To analyze utilization of, and payments for, pelvic organ prolapse procedures after the 2011 U.S. Food and Drug Administration (FDA) communication regarding transvaginal mesh.
This is a retrospective cohort study examining private claims from three insurance providers for inpatient and outpatient prolapse procedures from 2010 to 2013 in the Health Care Cost Institute. Primary outcomes were the change in utilization of prolapse procedures, with and without mesh, before and after the July 2011 FDA communication. Secondary outcomes were the changes in payments and reimbursements for these procedures. Utilization rates and payments were compared using generalized linear models and interrupted time-series analysis.
Utilization of prolapse procedures decreased from 12.3 to 9.7 per 10,000 woman-years (P=.027) with a decrease of 30.7% (3.9 in 2010 to 2.7 in 2013, P=.05) in number of mesh procedures and 16.6% (8.4 in 2010 to 7.0 in 2013, P=.011) for nonmesh procedures. Quarterly utilization of mesh procedures was increasing before the FDA communication and then significantly declined after its release (slope=0.024 vs −0.025, P=.002). Nonmesh procedures, however, were already slightly decreasing before July 2011 and continued to decline at a more rapid pace after that time, although not significantly (slope=−0.004 vs −0.022, P=.47). Inpatient utilization decreased 52.2% (P=.002), whereas outpatient utilization increased 18.5% (P=.132). Payments for individual inpatient procedures, with and without mesh, increased by 12.0% ($8,315 in 2010 to $9,315 in 2013, P=.001) and 15.6% ($7,826 in 2010 to $9,048 in 2013, P=.005), respectively, whereas those for outpatient procedures increased by 41% ($4,961 in 2010 to $6,981 in 2013, P=.006) and 30% ($3,955 in 2010 to $5,149 in 2013, P=.004), respectively.
Use of prolapse surgery declined during the study period. After the 2011 FDA communication regarding transvaginal mesh, there was a significant decrease in the utilization of procedures with mesh but not for those without mesh. A shift toward outpatient surgeries was observed, and payments for both individual inpatient and outpatient cases increased.
Utilization of prolapse procedures in a privately insured population declined between 2010 and 2013, regardless of mesh use, whereas individual procedure payments increased.
Departments of Obstetrics and Gynecology and Cardiovascular Medicine, Michigan Medicine, and the Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan.
Corresponding author: Anne G. Sammarco, MD, MPH, 1500 E Medical Center Drive, Ann Arbor, MI 48109; email: firstname.lastname@example.org.
Investigator support for Dr. Swenson was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development WRHR Career Development Award # K12 HD065257 and for Dr. DeLancey by the Office for Research on Women's Special Center of Research P50 HD044406.
Financial Disclosure The authors did not report any potential conflicts of interest.
Presented as a poster at the American Urogynecologic Society meeting, September 27–October 1, 2016, Denver, Colorado.
Each author has indicated that he or she has met the journal's requirements for authorship.