Inferior vena cava (IVC) filters sold by Bard have been found to have a high failure rate in a study published in the Archives of Internal Medicine.
IVC filters are implanted in patients to help prevent pulmonary embolism due to blood clots moving into the lungs. Patients who receive IVC filters such as the Bard Recovery and the G2 by Bard are often patients who are either unresponsive or unqualified due to other medical problems for anti-coagulant drugs.
The tiny vena cava filters are shaped similarly to a cone with legs that extend to catch blood clots. When these legs break off the pieces or the entire filter can migrate through the body to affect other body parts, perforate veins and even cause sudden death. The result of this study caused the FDA to take notice of the dangers involved in using IVC filters and issued a warning to physicians to monitor their patients and remove the filters once the risk of blood clotting has passed.
The FDA issued a communication on this:
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm
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