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Changes in Myomectomy Practice After the U.S. Food and Drug Administration Safety Communication on Power Morcellation
Natalie C Stentz1, Laura G Cooney, Mary Sammel
1University of Pennsylvania, Philadelphia, Pennsylvania.
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.
Insights
The 2014 U.S. Food and Drug Administration (FDA) safety communication led to more abdominal myomectomies. Despite higher morbidity with abdominal surgery, overall patient morbidity after myomectomy did not significantly change.
Area of Science:
- Gynecology
- Surgical Outcomes
- Public Health Policy
Background:
- The U.S. Food and Drug Administration (FDA) issued a safety communication regarding power morcellation in 2014.
- Myomectomy, a surgical procedure to remove uterine fibroids, can be performed via abdominal or laparoscopic approaches.
Purpose of the Study:
- To investigate the impact of the 2014 FDA safety communication on the choice of surgical approach for myomectomy.
- To assess changes in surgical morbidity following myomectomy in relation to the FDA communication.
Main Methods:
- Retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program database.
- Comparison of myomectomies performed before (April 2012-December 2013) and after (April 2014-December 2015) the FDA communication.
- Statistical analysis using regression models to compare surgical approaches and associated morbidity, adjusting for patient and fibroid characteristics.
Main Results:
- Post-FDA communication, abdominal myomectomy rates increased significantly (60.0%) compared to pre-FDA (49.1%).
- Abdominal myomectomy was consistently associated with longer hospitalizations, higher readmissions, and greater morbidity than laparoscopic myomectomy.
- Despite the shift towards abdominal procedures, overall composite morbidity after myomectomy remained similar between the pre-FDA and post-FDA periods.
Conclusions:
- The FDA safety communication on power morcellation was associated with an 11% absolute increase in abdominal myomectomy use.
- Increased reliance on abdominal myomectomy did not lead to clinically significant changes in overall patient morbidity.
- Surgical approach choice is influenced by safety communications, but patient outcomes may not change significantly if other factors are controlled.
