Suffering from IVC Filter Injuries? Let our lawyers help you
If you your IVC filter was removed after it broke, or its fragments perforated your organs causing an injury, you may qualify for monetary compensation.
Are IVC filters dangerous?
Inferior Vena Cava (IVC) filters are medical devices used to trap blood clots whose safety and effectiveness has been questioned because of their dangers. The device consists of a tiny metal cage usually employed as an alternative in all patients who cannot be treated with traditional anticoagulant therapy with blood thinners such as antiplatelet drugs, heparins, warfarin or the Novel Oral Anticoagulants (NOAC). If a thrombus (blood clot) reaches the heart, lungs or brain it may cause serious complications such as excruciating pain, difficulty breathing, stroke and even death. Vascular filters should prevent this damage by trapping the blood clot and keeping it in place until it’s slowly dissolved. Although usually an IVC is retrieved within two months after its placement, some of them are implanted permanently.
Are IVC filters safe and effective devices?
IVC filters manufactured by C. R. Bard such as the Bard Recovery and Bard G2 filter are dangerously prone to breakage, fragmentation, and migration. Data from a study published in 2010 in the journal Archives of Internal Medicine showed that one Bard filter in four fractured and traveled to a nearby organ (usually the heart) causing a life-threatening embolism. Metal fragments can have potentially lethal consequences such as organ puncturing and perforation, internal hemorrhages, and serious bleedings. A second research published in 2012 in the Journal of Vascular and Interventional Radiology provided evidence showing that up to 40% of the devices fractured within 5.5 years since they were implanted. In several instances, the “metal cage” migrated after being improperly placed, forcing the patient to undergo multiple surgeries in order to retrieve it. Another study showed similar failure percentages for the Günther Tulip and Celect retrievable filters manufactured by Cook Medical.
In 2013, a study published in the Journal of the American Medical Association (JAMA) questioned the safety and effectiveness of the already controversial IVC filters. Researchers examined a total of 952 subjects who were implanted with the vascular filters and found that 74 of them (7.8 percent) still suffered from pulmonary emboli and other thrombotic events. The study also found that almost one retrieval attempt out of five (18.3%) was unsuccessful, forcing surgeons to reoperate the patient to remove the implant. Although IVC filters are indicated only in patients who can’t tolerate treatment with anticoagulants, one-quarter of the subjects still received blood thinners after they were discharged from the hospital. Researchers concluded that since the use of the device was associated with an unsettlingly high rate of thromboembolic accidents, its effectiveness was “suboptimal.” To date, only one trial allegedly demonstrated that these medical devices could reduce the risk of pulmonary embolism, but all the patients controlled during this study were on anticoagulant drugs too.
In less than five years, the FDA received 921 adverse reaction reports filed by patients who suffered the consequences of device migration (328 cases), perforation of the inferior vena cava (70 cases), embolizations after detachment of device components (146 cases), and filter fracture (56 cases). In 2010 the agency released a safety alert announcement about the risks associated with the use of IVC Filters and determined that they should be used only for short-term placement or until the risk of PE subsided. After finding that many retrievable blood clot filters were kept inside patients’ bodies for years, in 2014 the FDA updated the recommendation explaining that the devices should be removed between the 29th and 54th day after implantation. In July 2015, the FDA issued a warning letter to Bard to recall a device used to remove the Recovery IVC filter which was marketed illegally as well as for several quality system regulation violations for the Simon Nitinol, Eclipse, and Denali Filters.
Article written by Dr. Claudio Butticè, Pharm.D.