion by sharing the findings from our analysis of a more broadly-based U.S. data derived from the Truven MarketScan® Commercial & Medicare Supplemental Database (Truven Health Analytics, Ann Arbor, MI), which is a large insurance database containing reimbursement claims for over 100 million people.
Our analysis utilized the same set of ICD-9 and CPT-4 codes provided by Chughtai et al2 in Appendix A. We tried to identify the “first” POP surgery events for individual patients by imposing a minimum 1-year washout period of continuous enrollment and then excluding patients with prior POP surgery during the washout period.
This analysis also shows a similar national increasing trend in the share of mesh based POP surgery from 2007 through 2010 and then a steady decline every year until the end of the last observation period, 2014 (partial year, first 9 months). Indeed, the share of mesh based POP surgery was substantially lower in 2014 (17.6%) than in 2007 (28.5%), by more than 10 percentage points (a net 38% decrease).The yearly proportion and 95% CI are: 2007 (0.285[0.278,0.292]), 2008 (0.332[0.324,0.339]), 2009 (0.334[0.327,0.341]), 2010 (0.345[0.338,0.352]), 2011 (0.311[0.304,0.317]), 2012 (0.240[0.234,0.236]), 2013 (0.204[0.198,0.210]), and 2014 (0.176[0.168,0.183]).
This continuous downward trend since 2010 in POP mesh utilization is likely the result of several factors, one of which may be that the medical community has been responding to regulatory warnings by becoming increasingly more judicious in their use of mesh products in POP surgery, in line with the degree of warning. We believe this additional analysis complements the findings from Sedrakyan et al by adding broader national data

1. Sedrakyan A, Chughtai B, Mao J. Regulatory warnings and use of surgical mesh in pelvic organ prolapse. JAMA Int Med. 2016;176:2.

2. Chughtai B, Mao J, Buck J, Kaplan S, Sedrakyan A. Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study. BMJ. 2015;350:h2685.
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