Defective Medical Device Recall
I’m Ed Smith, a Folsom personal injury attorney. Sometimes, a defective medical device recall happens when the device is found to be defective or dangerous. Medical devices can include a wide variety of devices such as prosthetics, surgical instruments or implants. When a patient is the recipient of a faulty or dangerous medical device, it can result in a poorer prognosis, repeated surgeries to correct the problem or even death.
What Government Agency Regulates Medical Devices?
The U.S. Food and Drug Administration is in charge of both approving medical devices and handling recalls. Most of the time, an official recall is not necessary, since the manufacturer frequently recalls a defective or dangerous product voluntarily. Some criticism of FDA has arisen since the approval of premarket notification. This is a procedure by which a company can claim that a new product is similar enough to one already on the market that it does not require extensive testing. Some of the products that have been recalled were approved using this fast-track process.
Are Patients With Defective Devices Notified?
In most instances, patients who have been given a defective device are notified by their physician or surgeon who implanted the device. In addition, FDA publishes press releases that a potential risk is possible with the affected device. The FDA Enforcement Report is published weekly and is available for viewing by the public.
Classes of Defective Device Recalls
Defective or dangerous medical devices are separated into three different products liability categories.
- Class I is the most serious, where the device may cause health problems that are serious or result in the death of the user.
- Class II recalls can create a slight risk, which is either temporary or reversible.
- Class III includes products unlikely to cause any injury.
Recalled Medical Devices
As a personal injury attorney in Folsom, some of the devices we have experienced to be dangerous and are under recall are as follows:
- DePuy Hip Replacement: Two different hip replacement systems were recalled by the manufacturer.
- IVC filters for blood clots have caused fatalities.
- Hernia patch manufactured by Kugel
- Ethicon physiomesh
- Transvaginal mesh
When A Medical Device Has Been Recalled
Being faced with another hip replacement or surgery caused by a defective product can be devastating physically, emotionally and financially. Knowing what to do if your implanted medical device has been recalled is important. An experienced injury attorney can help by explaining your rights and by filing a claim to recover fair compensation for your injury. This is especially important when you face further surgery and traumatic injury rehabilitation, which results in more medical bills and lost wages. For information on how to recover compensation for these types of damages, contact an experienced personal injury attorney in Folsom.
Related article by Folsom Personal Injury Lawyer ~ Ed Smith
Folsom Personal Injury Attorney
I’m Ed Smith, a Folsom personal injury attorney. If you or a family member has been a victim of a faulty or dangerous medical device, I am here to offer you my friendly advice free of charge. Call me at (916) 921-6400 or at (800) 404-5400. You can also contact me at our online contact page on my website, AutoAccident.com.
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I am honored to have served the residents of Folsom and Sacramento County for 35 years. Other areas of my practice include truck accidents, motorcycle accidents, wrongful death, dog bite injuries and catastrophic injuries such as brain injuries.
Photo Attribution: https://pixabay.com/en/progress-clinic-medical-care-for-1807543/
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