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Why the FDA took 23 years to warn about morcellators

from Medscape

A new government study sheds light on why the US Food and Drug Administration took 23 years to warn physicians and patients about the potentially fatal risks of power morcellators used in gynecologic procedures after the first device was approved in 1991. A member of Congress who asked the Government Accountability Office (GAO) to investigate this time lag said that the study identified "serious gaps" in the FDA's system for detecting postmarket problems with medical devices. more


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