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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