Complications involving IVC filters have been the subject of a growing number of lawsuits in recent months.

Now, a  study in the Journal of Vascular Interventional Radiology reveals the Cook Celect IVC filter poses a significant risk of puncturing a major blood vessel.

Researchers discovered that this particular IVC filter has a far higher rate of perforation compared to another type of IVC filter.

The study conducted by Northwestern University and the University of Colorado assessed the retrievability of the Cook Celect and Rex Option IVC filters. It was found that while retrieval rates were very similar between the two devices, the Cook Celect had a higher rate of perforation than the Rex Option model. The Cook device had a 43% rate of strut perforation, while the Rex Option had less than one percent.

The findings, which were published in the June 2015 issue of the Journal of Vascular and Interventional Radiology, offer even more clinical data about the risks associated with IVC filters.

What is an IVC Filter?

Retrievable IVC filters are small cage-like wire devices inserted in the inferior vena (a major vessel returning blood from the lower half of the body to the heart). IVC filters capture blood clots to prevent them from traveling to the lungs and causing a pulmonary embolism (a blood clot in the lungs), which can be deadly.

IVC filters are used on people at risk of a pulmonary embolism who cannot take anticoagulants or have previously taken blood thinners that did not help them.

IVC filters are designed to be implanted in the body for a limited amount of time and removed when the danger of pulmonary embolism has passed. However, concern has grown that too many IVC filters are not being removed in a timely manner and instead allowed to remain in the body and expose patients to unnecessary risk.

IVC Filter Complications

In 2010, the U.S. Food and Drug Administration issued its first safety alert regarding the increase of adverse reports related to IVC filters. Since then, the FDA and numerous studies have shown a widespread failure on the part of doctors to remove these devices once they are deemed no longer necessary.

IVC filter complications may include:

• Pulmonary embolism
• Infection or a hematoma at the access puncture site
• Damage to the vena cava
• Damage to the tissue and organs surrounding the vena cava
• Hemorrhage
• Filter movement to the heart or lungs
• Fracture of the filter in the vena cava
• Filter not positioned correctly in the vena cava
• Death

IVC Filter Litigation

Multidistrict litigation claims against Cook Medical allege its IVC filter caused harm to patients, including device migration, fracture, tilting, and perforation. Multidistrict litigation refers to a special legal procedure designed to speed up the process of trying complex cases by grouping them together under one judge.

As of October there were 133 IVC Filter Lawsuits against Cook Medical in the IVC Filter MDL, In Re: Cook Medical, Inc., IVC Filters Marketing, Sales, Practices and Products Liability Litigation, MDL No. 2570.