Melissa LaFreniere  |  July 8, 2015

Category: Legal News

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GranuFlo Cardiac Arrest LawsuitAfter receiving more than 900 severe adverse event reports regarding IVC filters, the U.S. Food and Drug Administration recommends physicians remove the medical device as soon as the risk of pulmonary embolism has subsided. According to the FDA, the inferior vena cava (IVC) filter, which is placed into a major vein in order to capture blood clots before they travel to the heart or lungs, should be implanted for short-term use only due to the risks associated with long-term placement.

The agency states that of 921 IVC filter adverse event reports, 328 involved device migration, 146 involved detached device components, 70 reported IVC perforation, and 56 claimed filter fractures. The FDA believes that some of these events may have occurred because the IVC filters were not retrieved in a timely manner and were left in the body for long periods of time.

Long-Term IVC Filter Complications

An IVC filter is a small, cage-like device that is placed into the vena cava in order to trap blood clots and keep them there until the body can dissolve them. Blood clots are a serious health risk. If left untreated, they can travel to the heart or lungs and cause life-threatening conditions including heart attacks or pulmonary embolism. Sometimes anticoagulant medication can be used to treat blood clots, but in some cases an IVC filter is the best option.

The FDA has approved IVC filter implantation for the following reasons:

  • Emergency treatment following massive pulmonary embolism when expected benefits of traditional therapy are reduced
  • Treating pulmonary thromboembolism when blood thinners shouldn’t be used
  • Thromboembolic diseases when anticoagulant therapy fails to work
  • Recurring pulmonary embolism when anticoagulant use has failed

Despite being an effective alternative for patients who cannot or should not use an anticoagulant for blood clotting treatment, the FDA reports IVC filter complications can be serious. Based on hundreds of adverse event reports, the FDA recommends that physicians remove IVC filters from patients between 29 and 54 days after implantation in order to reduce the risk of the long-term complications.

Some of the known long-term IVC filter risks include caval penetration, deep vein thrombosis (DVT), filter migration, IVC perforation, access site thrombosis, IVC thrombosis, filter fracture, and filter embolization.

Recent IVC Filter Studies

In a recent study published in the Journal of the American Medical Association, researchers discovered that eight percent of patients implanted with the IVC filter experienced pulmonary embolism. Another study published in the journal Cardiovascular Interventional Radiology found that 100 percent of Cook Medical’s IVC filters perforated through the vena cava wall within 71 days of implantation.

These and other IVC filter studies have lead to numerous lawsuits by plaintiffs who have experienced long-term side effects from the medical device.

IVC Filter Lawsuits

In general, plaintiffs filing IVC filter lawsuits allege the devices caused serious injuries by perforating the vein and traveling to nearby organs including the aorta, bowels, and liver. Other IVC filter plaintiffs claim that the filter broke into pieces that traveled to the heart or lungs.

In general, IVC filter lawsuits are filed individually by each plaintiff and are not class actions.

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Join a Free IVC Filter Class Action Lawsuit Investigation

If you or a loved one were injured by IVC filter complications, you may have a legal claim. See if you qualify to pursue compensation and join a free IVC filter class action lawsuit investigation by submitting your information for a free case evaluation.

An attorney will contact you if you qualify to discuss the details of your potential case.

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