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WASHINGTON (AP) - A Los Angeles-area doctor who lent his name to a type of stomach-shrinking surgery failed to obtain the full informed consent of 175 patients implanted with an experimental medical device, according to a federal warning letter released Tuesday.
Dr. Mathias A.L. Fobi also implanted 185 patients with an experimental device before receiving approval to do so from either the Food and Drug Administration or the institutional review board overseeing the study, amid other violations of federal regulations, according to the Jan. 24 letter. The FDA posted a largely blacked-out copy of the letter to its Web site on Tuesday.
The copy did not make clear if the same device was used in all the patients.
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