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When a medical device threatens your health

When your health care provider recommends that you have a medical device surgically implanted, your concerns may be more focused on doctor errors than product liability. However, heart monitors, hip replacements and similar products are subject to design flaws, manufacturing errors and mislabeling, just as any other consumer good is. Our team at Bendall & Mednick have represented many people who suffered injuries or lost family members due to a faulty medical device.

The U.S. Food and Drug Administration explains that a company should recall a medical device if there is evidence that it may cause you to develop a health problem, when it is defective, or both. Although the manufacturer of the medical device or its distributor may initiate a recall voluntarily, if the product is linked to injuries or deaths, the FDA has the authority to compel the company to issue the recall.

Once a device is implanted in your body, removing it could pose a serious risk, too. Even though the product violates some FDA regulation, your doctor may determine that you are more likely to have health problems associated with the removal than with the threat the device itself may cause. It is also possible that the recall could be due to a flaw that can be corrected without requiring your doctor to remove and replace the device.

The company typically identifies who has received the devices and notifies the health care providers who implanted them with instructions and potential problems for patients. More information about product recalls and safety is available on our web page.

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