The Schmidt Firm, PLLC is investigating serious injuries caused by the Cook Celect vena cava filter. This retrievable IVC filter can potentially fracture, migrate, perforate internal organs, and cause other life-threatening complications.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently evaluating IVC filter cases in all 50 states, regardless of whether you have been injured or not. If you or somebody you know was implanted with an IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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. Click here to read more.
What is the Cook Celect?
Cook Medical manufactures the Celect Vena Cava Filter. It was approved in 2008 under the FDA 510(k) approval process. This allows manufacturers of new devices to avoid conducting new safety studies so long as the device is similar to another device on the market. Cook introduced the Celect as an improved version of the Günther Tulip IVC filter, which was approved in the 1990s.
Cook Celect Retrieval Problems
IVC filters were originally intended to be a last-resort option for people at risk of pulmonary embolism who could not take blood-thinning drugs. However, in the last decade, the popularity of IVC filters has skyrocketed. This is largely due to the creation of retrievable filters, including the Cook Celect, which are supposed to be removed after the patient is no longer at risk of a pulmonary embolism.
Unfortunately, it may not always be possible to remove a filter. In 2009, researchers published a study of 115 people implanted with the Cook Celect. In some cases, it was impossible to remove the filter because the hooks became embedded in the epithelial lining of the vena cava. Researchers warned, “Failed retrieval secondary to hook endothelialisation continues to be an issue with this filter.”
Studies of Cook Celect IVC Filter Complications
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 2012, a study published in Cardiovascular and Interventional Radiology studied 50 patients who were implanted with a Günther Tulip or Celect filter between July 2007 and May 2009. After 71 days, all 27 Celect filters had some degree of perforation into the vena caval wall. Overall, 86% perforated the vena cava and 40% tilted into the vena cava.
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.
FDA Warning
When retrievable IVC filters are not removed after 3-4 months, the risk of complications increases significantly. In 2010, the FDA reported receiving nearly 1,000 adverse event. In some cases, adverse events may have been caused by retrievable filters remaining in patients who were no longer at risk of pulmonary embolism.
According to the Safety Communication:
“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients.”
Do I have a Cook Celect Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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