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Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ

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Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Letters implementing strategies to promote more judicious use of CT. of pelvic organ prolapse and reported 1503 mesh-related Efforts by policy makers and medical-center leaders to re- events (5-fold increase) in the Manufacturer and User Device align incentives that promote the escalating use of CT remain Experience database from January 1, 2008, through Decem- a societal imperative. ber 31, 2010.2 We sought to determine the extent of use of vaginal mesh in pelvic organ prolapse after the most recent Frank S. Drescher, MD FDA warning and patterns of discontinuation of the use of Brenda E. Sirovich, MD, MS vaginal mesh in New York State. Author Affiliations: Outcomes Group, VA Medical Center, White River Junction, Methods | We used data from the New York Statewide Plan- Vermont (Drescher, Sirovich); Medicine, Geisel School of Medicine at ning and Research Cooperative System, which contains rec- Dartmouth, Hanover, New Hampshire (Drescher, Sirovich); Pulmonary and Critical Care Medicine, Veterans Affairs, White River Junction, Vermont ords of all surgical procedures done in the state. Patients un- (Drescher); The Dartmouth Institute for Health Policy and Clinical Practice, dergoing surgical procedures for pelvic organ prolapse with or Hanover, New Hampshire (Sirovich). without the use of mesh from January 1, 2011, to December 31, Corresponding Author: Frank S. Drescher, MD, Pulmonary and Critical Care 2013, were identified through previously described methods.3 Medicine, Veterans Affairs, 215 N Main St (111), White River Junction, VT 05009 ([email protected]). Patients with previous repairs of prolapse were excluded. The average annual hospital volume of prolapse repair surgery was Published Online: December 28, 2015. doi:10.1001/jamainternmed.2015.7098. categorized into tertiles. The teaching status of a particular hos- Author Contributions: Dr Drescher had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data pital was obtained by linking to the American Hospital Asso- analysis. ciation database. We evaluated trends in the use of vaginally Study concept and design: Both authors. placed mesh both overall and stratified by hospital volume and Acquisition, analysis, or interpretation of data: Both authors. Drafting of the manuscript: Drescher. teaching status. We calculated estimates and 95% CIs and ob- Critical revision of the manuscript for important intellectual content: Sirovich. tained 95% CIs for zero-frequency cells with the method in- Statistical analysis: Drescher. troduced by Hanley and Lippman-Hand.4 Administrative, technical, or material support: Drescher. This study was approved by the Weill Cornell Medical Col- Study supervision: Sirovich. lege Institutional Review Board. Conflict of Interest Disclosures: None reported. Funding/Support: Dr Drescher was supported by a Veterans Integrated Service Network 1 (VA New England) Career Development Award. Results | The annual number of repair procedures for pelvic or- gan prolapse decreased from 6960 in 2011 to 5757 in 2013. The Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of use of mesh after the 2011 FDA warning declined from 30% the data; preparation, review, or approval of the manuscript; and decision to (95% CI, 29%-31%) to 23% (95% CI, 22%-24%) in 2013, with the submit the manuscript for publication. decrease being more pronounced in low-volume than in high- Disclaimer: The views expresed herein do not necessarily represent the views volume centers (from 25% [95% CI, 23%-27%] to 15% [95% CI, of the Department of Veterans Affairs or the US government. 13%-16%] vs from 37% [95% CI, 35%-39%] to 34% [95% CI, 32%- Previous Presentation: This study was presented as a poster at the American 36%]; P < .01) (Figure). The decrease was also more dramatic Thoracic Society International Conference; May 19, 2014; San Diego, California. in nonteaching than in teaching facilities (from 29% [95% CI, 1. Huppmann MV, Johnson WB, Javitt MC. Radiation risks from exposure to chest computed tomography. Semin Ultrasound CT MR. 2010;31(1):14-28. 27%-30%] to 20% [95% CI, 18%-21%] vs from 32% [95% CI, 31%- 2. Miglioretti DL, Smith-Bindman R. Overuse of computed tomography and 34%] to 27% [95% CI, 25%-29.0%]; P < .01). associated risks. Am Fam Physician. 