Bioethics News

Whistleblower Case Contends Surgical Device Maker Misled FDA — And Patients Paid the Price

August 15, 2016

(STAT News) – Medical devices are lightly regulated by the FDA, and once they have been cleared by the agency, physicians may use them however they see fit. But patient advocates and others say the story of the Medtronic implant is a cautionary tale when it comes to medical device safety. The case, they say, is only the latest in which a manufacturer is alleged to have promoted its devices for unapproved or “off-label” uses, despite regulations prohibiting them from doing so.

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