Our lawyers are investigating injuries caused by the Cook Celect vena cava filter. When retrievable IVC filters are not removed, patients can suffer life-threatening complications like fracture, migration, embolization, and unsuccessful retrieval.
Need a Texas Cook Celect Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Woman With Broken IVC Filter in Heart Files Lawsuit
September 1, 2016 — A lawsuit (PDF) has been filed by a woman from California who was seriously injured by a Cook Celect® IVC Filter that broke and became permanently embedded in her heart. Click here to read more.
Study Links Cook Celect IVC Filter to 43% Perforation Rate
August 10, 2015 — A new study has linked Cook Medical’s Celect IVC filter with a 43% rate of vena cava perforation, compared to a 0% rate for the Option filter made by Rex Medical.
What is the Cook Celect?
Cook Medical introduced the Cook Celect vena cava filter in 2008. It was approved with an FDA 510(k) clearance, which allows manufacturers to avoid conducting safety studies so long as a new device is “substantially equivalent” to an existing device. The Cook Celect is an improved version of the Günther Tulip, which has been on the market since 1992.
What is the problem?
The Cook Celect is a retrievable filter that is implanted in the inferior vena cava (IVC) to catch blood clots before they travel to the lungs and cause a pulmonary embolism. Retrievable IVC filters are only intended for short-term protection. After 3-4 months, the risk of complications increases significantly. If the filter fractures or migrates in the body, it may become difficult or impossible to remove. IVC filters may also perforate internal organs or cause deadly heart problems.
Studies of Cook Celect Retrieval Problems
In 2009, a small study of 115 people with a Cook Celect IVC filter. In several cases, doctors were unable to remove the filter because the hooks became embedded in cells lining the vena cava. Researchers warned, “Failed retrieval secondary to hook endothelialisation continues to be an issue with this filter.”
Studies Find High Risk of Perforation
In June 2015, a study linked Cook Medical’s Celect IVC filter with a 43% rate of vena cava perforation, compared to a 0% rate for the Option filter made by Rex Medical.
In April 2012, a study published in the journal Cardiovascular and Interventional Radiology found higher rates of vena caval perforation the longer the Cook Celect was implanted in a patient.
After reviewing 50 patients who were implanted with a Cook Celect or Günther Tulip filter between 2007-2009, researchers found:
- Perforation of at least one filter component through the IVC was observed in 43 of 50 (86%) filters on CT scans
- All filters imaged after 71 days showed some degree of vena caval perforation
- Filter tilt was seen in 20 of 50 (40%) of filters.
Another study published in 2009 involved 115 patients implanted with the Celect filter. Retrieval rates were good, but in some cases doctors struggled to remove the filter because it had become embedded in the vena caval wall.
In August 2010, the FDA published a Safety Communication for retrievable IVC filters. Since 2005, they had received 921 reports of IVC filter complications. These complications included migration (328 reports), embolizations and device component detachment (146 reports), perforation of the vena cava (70 reports), and filter fracture (56 reports). The FDA warned that some events might have been caused by retrievable filters remaining in a patient after the risk of pulmonary embolism subsided.
Need a Cook Celect Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Cook Celect IVC filter lawyers for a free lawsuit review.