[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.
Julius Centrum voor Patiëntgebonden Onderzoek, TA Utrecht.
Y
Y
van der Graaf
M
M
Kallewaard
A
A
Algra
D003219:Confidentiality; D004992:Ethics, Medical; D005260:Female; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D016365:Liability, Legal; D008297:Male; D009426:Netherlands; D018579:Patient Selection; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
Kroniek van een ondeugdelijke hartklepprothese.