IVC, or Inferior Vena Cava Filters, are small, metal cage-like devices that are implanted in the veins to catch blood clots before they reach the heart or lungs. They are generally used in patients with emergency blood clot risks or those who can’t tolerate anticoagulant medications.
The filters are usually implanted by a vascular surgeon, although it is no longer necessary to perform surgery to do so. They can be placed in the inferior vena cava, the largest vein in the body, simply by making a small incision in the groin or neck.
IVC filters are designed to be either removable or permanent, depending on the length of time the blood clot risk will last. However, the FDA has warned that many temporary filters have instead been left in place.
Now, the FDA has received more than 1,000 reports of patient injury or death from IVC device breakage, migration or vein perforation, and a new report suggests a leading manufacturer may have hidden their risks.
Experts have warned that IVC blood clot filter implants made by Bard & Cook may cause severe or fatal side effects.
IVC blood clot filters are used in an estimated 250,000 patients each year.
A special federal court has convened to handle growing litigation for those affected.
New report shows a leading IVC maker may have hid their dangers.
The dangers of IVC filters center around the risk that the metallic arms of the devices will perforate through the venous wall, that the devices will move through the vein, or, worst of all, that a small piece of the metal device will break off and travel into the heart or lungs.
After Bard released the Recovery IVC filter in 2003, reports indicate the company became aware the device had significant risks for fracture or vein perforation. However, instead of issuing a recall, they simply replaced it with a slightly better version, the G2, in 2005.
By August of 2010, the U.S. Food and Drug Administration issued a warning to physicians working with the devices that the agency had received an alarming number of reports of complications among patients in the 5 previous years.
In July of 2015, the FDA sent a warning letter directly to Bard, notifying the company that it had violated agency rules with regard to misbranding, device cleaning, failing to report patient side effects, and mislabeling severe injuries or deaths as simply “device malfunctions.”
IVC filters have been sold under several different brands, including:
If you received any of these implants, it is important to speak with your doctor about whether you are a candidate for removal as soon as possible.
Recent studies have shown that between 12% and 31% of all Bard IVC filters implanted may fail, causing the potential for serious patient injury or death.
Although design improvements in the later models have made them slightly safer, all patients should still be aware of the risks of these products, and talk with their doctor about their options for removal.
In 2005, doctors from the New England Society for Vascular Surgery examined data from the FDA adverse event reporting system that indicated nearly 32% of Bard Recovery IVC filters might experience fracture or breakage of their metal arms.
In 2008, the Journal of Vascular and Interventional Radiology published a study showing as many as 36% of Bard Recovery IVC filters suffered breakage, with 21% of patients experiencing migration of the broken pieces toward the heart or lungs.
Then, a Pennsylvania hospital study released in 2010 in the Archives of Internal Medicine was the first to track the failure rate of both the older Bard Recovery filters and the newer Bard G2 filters.
Overall, researchers found that 16% of the Bard filters experienced a breakage of metal components, with the older filters failing approximately twice as often. In almost 9% of patients, the metal fragments traveled into the heart. One patient even died during the study.
While most FDA and media attention has focused on the failure rate of filters made by Bard, the Celect and Gunther Tulip brand IVC filters sold by Cook Medical may actually have higher risks for vein perforation.
In studies published as early as 2009 by the Journal of Medical Imaging and Radiation Oncology, doctors found that a significant number of patients implanted with Cook Celect filters experienced perforation or embedment into their inferior vena cava wall.
In 2012, a study from Cardiovascular and Interventional Radiology found that 100% of test patients experienced vein perforation from Cook Celect IVC filters after a period of 71 days.
Now, a study published in June 2015 by the Journal of Vascular Interventional Radiology has concluded that 43% of Cook IVC filters result in vena cava perforation.
A recent NBC News report found that Bard may have known the dangers of their Recovery IVC filter as early as 2003. However, instead of issuing a recall, they continued selling over 34,000 units until 2005, when they phased it out for the only slightly safer G2 model.
The NBC report also suggests Bard may have concealed the dangers of their IVC filters from doctors and the public, and even forged the signature of a regulatory advisor in order to gain approval of the device from the FDA.
Now, a growing number of patients have filed lawsuits against Bard and Cook Medical over side effects suffered from their IVC filters. Due to the volume of these cases, they have been consolidated into special federal courts for quicker handling.
So far, more than 117 patients have filed claims against Cook Medical for injuries suffered from the Celect and Gunther Tulip filters. The U.S. Judicial Panel on Multidistrict Litigation has centralized these cases into federal multidistrict litigation court (MDL) 2570 in the Southern District of Indiana under Chief District Judge Richard Young.
In August, the JPML also consolidated the rising number of IVC claims against Bard into MDL 2641 under U.S. District Judge David Campbell in the Arizona federal district. That case is known as IN RE: Bard IVC Filters Products Liability Litigation.
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FDA: Removing Retrievable Inferior Vena Cava Filters: Initial Communication. (August 9, 2010). Retrieved from www.fda.gov
FDA: Warning Letter to C.R. Bard. (July 13, 2015). Retrieved from www.fda.gov
Hull, J. et al. Bard Recovery Filter: Evaluation and Management of Vena Cava Limb Perforation, Fracture, and Migration. Journal of Vascular and Interventional Radiology. (November 2008). Retrieved from www.jvir.org
Nicholson, W. Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. National Institutes of Health. (November 8, 2010). Retrieved from www.ncbi.nlm.nih.gov
Doody, O. Initial experience in 115 patients with the retrievable Cook Celect vena cava filter. Journal of Medical Imaging and Radiation Oncology (February 2009). Retrieved from www.ncbi.nlm.nih.gov
Durack, J. Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters. Cardiovascular and Interventional Radiology. (April 2012). Retrieved from www.ncbi.nlm.nih.gov
Ryu, R. A Comparison of Retrievability: Celect versus Option Filter. Journal of Vascular Interventional Radiology. (June 2015). Retrieved from www.ncbi.nlm.nih.gov
Sandler, T. Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw? NBC News. (September 3, 2015). Retrieved from www.nbcnews.com