April 11, 2018

Hysterectomy complication rates after FDA warning against power morcellation

By: Judy Mathias

Editor's Note

In this study, 30-day complications rates increased after the Food and Drug Administration (FDA) warned against the use of power morcellation in women undergoing hysterectomy for benign gynecologic indications.

In a cohort of 75,487 women who had hysterectomies, statistically and clinically significant increases in major (1.9% to 2.4%) and minor complications (2.7% to 3.3%) occurred after the FDA warning in a subset of 25,571 women with uterine fibroids.

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In this subgroup, the rate of open abdominal surgery also increased from 37.2% to 43.0%, and the rate of minimally invasive surgery decreased from 56.1% to 49.7%.

The potential harm associated with decreased rates of minimally invasive surgery following reduced morcellation use should be considered by clinicians and patients during decision making and by regulatory bodies and medical societies issuing communications on minimally invasive hysterectomy and morcellation, the authors say.


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