Breast implants, Hippocrates, and burden of proof.
The author argues that the burden of proof for the safety and efficacy of some medical devices properly lies with the manufacturers of the devices and with the providers who use them. The controversy over breast implants is used as a case for this shift in the burden of proof of safety and effectiveness.
McGivney
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WT
D001940:Breast / Q000502:physiology / Q000601:surgery; D003257:Consumer Product Safety; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D010344:Patient Advocacy / Q000331:legislation & jurisprudence* / Q000639:trends; D011358:Product Surveillance, Postmarketing / Q000592:standards; D019736:Prostheses and Implants / Q000592:standards*; D012828:Silicones / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration