New Study Indicates Risks with Cook Celect IVC Filters

IVC filter problems have been the subject of a growing number of lawsuits in recent months. Now, another study has identified potential complications associated with the Cook Celect IVC filter. Researchers discovered that this particular IVC filter had a high rate of strut perforations in comparison to a similar device by a different manufacturer.

Researchers from Northwestern University and the University of Colorado made their discovery while assessing the retrievability of the Cook Celect and Rex Option IVC filters. They found that while retrieval rates were very similar between the two devices, the Cook Celect had a higher rate of perforations than the Rex Option model. In fact, the Cook device had a 43-percent rate of strut perforation, while the Rex Option had less than one percent.

More data on IVC filter problems and risks

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. These devices have been used since 1979, but have become more common in recent years. Today, thousands of these filters are implanted every year to prevent pulmonary embolism (PE) in patients diagnosed with deep vein thrombosis or DVT.

The filters are typically recommended for patients who are unable to take blood thinning medications after blood clots have been detected. The devices are placed in the inferior vena cava, the largest vein in the body, to prevent blood clots that form in the legs and pelvic area from breaking loose and moving to the lungs. Blood clots in the lungs result in PE, which is a life-threatening condition requiring emergency medical treatment.

Unfortunately, increased use of the devices have also resulted in increased concern over potential complications. Reports of perforation, migration and filter fractures have posed serious adverse events for some patients. The majority of complications have involved migration of the device, where the filter moves to other areas of the body.

FDA issues safety communication

In May 2014, the FDA issued a safety communication, stressing the importance of removing IVC filters promptly after the threat of PE has passed. The agency noted that risks of complications could be related to how long the filter was implanted. The safety communication also noted physicians should be covering both the risks and benefits of the devices with patients carefully, before making the decision to implant them.

Many patients who have suffered severe health complications from the devices have filed IVC filter lawsuits against the manufacturers, claiming the companies did not provide proper warning of the risks. Lawsuits involving IVC devices manufactured by Cook Medical have been coordinated into multidistrict litigation in U.S. District Court for the Southern District of Indiana. Multidistrict litigation was established to streamline early trial proceedings, prevent duplicate discovery and conflicting rulings, and serve the convenience of all parties involved. There are currently more than 100 cases pending in that litigation.

The U.S. Judicial Panel for Multidistrict Litigation is also considering a request to coordinate lawsuits involving IVC filters manufactured by Bard, as more cases continue to be filed against that manufacturer.

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