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.