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Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive
Kenneth I Barron1, Tere Richard, Patricia S Robinson
1Advanced and Minimally Invasive Gynecology, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education, and the Center for Women's and Children's Research and Outcomes, Florida Hospital, and the Department of Obstetrics and Gynecology, University of Central Florida College of Medicine, Orlando, Florida.
Objective:
To evaluate whether there was a change in surgical practice immediately after the U.S. Food and Drug Administration (FDA) warning statement discouraging the use of power morcellation in the surgical treatment of uterine leiomyomas.
Methods:
We performed a time-series analysis. Surgical case logs from the Florida Hospital operating room documentation system were used to retrospectively identify patients who underwent a hysterectomy or myomectomy between August 1, 2013, and December 31, 2014. Cases performed during the 8 months before the FDA announcement on April 17, 2014, were compared with cases performed during the 8 months after the FDA announcement. Six hospitals and 98 surgeons were included. We compared the proportion of minimally invasive surgery cases (vaginal, laparoscopic, or robotic-assisted) for each study period.
Results:
There was a 5.8% decrease in minimally invasive hysterectomies after the FDA warning statement (85.7% [1,451/1,694] compared with 79.9% [1,350/1,690]; P<.001) and an 8.7% decrease when oncologist cases were excluded (90.2% [985/1,092] compared with 81.5% [834/1,023]; P<.001). There was a 19% decrease in minimally invasive myomectomies (62.7% [64/102] compared with 43.7% [38/87]; P=.009). Analysis by subspecialty showed a significant decrease in minimally invasive hysterectomies by obstetrician-gynecologists (ob-gyns) and minimally invasive gynecologic specialists but not urogynecologists or oncologists and a significant decrease in minimally invasive myomectomies by reproductive endocrinologists and minimally invasive gynecologic specialists but not ob-gyns.
Conclusion:
There was a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation.
Level Of Evidence:
II.
Insights
The U.S. Food and Drug Administration (FDA) warning on power morcellation led to fewer minimally invasive hysterectomies and myomectomies. Surgical practices shifted away from these procedures following the FDA
Area of Science:
- Gynecologic Surgery
- Surgical Safety
- Public Health Policy
Background:
- Uterine leiomyomas are common benign tumors.
- Power morcellation has been used for minimally invasive hysterectomy and myomectomy.
- Concerns exist regarding the potential for occult cancer spread with power morcellation.
Purpose of the Study:
- To assess changes in surgical practice after the FDA issued a warning against power morcellation.
- To evaluate the impact of the FDA warning on minimally invasive procedures for uterine fibroids.
Main Methods:
- Retrospective time-series analysis of surgical case logs.
- Comparison of hysterectomy and myomectomy cases before and after the FDA warning (April 2014).
- Analysis of minimally invasive surgery (MIS) proportions and subspecialty trends.
Main Results:
- A significant decrease in minimally invasive hysterectomies (5.8%) and myomectomies (19%) was observed post-FDA warning.
- Reductions in MIS were noted across various subspecialties, with variations among obstetrician-gynecologists, gynecologic specialists, and reproductive endocrinologists.
- Exclusion of oncologist cases showed an 8.7% decrease in minimally invasive hysterectomies.
Conclusions:
- The FDA warning statement significantly reduced the use of minimally invasive hysterectomies and myomectomies.
- Surgical trends shifted following the FDA's guidance on power morcellation.
- The findings highlight the impact of regulatory warnings on surgical practice patterns.
