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What models of retrievable IVC filters are under scrutiny?
C.R. Bard Inc. brands: Recovery, G2, G2 Express, Eclipse, Meridian, Denali
Cook Medical Inc. brands: Celect, Gunther Tulip
IVC filters can migrate and fracture, causing injury or death
In 2010, the FDA warned about the risks of fracture, migration, and perforation from retrievable filters. The agency advised for the devices to be removed as soon as the risk for blood clots was no longer a concern, and recently updated the advisory, calling for removal between the 29th and 54th day after implantation.
Problems from IVC filters include:
- Migration: Migration means the device becomes loose from the location where it was implanted and moves toward the heart and lungs. Migration can render the filter ineffective at stopping blood clots. Migration into the heart and lungs can cause immediate death.
- Fracture: The “legs” or “arms” of the device have been known to break spontaneously and also break during attempted removal procedures. The fractured pieces of metal can then travel throughout the body, where they can puncture organs or become lodged in the heart or lungs. It is extremely difficult to remove pieces of an IVC filter after it has fractured. Many patients must have subsequent surgeries to remove the broken filter pieces.
- Puncture causing "bleed out": The "fishhook" anchors and fractured pieces have been known to puncture some patients' inferior vena cava and cause internal bleeding. Some patients with these problems think they are simply not feeling well, and can die within hours or days if the problem is not diagnosed.
- Puncture causing paralysis and neurologic injury: Some IVC filters have been known to pierce through the inferior vena cava into the spinal canal and cause paralysis and injury.
Studies and investigations associated with IVC Filters
A number of medical studies have shown the risks of retrievable IVC filters. These include: