Drug and Defective Medical Devices Law

IVC Filter

Key Takeaways:

  • Inferior vena cava (IVC) filters are implanted medical devices that are supposed to protect against pulmonary embolism. 
  • When IVC filters are not removed, there is a risk of device migration, filter fracture, and organ perforation. 
  • Many IVC filter patients have filed claims against the device manufacturers for damages.

Inferior vena cava (IVC) filters can help patients reduce the risk of blood clots and pulmonary embolism. However, a defective IVC filter can cause more harm than good. When IVC filters don’t work as intended, they can migrate to other parts of the body. In another part of the body, the IVC filter can cause organ damage, perforation, and infections.

Many IVC filter patients are not aware they received a defective medical device. If you or a loved one was injured by a defective medical product, contact an IVC filter attorney to understand your options.

What Is an IVC Filter?

The inferior vena cava (IVC) filter was first invented in 1967. It is a small wire device implanted in the inferior vena cava, a large vein. The IVC filter surgery goes through a small incision in the neck or groin to move the IVC filter to the appropriate location.

Deep vein thrombosis (DVT) is a serious medical condition where blood clots develop in the body. This can cause blockage in the veins, leading to swelling, discomfort, and valve damage. Long periods of sitting or lying down can increase the risk of DVT clotting. The IVC filter is supposed to stop DVT blood clots from reaching the lungs.

Patients who may need an IVC filter include those with limited mobility, recent surgery, or long periods of travel. An IVC filter may be the best option for patients who cannot use blood thinners, but they can also be used in combination.

What Happens With Defective IVC Filters?

The IVC filters were approved for permanent implantation. However, the longer they remain in place, the more the risk of dangers from defective devices increases. There were several problems with defective IVC filters, including:

  • Filter fracture
  • Device migration
  • Organ perforation

If an IVC filter comes loose or fractures, it can travel to other parts of the body. The device can cause organ penetration or become implanted in the veins, making it difficult or impossible to remove.

IVC Filter Warnings and Recall Notices

In 2010, the U.S. Food and Drug Administration (FDA) issued a safety communication for doctors with IVC filter patients. The FDA reported receiving reports of adverse events, including filter migration, embolization, and perforation of the IVC. The FDA recommended doctors monitor patients and consider removing the filter when appropriate.

There have been many retrievable IVC filter manufacturers. IVC filter medical device manufacturers include:

  • C.R. Bard Recovery
  • Bard G2 Express
  • Cook Celect
  • Cook Medical Günther Tulip
  • Cordis

Since 2005, the FDA has received more than 1,000 adverse event reports involving the use of IVC filters. Device migration is the most common report. These adverse events caused side effects, injuries, and additional surgeries.

In 2014, the FDA updated its safety communication, recommending doctors consider removing the filter as soon as the need is lifted.

In 2015, the FDA issued a warning letter to C.R. Bard for violations, including: “Failure to submit a report after receiving information suggesting a device has malfunctioned, likely to cause or contribute to serious injury or death.”

There have been several Class 1 and Class 2 device recalls for IVC filter systems.

Can You File a Defective Medical Device Lawsuit?

Some studies found that IVC filters were used more often than necessary. Many patients received implants that were never recovered. Many IVC filter patients were unaware of the risks or the options for retrieval. After learning of the dangerous devices, many patients filed IVC filter lawsuits.

A product liability lawsuit allows consumers to recover compensation for dangerous devices. Medical device defect cases generally involve one of the following types of defects:

  • Design defect
  • Manufacturing defect
  • Improper warning defect

When a patient is injured by a defective device, the manufacturer is liable for damages. Damages include medical bills, lost income, and wrongful death.

How Can an IVC Medical Device Defect Attorney Help?

There have been several IVC filter claims by patients and family members. Many of these patients joined class action lawsuits to hold the medical device manufacturers accountable. One company settled most of the claims for the Bard IVC filter in an Arizona federal lawsuit. However, there are still open cases in Indiana as of 2023.

A medical device defect attorney can help you understand your legal options. You may be able to file a personal injury, product defect, or medical malpractice claim. Your attorney can review your case and help you file a claim.

A defective medical device lawsuit can help you recover money for your injuries, including:

  • Medical bills
  • Lost income
  • Loss of support
  • Pain and suffering
  • Future medical care

To get a case evaluation for your IVC filter claim, talk to an IVC filter attorney for legal advice.

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