Bard and Cook - IVC Filters: Worse than Dangerous, They’re Useless

Posted on Friday, February 19, 2016

A research study published in the October issue of Annals of Surgery reports that IVC filters are not only injuring and killing people, they’re doing so while offering no benefit to patients. The study, which was carried out at the University of Michigan, examined data on over 800 patients with IVC filters implanted between 2010 and 2014.

IVC filters were designed to prevent blood clots from entering the lower chamber of the heart and traveling to the lungs. The device looks like a spider and is implanted into the largest vein in the body, leading from the lower extremities to the heart. The filter is used primarily for patients who are at risk for what is known as deep-vein thrombosis (DVT) but off label uses of IVC filters are common. DVT is where a blood clot forms in one of the limbs (usually a leg), and is in danger of breaking loose and traveling to the lungs, thus blocking blood flow. Patients who have had joint surgery are at particular risk for this condition, since they are usually unable to move for extended periods. Although IVC Filters are intended to treat a temporary condition - until the danger of an embolism has passed - the filters are extremely difficult and dangerous to remove.

IVC filters are associated with very high failure rates. Once implanted, they often break, sending small, jagged pieces of metal through the bloodstream. The results are serious, and in some cases, fatal. What is more, evidence has emerged in recent months showing that Bard executives knowingly and intentionally concealed these dangers up to the point of committing criminal fraud in order to get their product to the market.

Today, medical researchers have discovered that the IVC filter is actually useless – and in reality, actually exacerbates the condition it was designed to treat. Results show that the majority of patients who had an IVC filter implanted were far more likely to suffer DVT - but the presence of the IVC filter find nothing to reduce the risks of an embolism. The researchers’ conclusion: High rates of prophylactic IVC filter placement have no effect on reducing trauma patient mortality and are associated with an increase in DVT events.

To date, there have been 27 fatalities and thousands of non-fatal injuries, including organ penetration, attributable to the IVC filter. The FDA eventually obtained sufficient information to issue a warning about the device and its propensity to break and migrate in 2010. While the warning stopped short of ordering doctors to stop using them, it did recommend that the IVC be removed as soon as a patient was recovered and no longer in danger of suffering an embolism. Unfortunately, the IVC design and implant guidelines do not lend themselves to such removal leaving many patients at risk for years. To date, more than 200,000 of these ticking time bombs have been implanted in patients throughout the United States.

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