U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?. Issue 1 (January 2016)

• Record Type: Journal Article
• Authors: Parker, William H.; Kaunitz, Andrew M.; Pritts, Elizabeth A.; Olive, David L.; Chalas, Eva; Clarke-Pearson, Daniel L.; Berek, Jonathan S.
• Is Part Of: Obstetrics and gynecology. Volume 127:Issue 1(2016)
• Publication Date: 2016-01
• Subjects: Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1097/AOG.0000000000001157
• Languages: English
• ISSNs: 0029-7844

Abstract

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. Abstract : 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.