ACOG Statement: FDA Issues Safety Communication on Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy
Today, the Food and Drug Administration released a safety communication
regarding uterine power morcellation in hysterectomy and myomectomy (April 17, 2014). The American College of Obstetricians and Gynecologists is currently undertaking a thorough and deliberate review of the published scientific literature about power morcellation and malignancy in gynecologic surgery. We greatly appreciate the urgency behind this issue. As part of its mission, the College carefully considers emerging clinical and scientific advances, as well as newly available data, to provide the medical community with the best available evidence-based guidance for obstetric and gynecologic practice that enhances the care provided to patients.
As the College conducts our review, we are evaluating the incidence of undiagnosed uterine sarcomas. The resulting estimate will take into account variables such as sample size, age, patient risk factors, and the occurrence of malignancy.
Ob-gyns remain focused on providing safe, high-quality care to America’s women. With that in mind, it is important for each patient and her doctor to communicate fully about the risks and benefits of all procedures, including surgical options, so that she is able to make an informed and voluntary decision about the care that she receives.
On November 24, 2014, the College issued a statement on morcellation, based on the FDA’s updated safety statement on Uterine Power Morcellation in Hysterectomy and Myomectomy.