[Chronicle of a defective heart valve prosthesis].
Copyright policy )[Chronicle of a defective heart valve prosthesis].
The Björk-Shiley convexo-concave (BScc) strut fracture problem is about to enter its third decade. At present, valve carriers still face the risk of outlet strut fracture; a risk which does not seem to decline. The temporising attitude of the manufacturer has led to far more victims than would have been necessary but also the Food and Drug Administration, regulatory agencies outside the US and the medical community share responsibility for this problem.
Male, Reoperation, United States Food and Drug Administration, Patient Selection, Heart Valve Diseases, Liability, Legal, Prosthesis Design, United States, Prosthesis Failure, Heart Valve Prosthesis, Humans, Ethics, Medical, Female, Confidentiality, Netherlands
Male, Reoperation, United States Food and Drug Administration, Patient Selection, Heart Valve Diseases, Liability, Legal, Prosthesis Design, United States, Prosthesis Failure, Heart Valve Prosthesis, Humans, Ethics, Medical, Female, Confidentiality, Netherlands
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