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The Arts and Medicine
July 16, 2019

The Bleeding Edge: Documenting Innovation and Injury in the Medical Device Industry

Author Affiliations
  • 1National Clinician Scholars Program, Yale University School of Medicine, New Haven, Connecticut
  • 2Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 3Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut
  • 4Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut
JAMA. 2019;322(3):190-192. doi:10.1001/jama.2019.8147

The Bleeding Edge, a documentary directed by activist filmmakers Kirby Dick and Amy Ziering and released in 2018 on Netflix, uses patient testimony and expert commentary to educate the public about the medical device industry and the federal regulatory and approval standards that permit devices to enter the market. The film relies on recent instances of device failure to urge reform of a system designed to facilitate approval and diffusion of technologies ahead of clear evidence of safety and benefit.

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    2 Comments for this article
    FDA 510k - Failure to Regulate
    William Oldham, PhD | UC Berkeley
    The reviewers seem compelled to defend the FDA. Their 5th paragraph is remarkable; essentially excusing the failure to regulate because the FDA does so much good!

    The fact that it took a decade to get Essure marketing stopped with a similar story for the Depuy hip prosthesis surely compels a reconsideration of the weakness of 510k.  Moreover the FDA did not act; it was apparently an economic cost/benefit analysis that caused the manufacturers to withdraw the defective products from the market.

    Finally, the reviewers failed to notice Dr. Tower’s warning that cobalt poisoning from
    implants is not limited to the now-withdrawn Depuy prosthesis. Because of 510k, cobalt parts can be (and are) substituted in previously approved implants (hips, knees, shoulders...). Be sure to advise your friends needing such joint replacement of the dangers of cobalt. The FDA will not.
    What is An "Acceptable" Ratio of Those Who Benefit to Those Who Are Harmed?
    Timothy Spruill, EdD | Advent Health Family Medicine & Emergency Medicine Residency Programs in Orlando
    One thing I wish the documentary had addressed is the fundamental question of the ratio of those helped by a device vs. those who are harmed. What is the expectation of medical device manufacturers (or pharmaceutical companies)? Dr. Tower's reaction to the cobalt hip is not universal. What we don't know is how many patients implanted with cobalt devices suffer the effects he suffered. If a device helps 10 million users and harms 1000 should it be withdrawn from the market? Is it reasonable to assume that a given medication or device will be harmless to 100% of consumers who are encouraged to give it a try? A physician friend once told me that if a drug doesn't have side effects, neither does it have a main effect! My wife recently took a Tylenol 3 and had a severe allergic reaction that lead to her hospitalization. Many people, myself included find it to be an effective remedy for pain and/or an effective cough suppressant. Some are calling for it to be banned. Does the FDA have a rule of thumb when approving devices or medications as to what percentage of users suffering harm is acceptable due to the potential for good? If there is such a rule, I'd love to know what it is and how it was derived. I wish there was a website where consumers could report their personal experiences with drugs and devices similar to the Amazon product reviews. I don't trust the marketers.