Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation

Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroids: an updated decision analysis following the 2014 Food and Drug Administration safety communications

“…These communications resulted in significant changes in practice patterns among gynecologic surgeons 2,3 and increasing rates of abdominal hysterectomy (AH), 4 possibly leading to more complications for patients. 5,6 We previously published a decision analysis that attempted to incorporate risks associated with AH and laparoscopic hysterectomy (LH) using estimates of LMS available to the FDA at the time of the initial communications.…”

Temporal trends in minimally invasive myomectomy before and after the US Food and Drug Administration recommendation against electric morcellation

“…The US Food and Drug Administration (FDA) issued a recommendation in April 2014 discouraging the use of electric morcellation, and a warning in November 2014 against the use of electric morcellation in women undergoing myomectomy for uterine leiomyomas. Following these recommendations, independent investigators have reported decreased rates of minimally invasive myomectomy and hysterectomy, and a corresponding increase in laparotomies . However, these trends were based on surveys and assessments of state and national databases, which might not account for individual or institutional variations in surgical technique.…”

“…Following these recommendations, independent investigators have reported decreased rates of minimally invasive myomectomy and hysterectomy, and a corresponding increase in laparotomies . However, these trends were based on surveys and assessments of state and national databases, which might not account for individual or institutional variations in surgical technique. There is a dearth of data pertaining to single‐center or single‐surgeon trends in minimally invasive myomectomy after the FDA warning.…”

Patients' Knowledge and Perceptions of Morcellation

“…Practice patterns have changed as a result of this controversy, including a decline in the use of power morcellation and an increased use of laparotomy. 3–5 …”

“…In a survey of AAGL Advancing Minimally Invasive Gynecologic Surgery Worldwide and the American College of Obstetricians and Gynecologists Collaborative Ambulatory Research Network (ACOG CARN) members, 74.6% of physicians reported that 50% or less of their patients had heard about the FDA warnings against power morcellation. 5 However, this was an estimate made by providers and not a direct assessment of patient knowledge. Further characterization of patient knowledge regarding morcellation is needed to optimize patient counseling and education.…”