The Food and Drug Administration has put out a warning to doctors to remove inferior vena cava (IVC) filters from patients after the danger of the clot has passed, with the fear that the device may fracture and migrate inside of the patient.
Inferior Vena Cava (IVC) Filters are devices that are used to prevent blood clots from traveling to the lungs or heart and causing a pulmonary embolism. Studies have shown that pieces of defective IVC filters are known to break off and migrate to organs resulting in punctures, life threatening conditions, and even death. According to the
FDA more than 900 reports of problems associated with IVC filters since 2005.
- 328 : device migration
- 146 : embolizations (detachment of the device)
- 70 : perforation
- 56 : filter fracture
Side-Effects
IVC Filters are meant for short-term placement, but are not always removed after the patients risk for PE has passed.
Long term risks may include:
- Severe and reoccurring pain in the heart or other parts of the body
- cardiac tamponade (bleeding in or around the heart)
- pulmonary embolus (blockage of a blood vessel in the lungs by blood clots)
- hematoma (blood the collects under the skin or in an organ)
- perforation or puncturing to the vena cava wall and the heart
- perforation or puncturing to lungs, respiratory compromise, internal bleeding, infection
- other serious complications/injuries and death
Research
Recently a study was released by the
Archives of Internal Medicine concluding that the "Bard Recovery and Bard G2 filters had high
prevalences of fracture and embolization, with potentially life-threatening
sequelae." The investigation allowed for researchers to look at 80 patients who received the Bard Recovery Filter (first generation) or the Bard G2 Filter. The devices were available between 2003 and 2005. According to the study [
See Study Here]:
- 16% of patients saw at least one strut fracture
- 1 in 7 of 28 first generation filters were found to fracture and embolize
- in 5 or the 7 cases, patients had a fragment travel to the heart
- 3 patients experienced life threatening symptoms: ventricular tachycardia and sudden death
- 6 of 52 Bard G2 filters fractured
- in 2 of the 6 cases, patients experienced fragments traveling to organs
Lawsuits
Bard IVC filter lawsuits have been filed. If you have had a Bard IVC filter implant and experienced injuries due to the fragmentation and migration of this device, contact our lawyers for a free case evaluation.
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