After a recent study, researchers have determined that the long-term risks of using an IVC filter to help patients prevent blood clots outweighs any potential benefits.

In April, a team of French researchers analyzed patients who had an inferior vena cava (IVC) filter implanted as a way to avoid pulmonary embolism.

The researchers compared those patients to ones who were prescribed an anticoagulant to treat their medical condition.

The study found that patients who were implanted with an IVC doubled their risk of having blood clots travel to their lungs (pulmonary embolism).

Some medical experts have challenged the group of researchers, stating that long-term benefits of IVC filters appear after a year of implantation. However, the researchers argued that any long-term benefits of the medical device are outweighed by the fact that IVC patients have a greater risk of deep venous thrombosis as well as pulmonary embolism.

Based on their study findings, researchers recommend that IVC filters not be used by any patients who could be prescribed a blood thinner to treat their medical condition. They state that the long-term benefits of anticoagulants resulted in a more favorable option of blood clot treatment.

IVC Filter Studies

An IVC filter is a small cage-like device that is inserted into the main vein in order to trap blood clots until they dissolve. The U.S. Food and Drug Administration (FDA) has approved it for use in treating pulmonary thromboembolism when blood thinners can’t or shouldn’t be used, and in emergency treatment following massive pulmonary embolism when expected benefits of traditional therapy are reduced

The implant has been the subject of many studies after patients reported serious IVC complications including filter migration and filter fracture that caused small fragments to travel into the heart and lungs.

In a 2012 study published in Cardiovascular Interventional Radiology, researchers found that 40 percent of IVC filters moved out of position, while almost all of Gunter Tulip and Cook Celect filters perforated the venal cava wall within 71 days of implantation.

In 2013, a study published in JAMA Internal Medicine found that eight percent of IVC patients suffered from pulmonary embolism regardless of the medical device, while less than 10 percent of the analyzed filters were removed successfully.

After multiple studies and hundreds of adverse event reports, the U.S. Food and Drug Administration announced that physicians should remove IVC filters as soon as the risk of pulmonary embolism has subsided. The federal agency suggests the time frame for removal should be within one to two months, stating that serious IVC filter complications may occur with long-term placement.

IVC Filter Risks

While the FDA has approved IVC filter use for specific circumstances, the agency warns that in order to avoid serious complications, short term use of the IVC filter is key.

Commonly reported IVC filter complications include:

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

The FDA announced that out of the 921 IVC filter adverse event reports they have received, 328 involved device migration, 146 involved detached device components, 70 reported IVC perforation, and 56 claimed filter fractures.

IVC Filter Lawsuits

A growing number of plaintiffs continue to file IVC filter lawsuits throughout the nation. In 2014, all Cook Gunther Tulip and Cook Celect lawsuits were consolidated into a mulitdistrict litigation centralized in the Southern District of Indiana.

All Bard IVC filter lawsuits have also been consolidated into an MDL, centralizing the complaints within the District of Arizona.

In general, IVC filter lawsuits allege the medical device caused some sort of internal injury. Some plaintiffs claim the IVC filter perforated the vena cava and traveled to nearby organs including the bowels, liver and aorta, while other plaintiffs allege the device broke into fragments which then traveled to the heart or lungs.