The Cook Celect IVC filter is a medical device that is inserted into the inferior vena cava (a large vein that caries deoxygenated blood to the heart) to prevent pulmonary embolism in patients at risk for developing blood clots. The Celect was approved by the U.S. Food & Drug Administration (FDA) in 2008, and intended to be a replacement for Cook’s Gunther Tulip IVC filter, which was approved in 1992.
What’s the Problem?
The Celect was designed as a retrievable IVC filter, meaning that it should be removed once the blood clot risk has subsided. However, in many cases the devices are left implanted long after they are no longer needed, which increases the risk that the filter will puncture the vena cava or cause other life-threatening injuries.
Cook IVC Filter Medical Studies
In 2012, a study in the journal Cardiovascular Interventional Radiology reported that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall in under 3 months after being implanted. The study also reported that 40% of the filters were tilted and out of position.
Another study published by JAMA Internal Medicine in 2013 questioned the effectiveness of IVC filters. Researchers found that less than 10% of the devices were successfully removed, and 8% of patients had a pulmonary embolism after receiving a filter.
Then in June 2015, a study conducted by researchers at Northwestern University and the University of Colorado compared the retrievability of the Cook Celect and Rex Option IVC filters. The study’s authors looked at IVC filters implanted in patients over a 33-month period, with 99 Celect and 86 Option filters reviewed. The researchers concluded that the Cook Celect perforation rate was higher, with a 43% incidence of strut perforation.
In August 2010, FDA issued its first alert regarding problems with inferior vena cava filters. The agency had received over 900 adverse event reports, including:
- 328 where the IVC filter migrated from the implant site;
- 146 where components broke loose;
- 70 involving perforation of the inferior vena cava, and
- 56 reports that involved the filter fracturing.
Then in May 2014, FDA issued another warning about the need to remove IVC filters within 1 to 2 months of the blood clot risk passing. The recommendation came in response to adverse event reports concerning IVC filter perforation, migration, fracture, embolization and difficulty removing the devices.
IVC Filter Litigation
As of August 2015, at least 102 lawsuits have been filed in U.S. federal courts by plaintiffs who were allegedly injured by a Cook Celect or Gunther Tulip IVC filter. These cases have been centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana as part of a multidistrict litigation (MDL).
Do I Have a Cook Celect IVC Filter Class Action Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Cook Celect IVC Filter Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a lawsuit against the manufacturer and our lawyers can help.