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U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It
William H Parker1, Andrew M Kaunitz, Elizabeth A Pritts
1UCLA 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.
Abstract:
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.