Unsafe Medical Devices

Medical devices have revolutionized health care, but many people have suffered injury — and even death — as result of unsafe medical devices. A medical device is any device used by a doctor or health care provider to treat a disease, injury or illness. Medical devices include implants (such as artificial hips, knees or shoulders), defibrillators (electronic devices that deliver shocks to the heart to help maintain normal heart function) and stents (tubes inserted into the arteries to help prevent blockages).

Each year, The U.S. Food and Drug Administration (“FDA”) receives several hundred thousand reports of malfunctions, serious injuries and deaths suspected of being associated with defective medical devices.  These reports — known as “Adverse Event Reports” — sometimes lead to recalls of dangerous or defective medical devices.

If a medical device manufacturer discovers a defect in one of its products, the manufacturer is required to notify the FDA and the public.  This duty begins with the development of the medical device, and it continues for as long as the medical device remains on the market.   If a medical device manufacturer fails to properly to notify the FDA and the public of a defect with one of its products, it can held responsible for illnesses, injuries and deaths caused by the faulty medical device.

For more information, see our Unsafe Medical Device FAQ.

Often, medical devices are implanted in the body.  If a defective medical device is discovered after the device has been implanted, the device sometimes must be removed from the body, or “explanted.”  This procedure is called a “revision surgery” and it subjects the patient to additional pain, risk of infection and prolonged rehabilitation.