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Change in Surgical Practice for Women With Leiomyomas After the U.S. Food and Drug Administration Morcellator Safety Communication

Clark, Nina M. BS; Schembri, Michael BS; Jacoby, Vanessa L. MD, MAS

doi: 10.1097/AOG.0000000000002309
Contents: Original Research

OBJECTIVE: To evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas.

METHODS: This is a cross-sectional study using data from 2013 to 2014 in the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgical Databases from Arizona, Florida, Kentucky, and New Jersey. Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis. Multivariable models were used to assess changes in the proportion of hysterectomies performed laparoscopically, vaginally, or by laparotomy in the 15 months before the FDA safety communication in April 2013 (January 2013 to March 2014) to the 9 months after the FDA communication (April to December 2014). Changes in the proportion of women who underwent myomectomy compared with hysterectomy were also evaluated during this time period.

RESULTS: There were 77,637 hysterectomy and myomectomy cases analyzed from states with both inpatient and ambulatory surgery data; 59% of patients were outpatients. Overall, there was a 4% (95% CI 3.2–4.8%) decrease in the use of laparoscopic hysterectomy for treatment of uterine leiomyomas from 62% of all hysterectomies before the FDA communication on morcellation to 58% afterward. Changes in surgical practice were more pronounced in the inpatient compared with outpatient setting; inpatient laparoscopic hysterectomy decreased by 7% (95% CI 6.1–7.9%) from 24% to 17% of all hysterectomies with an accompanying increase in abdominal hysterectomy of 8% (95% CI 6.7–8.6%) from 71% to 79%. There were no significant changes in the proportion of women with leiomyomas who underwent myomectomy compared with hysterectomy.

CONCLUSION: The FDA communication discouraging the use of power morcellators was associated with a decline in laparoscopy to perform hysterectomy, particularly in the inpatient setting. There was no change in the selection of myomectomy compared with hysterectomy for leiomyoma treatment after the FDA communication.

The U.S. Food and Drug Administration communication on power morcellation to remove uterine leiomyomas was associated with a decline in the use of laparoscopic hysterectomy, particularly in the inpatient setting.

University of California, San Francisco School of Medicine, and the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, California.

Corresponding author: Vanessa L. Jacoby, MD, MAS, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, 550 16th Street, San Francisco, CA 94158; email: Vanessa.jacoby@ucsf.edu.

Supported by the UCSF PROF-PATH program through R25MD006832 from the National Institute on Minority Health and Health Disparities.

Financial Disclosure Mr. Schembri and Dr. Jacoby have received funding from Halt Medical for an investigator-initiated grant to support the ULTRA study of women with leiomyomas undergoing laparoscopic radiofrequency ablation. The other author did not report any potential conflicts of interest.

The authors thank Dr. Eric Vittinghoff for his assistance with the preparation of this manuscript.

Each author has indicated that he or she has met the journal's requirements for authorship.

© 2017 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.