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How does a medical device recall work?

Implantable medical devices can provide great benefits for a patient and, in many cases, can improve serious conditions, improve quality of life and allow an individual to live without pain. Occasionally, however, companies and doctors learn that these devices are ineffective or even dangerous, requiring a recall of the medical device.

If you received notice that your medical device is under recall, do you know what to expect? If you suffered injuries, additional medical problems or other complications as the result of problems with an implanted device, you may have grounds for a civil claim. Louisiana patients have the right to know of any risks or possible complications that may accompany the implantation of a medical device.

What you need to know about the recall process

When a manufacturer learns that there is a problem with a medical device, it may propose to correct the problem or remove the device altogether. When the problem violates U.S. Food and Drug Administration laws or poses a direct threat to a person's health, it is a recall. If you received notice that your device is under recall, it does not necessarily mean you will have to undergo surgery.

Here are the various ways that manufacturers can address potential and known issues through the recall process:

  • Inspecting the device for problems
  • Repairing the device
  • Adjusting settings
  • Removing the device altogether

Other important parts of the recall process include informing patients as soon as possible about problems or the product's ability to suddenly fail, as well as providing continued monitoring of the patients health status. Doctors must speak with their patients about the risks involved with repairs, potential surgery or simply leaving the device in place.

My medical device is under recall. Do I have a case?

A recall of a dangerous medical product does not guarantee that you will have a valid injury claim. However, there are certain factors that may indicate that you suffered unnecessarily. You may have a case if you were:

  • Not informed of the known risks involved with certain devices
  • Not notified of a recall in a timely manner
  • Misinformed about a product's likelihood to fail
  • Not given a full explanation of your rights and options under the recall

The manufacturers of medical products and the health care providers who prescribe them have a responsibility to fully inform and protect patient rights. Whether you suffered as the direct result of a defective device or from the additional medical intervention required due to risks and problems, you could benefit from a full explanation of your legal rights.

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