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How medical devices with known defects end up on the market

Numerous defective medical devices have been the subject of alerts, warnings and recalls in other countries — probably far more than most people realize.

Some medical devices that haven’t performed as well as expected include:

  • A pregnancy test that was recalled in both Australia and the United Kingdom because it was prone to giving false negatives, which put both pregnant women and their unborn children at risk
  • A dental drill that was the subject of “urgent warnings” in Germany and recalled in Australia because it could go too deep and cause patient’s permanent nerve damage and impair their speech
  • A catheter that was recalled in Australia because it frequently sprung leaks
  • An artificial hip with a metal ball that leaked toxic substances into patients’ bloodstreams and ground into their hip bones
  • An artificial knee joint that was recalled in Australia after patients began to fall when it malfunctioned
  • An implant designed to prevent pregnancy that was so problematic that officials in France, Italy and Singapore stepped in

Aside from being defective and the subject of official action in other countries, all of these devices have something else in common: They’ve never been recalled in the United States. Some of them remained available and in use long in the U.S. long after they were taken off the market in other countries. Some of them are still in use. Others were just quietly discontinued, without any notice to patients who might be impacted.

This happens because there’s no global system for tracking defective medical devices. The Food and Drug Administration (FDA) is notoriously slow to act compared to comparable agencies in other countries. Sometimes it eventually catches up and issues its own warning or recall. Other times, it doesn’t even have the power to do anything.

It’s an unfortunate reality that manufacturers of defective medical devices will put profits ahead of patients far too often. That’s why patients who have been injured by defective medical devices often have to resort to legal measures to seek justice.


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