Inferior vena cava (IVC) filter use as a blood clot treatment is under scrutiny as more than 900 severe adverse event reports have been reported to the U.S. Food and Drug Administration to date.

According to the FDA, the small cage-like device that is placed into the main vein to trap blood clots until they dissolve can be an effective treatment for short-term use but should be removed as soon as the risk of pulmonary embolism or heart attacks has subsided. The federal agency warns that serious IVC filter complications may occur due to long-term placement.

What is an IVC Filter?

Some patients at high risk for blood clots are unable to take an anticoagulant medication. An IVC filter may be a good alternative treatment for those patients, as it can help eliminate the life-threatening risk of blood clots traveling to the heart or lungs.

The U.S. Food and Drug Administration has approved IVC filter implantation for treating pulmonary thromboembolism when blood thinners shouldn’t be used, when anticoagulant therapy fails to work in thromboembolic diseases, for cases of recurring pulmonary embolism when anticoagulant use has failed, and for emergency treatment following massive pulmonary embolism when expected benefits of traditional therapy are reduced

However, after receiving hundreds of adverse event reports the FDA has issued a warning about IVC complications that may occur with long-term use.

IVC Filter Risks

Some of the most commonly reported IVC filter complications include:

• IVC filter fracture
• Filter migration
• Caval penetration
• IVC thrombosis
• Access site thrombosis
• Deep vein thrombosis (DVT)

According to a recent FDA recommendation, the agency believes that most of the complications occurred because the device implant was left in the system for too long. The agency now encourages physicians to remove IVC filters after 29 to 54 days in order to avoid serious health risks.

IVC Filter Studies

Several IVC filter studies suggest there may be a serious design defect with the medical device. According to one study published in Cardiovascular Interventional Radiology, researchers discovered that 100 percent of Cook Celect and Gunther Tulip IVC filters pierced through the vein wall within 71 days of implantation.

Another IVC filter study published in the Journal of the American Medical Association discovered that eight percent of IVC patients experienced a pulmonary embolism regardless of the medical device.

IVC Filter Lawsuits

In general, plaintiffs who have filed an IVC filter lawsuit claim similar injuries caused by the device. Some IVC filter lawsuits allege the device broke into pieces, which then traveled to the heart or lungs. Other plaintiffs report that the filter perforated the vena cana and then traveled to nearby organs including the aorta, bowels and liver.

In recent litigation, plaintiffs across the U.S. have requested that the IVC filter lawsuits be transferred into a multidistrict litigation centralized in the U.S. District Court for the Southern District of Indiana.

There are 27 individual IVC filter lawsuits currently pending in 11 different districts.