2011;83(11):1252-1254. Eighty-eight physicians performed at least 5 prolapse 3. Kocher KE, Meurer WJ, Fazel R, Scott PA, Krumholz HM, Nallamothu BK. repair procedures annually during the 3-year period covered National trends in use of computed tomography in the emergency department. in the study and used mesh in the year 2011. In 2012, a total Ann Emerg Med. 2011;58(5):452-62.e3. of 14 physicians, consisting of hospitals and outpatient sur- 4. Sirovich BE, Woloshin S, Schwartz LM. Too little? too much? primary care gical centers stopped using mesh, followed by another 8 in physicians’ views on US health care: a brief report. Arch Intern Med. 2011;171(17): 1582-1585. 2013 (Table). In terms of pelvic organ prolapse procedures 5. ABIM Foundation. Choosing Wisely: an Initiative of the ABIM Foundation. performed, most of these institutions were low-volume http://www.choosingwisely.org/. Published August 15, 2014. facilities. 6. American College of Radiology. ACR Appropriateness Criteria. http://www.acr .org/Quality-Safety/Appropriateness-Criteria. Published August 15, 2014. Discussion | We found that after the 2011 FDA warning, mesh use decreased from 30% in 2011 to 23% in 2013. In a prior analy- Regulatory Warnings and Use of Surgical Mesh sis covering the period after the first FDA warning in 2008, we in Pelvic Organ Prolapse found that mesh use increased from 21% in 2008 to 30% in In 2002, the US Food and Drug Administration (FDA) 2011.3 The FDA message in 2008 urged physicians to obtain approved mesh for the surgical treatment of pelvic organ specialized training for each technique in which mesh was used prolapse and in 2008 released a public health notification of and to be aware of risks associated with the use of mesh. The risks associated with this 2011 FDA communication included stronger language about use of surgical mesh.1 In complications of the use of mesh, describing them as “not rare” Invited Commentary page 277 2011, the FDA released an on the basis of an internal systematic review. The FDA also updated communication questioning the effectiveness of stated that pelvic organ prolapse could be repaired without vaginally placed mesh as compared with the nonmesh repair mesh and provided recommendations about the transvagi- jamainternalmedicine.com (Reprinted) JAMA Internal Medicine February 2016 Volume 176, Number 2 275 Copyright 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 Letters Figure. Trends in Use of Mesh in Pelvic Organ Prolapse Repair Surgery Between 2011 and 2013 in New York State 40 2011 35 2012 2013 30 25 20 15 Procedures Using Mesh, % 10 5 Percentages (with 95% CIs) of 0 procedures using mesh for repair of Overall Low Medium High Teaching Nonteaching pelvic organ prolapse repair and by Hospital Procedure Volume Type of Facility hospital procedure volume and teaching status. Table. Hospital Characteristics and Reduction in Use of Mesh for Pelvic Organ Prolapse in 2012 and 2013 Compared With 2011 No. (%) [95% CI] Stopped Using Mesh Mesh Use Decrease >50% Compared with Characteristic Total, No. 2012 2013a 2012 2013a Overall 88 14 (15.9) 22 (25.0) 24 (27.3) 40 (45.5) [9.7-25.0] [17.1-35.0] [19.1-37.4] [35.5-55.8] Hospital volume Low 57 13 (22.8) 21 (36.8) 22 (38.6) 34 (59.6) [13.8-35.2] [25.5-49.8] [27.1-51.6] [46.7-71.4] Medium 18 1 (5.6) 1 (5.6) 1 (5.6) 5 (27.8) [0.1-25.8] [0.1-25.8] [0.1-25.8] [12.5-50.9] High 13 0 0 1 (7.7) 1 (7.7) [0.0-20.6]b [0.0-20.6]b [1.4-33.3] [1.4-33.3] Teaching status Teaching 32 1 (3.1) 4 (12.5) 4 (12.5) 11 (34.4) [0.1-15.7] [5.0-28.1] [5.0-28.1] [20.4-51.7] Nonteaching 56 13 (23.2) 18 (32.1) 20 (35.7) 29 (51.8) [14.1-35.8] [21.4-45.2] [24.5-48.8] [39.0-64.3] a The number of hospitals in 2013 stopping or reducing the use of mesh include b The 95% CI is based on the method by Hanley and Lippman-Hand4 and in those who also stopped in 2012. other instances was calculated with the method of Wilson. nal repair of such prolapse for both physicians and patients. lower tolerance for litigation related to sizable awards and Although other explanations are possible, we believe that the growing numbers of lawsuits in outpatient settings.6 stronger language in the 2011 FDA warning is at least partly re- Our study is unique in including an entire state’s data and lated to the decline in mesh use and has implications for fu- a recent period in the use of mesh. However, some variability ture risk-communications policy,suggesting that stronger regu- in the use of mesh among states is possible and should be con- latory warnings can influence physicians’ use of potentially sidered when generalizing to the US population. Another limi- unsafe medical devices. tation of our study is its use of billing codes that are not spe- We also found that most of the decline in the use of cific to vaginally placed mesh.
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