Shiley saga leads to improved communication.
Certain heart valves manufactured by Shiley, Inc., turned out to have increased fracture rates. Alerting doctors and patients to this problem has changed the way FDA expects manufacturers to communicate significant risks with medical devices.
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D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D017007:Duty to Warn / Q000331:legislation & jurisprudence; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration