Organ perforation is a rare but severe complication of the IVC filter. Studies estimate that up to 25% of people implanted with an IVC filter suffer a perforated inferior vena cava. Although this does not always cause symptoms or health problems, if the IVC perforates an internal organ (the aorta, intestines, blood vessels, etc), the condition can be life-threatening. Surgery is usually necessary to correct the condition.
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IVC Filter Perforation
The popularity of IVC filters has grown dramatically in the last twenty years, mostly due to the advent of recoverable IVC filters. Unfortunately, these retrievable IVC filters are associated with a higher risk of perforation than permanent implants.
An IVC filter is a medical device implanted in the inferior vena cava (IVC) to “filter” blood clots before they can reach the lungs and cause a pulmonary embolism. They are designed with thin wires, usually arranged in a cone-shape. The thin wire legs (or “struts”) of the device can erode into the inferior vena cava, perforate it, and then perforate an abdominal organ.
It is estimated that 9-25% of IVC filters perforate the inferior vena cava. This complication is most serious when the filter also perforates an internal organ (such as the aorta, heart, intestines, etc.). Perforation may occur suddenly during insertion, but more often occurs gradually over several months or years.
Another serious complication occurs when the filter fractures or migrates. In these cases, pieces of the filter can perforate the heart, lungs, or other internal organs. Surgery is almost always necessary.
FDA Warnings for IVC Filter Perforations
In 2010, the U.S. Food and Drug Administration (FDA) published a Safety Communication after receiving 921 adverse event reports linked to IVC filters. The agency received 70 reports of IVC filter perforation. The agency warned that the risk of complications was greatest when patients were implanted with removable IVC filters, but then never had the devices removed. They recommended that physicians should remove the device when the patient’s risk of a pulmonary embolism subsided.
Studies of IVC Filter Perforation
In February 2012, researchers published this study. They warned, “Filter leg perforation occurs very frequently,” and furthermore, up to 37% of certain filters could cause a perforation.
In 2002, the Journal of Vascular Surgery published this study, warning that “the risk of erosion or perforation is estimated to be as much as 25%”.
In August 2012, surgeons published this report, which described the treatment of a patient who suffered a rare perforation of both the aorta and intestines (duodenum).
In August 2012, surgeons published this report, describing a patient who suffered a perforation of the aorta. They estimated that 9-24% of patients with an IVC filter suffer a perforated inferior vena cava.
Complications of IVC Filter Perforation
Not all cases of IVC filter perforation are life-threatening. In fact, many people are asymptomatic and never have health problems. Serious complications typically occur when the filter also perforates an internal organ. The most commonly perforated organs include:
- Aorta: A large blood vessel that exits the heart and carries oxygen-rich blood to the body
- Duodenum: This is the upper part of the small intestine, just after the stomach.
- Ureter: This is the duct that passes urine from the kidneys to the bladder.
- Retroperitoneal: This is a perforation of the abdominal space behind the peritoneum, which is the membrane that lines the abdominal cavity and covers the organs.
Cook Celect IVC Filter Perforation
Several studies have linked the Cook Celect IVC filter and perforation. One study published in June 2015 linked it to a 43% rate of strut perforation, compared to 0% for the Rex Medical Option IVC filter.
In 2012, Cardiovascular and Interventional Radiology published a study in which all 27 patients implanted with a Celect filter experienced some degree of perforation into the vena caval wall after 71 days.
In 2009, a study involving 115 patients implanted with the Celect filter warned about high rates of erosion into the vena caval wall. In some cases, this made retrieval of the filter more complicated.
IVC Filter Lawsuit Information
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