This Weeks' Topic
Medical Recall

What happens when a surgically implanted medical device is recalled by the manufacturer? A product recall can be alarming, since it means that we might have an unsafe device or food in our home. But imagine the feeling of panic when you hear that a medical device that has been surgically implanted into your body has been recalled.

 

Let’s start with an  example?

  • Sometimes your doctor can do a great job, but the medical product they use if defective.
  • A few years ago, a certain type of Sulzer hip replacements  products wouldn't bond with the bone and was defective, and in many cases had to be replaced which required additional surgery.

Is the manufacturer liable for health problems caused by faulty devices?

In the hip replacement cases, after complaints had been filed with the FDA, a recall was started by the manufacturer, and the manufacturer is liable for damages.

Does the FDA have different levels or classes of recall of medical products ?

  • Class 1 recalls signify a potential for significant risk to your health.
  • Class 3 recalls reflect that the medical product is defective, but the health risk is not great. 

 Can you give us an example of a current medical recall?
 

  • A recent recall deals with the mesh used in some hernia operations.
  • When the mesh fails, the tissues rupture and damage can occur in the intestines or other abdominals organs.

Aaron, what is the bottom line and how can people find out about medical product recalls?

  • If you are having unusual complications, talk to your doctor.

 

 

 

Disclaimer
This information is general and may or may not apply to your situation. The information contained on this web site is not to be considered as legal advice. Since no two cases are identical, we recommend that you contact an attorney in your jurisdiction to discuss the specific facts of your case. Furthermore, since statutes and case law change so frequently and due to information provided by other sources, we make no warranty or guarantee concerning the accuracy of the content of this or any other web sites to which we link.


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