Burke et al,1 in this issue of the Journal, estimated that the cost to Medicare related to the Medtronic Sprint Fidelis lead failures is in the range of dollar167,000,000 to dollar806,000,000. Although critics may dispute the methods used in these calculations, the assumptions are reasonable, and whatever the true cost may be, it is substantial. In a larger context, the cost to Medicare related to treatment of patients with medical devices that fail or cause less catastrophic problems is a huge number. A recent analysis of medical device recalls identified 113 recalls from 2005 through 2009 that could cause serious health problems or death, and cardiovascular devices comprised the largest recall category.2 In 2005, approximately 24,000 patients underwent procedures related to other problems with Medtronic or Guidant devices.3 Although the companies provided replacements and compensated patients for up to dollar2,500 in out-of-pocket expenses, the remaining cost to Medicare and private insurers was not shared by industry. By one estimate, the cost to Medicare related to those replacement procedures was about dollar120 million.
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