The Cook Celect IVC filters and Cook Gunther Tulip IVC filters have been linked to an increased risk of failure and migration, which could cause serious injury or death if the arms or struts of the inferior vena cava (IVC) filters fracture or break free inside the body.
COOK IVC FILTER LAWSUIT STATUS: Lawyers are providing free consultations and claim evaluations for Cook Celect IVC filter lawsuits and Cook Gunther Tulip IVC filter lawsuits to help individuals determine if they may be entitled to compensation as a result of problems with a vena cava filter.
MANUFACTURER: Cook Medical.
OVERVIEW: Inferior Vena Cava (IVC) filters are small devices designed to catch blood clots that may break free from lower parts of the body and travel toward the lungs. They are implanted in patients who are at risk for a pulmonary embolism, when they are unable to take anticoagulants or when those medications have failed.
In August 2010, the FDA issued a warning to doctors, alerting them about the risk of problems with retrievable IVC filters, such as the Bard Recovery and G2 filters. The agency indicated that the IVC filters should be removed in many cases once the danger of a pulmonary embolism has passed.
At least 900 adverse event reports have been received by the FDA involving complications from IVC filters. One of the most common complaints is of the filter, or a piece of the filter, breaking off and migrating through the patient’s body.
COOK CELECT AND COOK GUNTHER TULIP IVC FILTERS: A study was published in the April 2012 issue of CardioVascular and Interventional Radiology which found that all Celect and Gunther Tulip filters showed some degree of vena caval perforation after just 71 days. The researchers found that full perforation of at least one component all the way through the IVC wall occurred in 86% of all cases. The filters were found to have tiled in 40% of cases.
Like the FDA, the researchers called for the removal of IVC filters as early as clinically indicated. They also called on doctors to take a close look at IVC filters during follow-up imaging scans.
BARD IVC FILTER FAILURES AND PROBLEMS: The Bard Recovery IVC filter was approved in 2002 and placed on the market in 2003. Although the company indicated plans for “long-term success” when the filter was introduced, it was removed from the market just over two years later in October 2005.
While a Bard Recovery IVC filter recall was never officially issued, the Bard G2 IVC filter was introduced as a replacement product, reportedly providing “enhanced fracture resistance”, “improved centering” and “increased migration resistance.” However, both Bard IVC filters have been found to be prone to fractures and failures. Studies have confirmed that the Bard Recovery IVC filter and Bard G2 IVC filter have a particularly high rate or failures and other problems that could cause serious and potentially life-threatening injuries.
Pieces of the IVC filters appear to be prone to break or fracture, allowing pieces to flow through the bloodstream travel to the heart, lungs or cause other internal punctures.
According to an August 2010 study published in the Archives of Internal Medicine, the Bard Recovery Filter system failure rate was 25% and the Bard G2 Filter system failure rate was about 12%. Researchers recommended an immediate halt to the use of the Bard IVC filters to protect patients.
LAWSUITS OVER BARD IVC FILTER FRACTURES: If a Cook IVC filter fractures in a patient’s body the filter, or parts of it, can migrate causing internal injuries including:
- Perforation of the heart
- Perforation of the lungs
- Hemorrhagic pericardial effusion (blood around the heart)
- Cardiac tamponade (disruption of the heart caused by excess fluid)
- Ventricular tachycardia (accelerated heart beat)
- Puncturing of the vena cava
In many cases, the problems require emergency treatment for the Cook IVC filter removal, which may result in open heart surgery in some cases. Through a Cook IVC filter lawsuit, individuals who have experienced a fracture, failure or migration of their device may be able to obtain compensation from the manufacturer as a result of the allegedly negligent and defective design of these products. Cook IVC filter lawyers are providing free consultations and claim evaluations for individuals throughout the United States.