Nov 26, 2018

Exporting dangerous medical devices

More than a dozen medical devices registered with the FDA for export to other countries — but not for use in the U.S. — have been identified as having "troubled track records" in an investigation by NBC News.

Between the lines: This raises questions about whether it is America's job to evaluate whether a medical device is safe for use in another country. But it also shows what can happen if health care companies are left alone to decide between consumer safety and profit.


  • These devices include heart valves that caused severe infections, shoulder implants that needed to be removed and stents that could cut into arteries that they were supposed to save.
  • There are about 4,600 devices registered with the FDA as "export-only," and American companies made more than $41 billion last year on exporting medical devices.
  • Some of the companies that make the devices identified by NBC failed to report serious adverse events.

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