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.