Inferior Vena Cava (IVC) filters are small cone-shaped devices deigned to catch an embolism, or a blood clot that has broken off from a deep vein in the legs before it reaches the lungs or heart. The IVC filter is implanted in the inferior vena cava, a large vein located just below the kidneys. Without the filter, the embolism could create a blockage in the pulmonary artery, also known as a pulmonary embolism. This could lead to chest pain, difficulty breathing, and even death.
The risk of blood clots greatly increases after undergoing surgery or suffering a serious injury, leading doctors to use IVC filters when a patient is unable to take blood thinners. Some of the more common cases where a doctor would recommend implanting an IVC filter include:
- Cancer treatment or diagnosis
- Car accidents
- Dialysis treatment
- Emergency surgeries
- Gunshot injuries
- Serious falls
- Spinal cord injuries
- Stabbing injuries
While IVC filters provide an often necessary treatment to potentially deadly pulmonary embolisms, they don’t come without risks. Of the three types of IVC filters that can be implanted — permanent, optional, and retrievable — the U.S. Food and Drug Administration (FDA) warns that the retrievable filters come with serious potential risks. They reported 921 adverse events from 2005 to 2010 that fell into four separate categories:
- Device migration: An estimated 35 percent of adverse effects involved device migration. They can migrate to another part of the inferior vena cava, the pulmonary overflow tract, or even to the heart. In these types of cases, surgery may be required to remove the device.
- Detached device components (also called device embolization): The FDA listed this as the second most frequently reported complication. This can lead to increased issues with device retrieval, and can also lead to further damage.
- Filter fracture: While fractured filters usually don’t lead to many issues, if they remain untreated, can lead to greater damage.
- Filter perforation: Filter struts have been found to cause aortic penetration, duodenal penetration, and ureteral penetration. Laceration of a lumbar vessel has also been found to potentially cause significant bleeding, and complete filter perforation has also been found to cause significant morbidity.
The FDA recommends removing these retrievable IVC filters within 54 days of implantation if the risks of pulmonary embolisms have subsided. They warn that, if left in the body for too long, the more difficult they may become to remove, increasing the risk for complications.
According to a study looking at IVC filter’s failure rate in the Journal of the American Medical Association (JAMA) conducted in 2013, only 58 out of 679 retrievable IVC filters were actually removed. Over 18 percent of attempts at removing the filters left implanted for longer than medically necessary failed, nearly 8 percent of the patients suffered venous thrombotic events, and 25 patients sustained pulmonary embolisms.
There are various lawsuits against manufacturers Cook Medical and C.R. Bard, claiming breach of implied warranty, design defects, failure to warn, manufacturing defects, negligent misrepresentation, and negligence. The five products notably listed in the lawsuits include:
- The Bard G2 filter
- The Bard G2 Express filter
- The Bard Recovery filter
- The Cook Celect filter
- The Cook Gunter Tulip filter
If you or a loved one experienced adverse side effects relating to an IVC filter, it may be in your best interest to seek legal advice and representation. Our medical malpractice attorneys at the Domina Law Group pc llo have been serving clients in Nebraska and throughout the country, with multi-million dollar case results in 11 different states. Contact us today for a case evaluation, or call us at (888) 387-4134 to set up your appointment.
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