Defective Medical Devices

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Medical devices can save lives, but if it or a part of it because faulty, it could prevent the device from working properly. A defective medical device can make the condition worse, sometimes even fatal.

A medical device is typically implanted into the patient and if the device isn't functioning properly, this could lead to one or more follow-up surgeries, called "revision surgery", to remove the device.

The Food and Drug Administration (FDA) regulates the safety of medical products and devices. Those who manufacture and sell medical products and devices must ensure that their products do not harm the patients. Since 1976, the FDA has required that all new medical devices be proven safe and effective. Unfortunately, some medical devices are only as safe as the information known when the review takes place. In the past, products such as Sulzer hip and knee implants and Baxter dialysis filters have come under fire for injuring consumers. Some common medical devices include heart valves, pacemakers, prosthetic knee and hip devices, ventilators, x-ray machines, biopsy equipment, ultrasound, infusion pumps, and transvaginal mesh products.

In many cases, most medical devices are not tested for functionality. Even if the FDA grants approval of the marketing the device, healthcare professionals cannot assume that the FDA has determined that the product is safe for use. This means that just because the FDA approves a device doesn't mean it does not prevent a physician from prescribing or using that device for non-approved uses. This is because the physicians are not governed by the FDA approved uses. Only the manufacturer is governed by the FDA in terms of how it can market the product for use. The FDA requires "device user facilities" and manufacturers and distributors to promptly notify the FDA about device-related failures or events that may have caused a death, serious injury, or illness. These reports called Medical Device Reports (MDR's), are required to ensure that the most serious problems will be identified to the user.

If a medical device is considered defective, it is the manufacturer's responsibility to inform the FDA and the public about the defect and any potential risks involved. If the manufacturer does not properly inform the FDA in a timely manner, it can be considered an act of negligence, which can result in a liability being placed on the manufacturer. They will therefore be responsible for any illnesses, injuries or deaths that many occur due to the defective device.

Each year, the FDA receives approximately 100,000 reports through the MDR route and another 5,000 device reports through the voluntary MedWatch route.


Sometimes a Failure to Diagnose may lead to improper medication and unnecessary treatment that may result in serious injury, stress and suffering. Learn more about Failure to Diagnose lawsuits.