IVC filters present risk of potentially fatal complications
IVC filters are implanted into the vena cava, which is primary blood vessel responsible for returning blood to the heart from the lower body. These filters are implanted into patients who have issues with blood clots, but do not respond to the usual treatment of blood-thinning medications. They are meant to prevent pulmonary embolisms that result from a blood clot breaking free and traveling to the heart and lungs. The device has also been used for patients during weight loss surgery due to their heightened risk of developing blood clots. These filters are designed to be retrievable after the risk of pulmonary embolism has passed.
A fractured IVC filter can not only perforate the immediate area of the vena cava, but the metal fragments can migrate around the body and cause damage to other organs, often the heart and lungs, leading to bleeding, severe pain, further embolus, and other potentially fatal complications. A warning from the FDA has indicated that 921 reports of adverse events caused by IVC filters. Of those, 146 cases involved filters coming loose, 328 involved the filter coming loose and migrating to other parts of the body, 56 involved the filter fracturing, and 70 were cases of the interior vena cava being punctured.
Study highlights hazards of Bard’s Recovery and G2 filters
The Archives of Internal Medicine published a clinical study indicating the high failure rate of C.R. Bard’s Bard Recovery and Bard G2 IVC filters, in addition to the FDA warning. The research found Bard’s IVC filter issues to be both common and severe, sometimes leading to fatalities. The Bard Recovery presented a failure rate of 25%, including complications where shards of the filter travel to a patient’s heart, causing near-fatal or fatal results. The Bard G2 filter presented a failure rate of 12%, involving the fracturing and migrating of the filter through the patient’s body.
Complications with these IVC filters could require open-heart surgery, and researchers have indicated that patients with the filter typically have a higher mortality rate than the general population, causing them to be more vulnerable to IVC filter issues.
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