February 5, 2016 · FLEMING | NOLEN | JEZ, L.L.P.
A research study published in the October issue ofAnnals of Surgery reports that the IVC Filters are not only injuring and killing people, they’re doing so while offering no benefit whatsoever to patients. The study, which was carried out at the University of Michigan, examined data on over 800 patients who had received IVC Filters between 2010 and 2014.
The IVC Filter was designed to prevent blood clots from entering the lower chamber of the heart and traveling to the lungs. Resembling a spider, the device 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). This is a condition in which 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 they are intended for temporary use until the danger of an embolism has passed, IVC Filters are extremely difficult and dangerous to remove.
IVC Filters are associated with high failure rates. Once implanted, they are known to 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 were not only aware of the dangers but chose to conceal this information.
Now, medical researchers have discovered that the IVC Filter is actually useless – and in fact, actually exacerbates the condition it was designed to treat. Results showed that the majority of patients who had an IVC Filter implanted were far more likely to have DVT – but the presence of the IVC Filter did nothing to reduce the risk 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 well over a thousand more non-fatal injuries attributable to the IVC Filter. The FDA did eventually issue a warning about the device in 2010 of its propensity to break and migrate, resulting in organ perforation. 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. However, many patients have had them for years.