Changes in Myomectomy Practice After the U.S. Food and Drug Administration Safety Communication on Power Morcellation

Abstract

Objective: To examine the association between the 2014 U.S. Food and Drug Administration (FDA) safety communication on power morcellation and surgical approach and morbidity after myomectomy.

Methods: In this retrospective cohort study, data were abstracted from the American College of Surgeons National Surgical Quality Improvement Program database on 3,160 myomectomies between April 2012 and December 2013 (pre-FDA) and 4,378 between April 2014 and December 2015 (post-FDA). Aims were to 1) compare rates of abdominal and laparoscopic myomectomy pre-FDA and post-FDA (primary outcome), 2) directly compare the morbidity of abdominal and laparoscopic myomectomy during each time period (secondary outcome 1), and 3) compare the morbidity after all myomectomies performed pre-FDA and post-FDA (secondary outcome 2). Adjusted means, odds ratios, and rate ratios with 95% confidence intervals were calculated using linear, logistic, and Poisson regression, respectively, adjusting for age, race, ethnicity, body mass index, and myoma burden.

Results: Myomectomies performed post-FDA were more likely to be abdominal (60.0%, 95% confidence interval [CI] 58.6-61.5%) than laparoscopic (40.0%, 95% CI 38.5-41.4%) as compared with myomectomies pre-FDA, which were equally divided between surgical approaches (49.1% abdominal, 95% CI 47.4-50.9% compared with 50.9% laparoscopic, 95% CI 49.1-52.6%; P<.001). When directly compared with laparoscopic myomectomy, abdominal myomectomy was associated with longer hospitalizations, higher readmission rates, and greater morbidity both pre-FDA and post-FDA (P<.05, all comparisons). Adjusted models demonstrated shorter operative times post-FDA for all myomectomies (P<.001), although composite morbidity was similar between myomectomies performed pre-FDA and post-FDA (P=.809).

Conclusions: The FDA safety communication on power morcellation was associated with an 11% absolute increase in the use of abdominal myomectomy. Although morbidity is consistently higher after abdominal as compared with laparoscopic myomectomy, the increased reliance on abdominal myomectomy post-FDA did not result in clinically significant changes in morbidity in this cohort.

Fig. 1.

Surgical approach by percentages of all myomectomies by annual quarter, 2012–2015. Laparoscopic (blue line) and abdominal (red line) myomectomy were used comparably until quarter 2 of 2014 after which significantly more myomectomies were performed using the abdominal approach (P<.001). Gray box corresponds to washout period for analysis, January to March 2014. *Wall Street Journal (WSJ) communication December 18, 2013. ^†U.S. Food and Drug Administration (FDA) safety communication April 17, 2014.