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DEFECTIVE MEDICAL DEVICES

Defective Medical Devices
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When Medical Devices are Found Faulty, Serious,
Possibly Critical, Injury can Result

When Medical Devices are Found Faulty, Serious, Possibly Critical, Injury can Result

When Medical Devices are Found Faulty, Serious, Possibly Critical, Injury can Result

Medical devices can save lives, but not if a faulty design prevents them from working properly or if a part of the product were to become contaminated during the manufacturing process. A defective medical device can make the condition it was designed to treat worse, sometimes a great deal worse.

Often, medical devices require an operation to be transplanted inside the patient; if a device is found not to work properly, or to have unintended unhealthy side effects, this could necessitate one or more follow-up surgeries, called “revision surgery,” to remove or otherwise address the implanted problem.

Medical devices are extensively tested before they are prepared for the U.S. Food & Drug Administration (FDA), which approves all medical devices before they can be sold on the U.S. market – although the devices’ manufacturers remain ultimately responsible for ensuring the product’s safety.

Every year, millions of people are implanted with medical devices, the list of which includes hip replacements and transvaginal mesh products; they allow this under the belief that these products will enable them to live a healthier, better-quality life. But if these products were to be defective in some manner, they stand to make a person’s health problems worse, leaving them at risk for a variety of debilitating injuries. This risk is especially high for people requiring long-term care.

When a medical device is discovered to be defective, it’s the manufacturer’s responsibility to inform the FDA and the public about the flaw and any potential risks that may arise. If the manufacturer does not properly inform the public and the FDA in a timely manner about the defect, it can be considered an act of negligence, which can make the company liable for injuries, illnesses or deaths that may occur due to the faulty device.

Many problems with defective medical devices only become apparent with the passage of time. If the device is implanted, this means a person can quite possible suffer a variety of symptoms quite extensively in the time it takes for the revision surgery to occur. Even then, revision surgery does not always solve the problem, which sometimes requires repeated surgery.

If you, or your loved one, has been harmed by a defective medical device, you may have valuable legal rights. Please feel free to contact us by completing the form at the right or call us at 1-800-LAW-FIRM (1-800-968-7529).

If the defective medical device you are looking for is not listed in the links below, please visit our Defective Medical Devices archives page for additional articles.

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Defective Medical Devices NewsRSS Feed

Duodenoscopes Linked to Superbug Outbreak were Sold without FDA Approval

Mar 6, 2015
The specialized endoscopes implicated in the recent UCLA superbug outbreak were sold without approval from the U.S. Food and Drug Administration...

Duodenoscopes Linked to More Superbug Infections, FDA Updates Safety Communication

Mar 6, 2015
Duodenoscopes have been linked to more cases of drug-resistant bacterial infections. The New York Times reports that four patients at Cedars-Sinai...

HeartWare Recalls Clinical Trial Ventricular Assist System Controllers

Feb 27, 2015
Older versions of HeartWare's Ventricular Assist System Controllers are being recalled in the United States. The recall, which is an extension of an...

FDA Investigates Duodenoscope Disinfection Methods After Reports of Infections

Feb 27, 2015
The Food and Drug Administration (FDA) has asked duodenoscope manufacturers to provide evidence that their recommended disinfection methods work,...

AliverCor's Heart Monitor App is Recalled

Feb 26, 2015
AliverCor's AliveCor has recalled their AliveECG app Version 2.1.2 used with AliveCor Heart Monitor. According to HIT Consultant, the recall is due...

General Electric Recalls MRI Units for Safety Concerns

Feb 25, 2015
GE Healthcare initiated a "field corrective action" earlier this month on nearly 13,000 magnetic resonance imaging (MRI) units worldwide after...

FDA Aware that Duodenoscopes Can Spread Fatal 'Superbug' But Did Not Enforce Fix

Feb 24, 2015
The U.S. Food and Drug Administration (FDA) has been aware that duodenoscopes can spread life-threatening infections since at least 2009 but did not...

Life-threatening Issue Prompts Recall of General Electric MRI Systems

Feb 23, 2015
The Food and Drug Administration (FDA) has announced a Class I recall for more than 12,000 General Electric magnetic resonance imaging (MRI) systems....

Endoscopes May Have Exposed 179 Patients to 'Superbug', LA Hospital Warns

Feb 23, 2015
The UCLA Ronald Reagan Medical Center has warned 179 patients that they may have been exposed to a drug-resistant bacteria during endoscopy...

FDA Says Duodenoscope Design can Impede Cleaning, Potentially Spread Bacterial Infections

Feb 20, 2015
The U.S. Food and Drug Administration (FDA) has issued a new safety alert concerning endoscopic retrograde cholangiopancreatography (ERCP)...

Class I Recall Issued for Covidien Trellis 6 & Trellis 8 Peripheral Infusion Systems

Feb 12, 2015
Covidien has recalled its Trellis 6 and Trellis 8 Peripheral Infusion systems due to a labeling issue, according to a recall notice posted on the...

Unapproved Knee Replacement Device Used in Surgery

Feb 11, 2015
When undergoing surgery, most patients would assume that the tools being used have been proved to be safe and effective. Unfortunately, this is not...
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