Inferior vena cava (IVC) filters are small medical devices that are placed into the inferior vena cava, a large vein carrying blood into the heart, to prevent blood clots from reaching the lungs in order to avoid pulmonary embolisms (PE), which can be fatal.
IVC filters are often placed in those at risk for blood clots who cannot use or are unresponsive to anticoagulant (anti-blood clotting) approaches. There are several manufacturers of IVC heart filters that create filters within the following two categories: permanent filters and temporary filters.
Permanent IVC Heart Filters
Permanent IVC filters are designed for long term use of preserving the inferior vena cava while preventing a sudden blockage.
Currently, there are eight different brands of IVC permanent filters approved by the Food and Drug Administration (FDA):
- Cook’s Bird’s Nest Filter
- Cook’s Gunther Tulip Filter
- Braun’s Vena Tech LGM Filter
- Braun’s Vena Tech LP Filter
- Bard’s Simon Nitinol Filter
- Cordis Corporation’s TrapEase Filter
- Boston Scientific’s Titanium Greenfield Filter
- Boston Scientific’s Over-the-Wire Greenfield Filter
Permanent IVC filters were shown to decrease pulmonary embolism within 12 days. However, no benefits were detected with the long term use of IVC filters and studies showed that the longer the permanent filters remained, the more likely a patient would form a blood clot inside a vein deep within the body.
Temporary IVC Heart Filters
In order to prevent such an injury, the FDA recommends the removal of IVC filters within 29-54 days of insertion. Further, the FDA notes that complications can often be avoided if the IVC filters are removed once the risk of blood clotting in the arteries of the lungs has decreased.
Due to the want of removing IVC filters earlier for the sake of the patient, more temporary filters developed over time.
There are currently eight temporary, or retrievable, filters available within the IVC filter marketplace:
- ALN Implants Chirugicaux‘s ALN optional vena cava filter
- Bard’s G2 vena cava filter
- Bard’s G2 X vena cava filter
- Bard’s Eclipse vena cava
- Cook Medical’s Günther Tulip vena cava filter
- Cook Medical’s Celect vena cava filter
- Cordis’ OptEase retrievable vena cava filter
- Rex Medical’s Option retrievable vena cava filter
Known issues and complications associated with IVC Filters
Despite the brevity of time within the body, retrievable IVC filters are reported to create adverse events such as device movement, breaking apart within the vein, relocation into or fracturing within the heart and lungs, perforating the body, or extreme difficulty to remove.
Bard Peripheral Vascular, Inc. in particular has been noted for its IVC filter complications and adverse events. On August 9, 2010, the FDA issued an advisory to physicians that retrievable filters manufactured by Bard required immediate removal and reissued its advisory on May 6, 2014.
If you or a family member has been harmed by an IVC filter, consulting an attorney who specializes in medical device malfunctions can help ensure that your legal rights are protected.
Use Legal Advocate Link to find a local attorney today.