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U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?

Parker, William H. MD; Kaunitz, Andrew M. MD; Pritts, Elizabeth A. MD; Olive, David L. MD; Chalas, Eva MD; Clarke-Pearson, Daniel L. MD; Berek, Jonathan S. MD, MMS; for the Leiomyoma Morcellation Review Group

doi: 10.1097/AOG.0000000000001157
Contents: Current Commentary

The U.S. Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of leiomyomas because of the concern for inadvertent spread of tumor cells if an undiagnosed cancer were present. The authors, representing a 45-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to asses reliable data regarding patient survival after morcellation. The authors disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery.

The authors disagree with the U.S. Food and Drug Administration's methodology and warning against use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for leiomyomas.

UCLA School of Medicine, Los Angeles, California; the University of Florida College of Medicine, Jacksonville, Jacksonville, Florida; the Wisconsin Fertility Institute, Middleton, Wisconsin; Winthrop-University Hospital, Mineola, New York; the University of North Carolina, Chapel Hill, North Carolina; and Stanford University School of Medicine, Stanford, California.

Corresponding author: William H. Parker, MD, 1450 Tenth Street, Santa Monica, CA 90401; e-mail: wparker@ucla.edu.

Financial Disclosure Dr. Parker received consultant fees in 2014 from Ethicon, Inc., for work completed in 2011 to teach aviation safety principles to the operating room staff of Saint John's Hospital. The other authors did not report any potential conflicts of interest.

The authors thank the Leiomyoma Morcellation Review Group (Appendix 1, available online at http://links.lww.com/AOG/A721) for reviewing the initial draft of this report and providing constructive feedback. This group is comprised of clinicians, researchers, women's health care advocates, and potential users of the report. All are active professionals in the field. Members of the review group were asked to provide comments on the content, structure, and format of the evidence report and their comments and their suggestions formed the basis of our revisions to the evidence report.

© 2016 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.