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To the Editor— The “Guidant Affair”: Little has changed since Joshua’s death

      In regard to the “Guidant Affair”: 15 years later,
      • Maron B.J.
      • Estes N.A.
      The “Guidant Affair”: 15 years later.
      I disagree with the authors’ conclusion that now there is “greater transparency (and more effective communication) with independent advisory boards and effective product performance reports (p. 488).”
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      References

        • Maron B.J.
        • Estes N.A.
        The “Guidant Affair”: 15 years later.
        Heart Rhythm. 2021; 18: 487-488
      1. Hauser RG, Casey SA, Gitter CB, et al. Reliability and longevity of implantable defibrillators [published online ahead of print January 2, 2021]. J Interv Cardiol. https://doi.org/10.1007/s10840-020-00920-w.

        • Resnic F.S.
        • Majithia A.
        • Marinac-Dabic D.
        • et al.
        Registry-based prospective, active surveillance of medical device safety.
        N Engl J Med. 2017; 376: 526-535

      Linked Article

      • The “Guidant Affair”: 15 years later
        Heart RhythmVol. 18Issue 3
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          Fifteen years ago, the avoidable sudden death of a young man, Joshua Oukrop, (with nonobstructive hypertrophic cardiomyopathy) due to failure of his defective implantable cardioverter-defibrillator (ICD) led to revelations known as the “Guidant Affair.”1 Disclosure of this event triggered worldwide recall of >200,000 potentially flawed ICDs and pacemakers, penalties for Medicare fraud, Pulitzer nomination for New York Times, dissolution of Guidant as a flourishing company for undermining public trust, as well as a movement for meaningful reform in the device industry (Online Supplemental Table 1).
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