Problems with the designs of certain inferior vena cava (IVC) filters have caused many individuals nationwide to suffer severe complications and injuries when the small devices fractured or broke inside the body.
Inferior Vena Cava (IVC) filters, or blood clot filters, are small devices designed to catch blood clots that may break free inside the deep veins of the body and travel toward the lungs. The spider-like filters 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 those manufactured by Cook and C.R. Bard. The agency indicated that the blood clot 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.
In May 2014, the FDA issued an updated safety statement indicating that patients may face an increased risk of problems with IVC filters the longer they remain in place, advising doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation.
Due to improper warnings and instructions, many doctors were not aware of the importance of removing the IVC filters. In addition, design problems with certain products may increase the risk of IVC filter failures, including fractures of the device, perforation of the vena cava or other injuries.
In April 2015, a study published in the Journal of the American Medical Association (JAMA) found that IVC filters were not as effective as blood thinners at preventing pulmonary embolism. The researchers found that filter recipients were twice as likely to have a blood clot travel to their lungs than those on blood thinners.
A study published in August 2015 in a letter in JAMA warned that the long-term risks of IVC filters may negate any health benefits they provide in catching blood clots.
The FDA issued a warning letter to Bard in July 2015 for illegally marketing a device used to remove the Recovery IVC filter, as well as for problems with its Denali IVC filter.
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 Cook 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.
In October 2014, all Cook Medical IVC filter lawsuits were centralized as part of an MDL in U.S. District Court for the Southern District of Indiana for pretrial proceedings.
Researchers from the University of Colorado revealed in March 2015 that rates of IVC filter perforations were significantly higher with the Cook Celect than with competing IVC filters.
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.
In August 2015, all Bard IVC filter lawsuits involving the G2 and Recovery IVC filters were centralized as part of an MDL in Arizona federal court for pretrial proceedings.
If an 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 blood clot filter removal, which may result in open heart surgery in some cases. Through an 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. IVC filter lawyers are providing free consultations and claim evaluations for individuals throughout the United States.
If you or a loved one have been harmed by using an IVC Filter, contact us immediately by calling 601-948-8005 or by going to our website and filling out our contact form or use the live chat. There is no fee to discuss your case, and you could be eligible for compensation. You can learn more about IVC Filter’s here.