Conference Coverage

Survey: Litigation fears drive response to FDA power morcellator warnings



– A 2014 Food and Drug Administration Safety Communication warning about the risk of disseminating occult cancerous tissue when using power morcellation led to a sharp decline in its use among physicians in a large health care system, a survey and records review showed.

Dr. Gerald Bernard Taylor, Carolinas Health System, charlotte, NC Sharon Worcester/MDedge News

Dr. Gerald Bernard Taylor

Survey responses indicated that the reaction to the communication, which specifically warned against power morcellation for hysterectomy or myomectomy for uterine fibroids, was driven far more by fears of litigation than by concerns about the safety of power morcellation.

Of 126 ob.gyns. in the Charlotte, N.C., metro area who received the 24-question e-mail survey, 58% responded, and while 75% reported that they always or sometimes used power morcellation prior to receiving the FDA communication, more than 80% reported rarely or never using it after receiving the communication, Gerald Bernard Taylor, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Fear of litigation was cited as the reason for the change in practice by 45.7% of ob.gyns., followed by lack of access to power morcellators (34.7%), and concerns about undiagnosed malignancy (11.8%) and patient safety (5.7%), said Dr. Taylor of the Carolinas HealthCare System in Charlotte.


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