Although medical devices must undergo extensive testing to determine whether or not they are safe, sometimes the dangers of a medical device do not get revealed until after numerous patients have received them. When a device is determined to be dangerous or defective, doctors will usually carry out one of the following two actions:
- Correction: This involves fixing the medical device’s problem but not actually replacing it.
- Removal: This involves taking the medical device off the market and removing it from wherever it is being used.
The Food and Drug Administration (FDA) refers to both “correction” and “removal” of a problematic medical device as a “recall.” The FDA orders a recall when it determines that a medical device could represent a health risk, when it is defective or when it is both a health risk and defective.
It should be noted that just because a particular device has been recalled does not mean that it cannot be used anymore. Sometimes, all that is required is an adjustment, a fix or having the device checked to ensure it’s safe. Also, not all recalled medical device implants must be removed (or explanted) from the patient. Usually, doctors will discuss the potential risks associated with removal and replacement of a defective implant, so that they can make a decision about whether to fix, remove or take some kind of action relating to the problematic implant.
If you have a defective medical device, if you have a defective implant or if you were seriously harmed by one of these. you may want to speak to a personal injury lawyer who represents patients hurt by defective medical devices. A lawyer can help you review your legal rights and options and advise you on what steps — if any — you can take to pursue financial compensation.
Source: U.S. Food and Drug Administration, “What is a Medical Device Recall?,” accessed Aug. 24, 2017