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[Chronicle of a defective heart valve prosthesis]
Y van der Graaf1, M Kallewaard, A Algra
1Julius Centrum voor Patiëntgebonden Onderzoek, TA Utrecht.
Nederlands Tijdschrift Voor Geneeskunde
|October 9, 1998
Abstract:
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.