IVC filters are inserted into the inferior vena cava (IVC) for those who have experienced blood clots in the legs or pelvis. The IVC Filter is meant to keep these blood clots from traveling to the lungs and heart, where they can be much more dangerous.
Unfortunately, the negligent design and manufacturing of many of these tiny devices have caused them to:
- Move from their intended location
- Become fractured or broken
- Move toward the heart or lungs
- Puncture or tear the IVC
- Become difficult to remove
They may also lead to lower limb deep vein thrombosis (or blockage) and IVC occlusion (constriction or blockage). Ultimately, these devices can lead to difficulty breathing, stroke, and even death.
About IVC Filters
The IVC filter itself is extremely small. It looks like a cage, spider web, or umbrella. It is specifically designed to stop blood clots from moving through the IVC. The IVC is the main vessel that moves blood toward the heart and lungs from the lower half of the body. Generally, these devices are only used when anticoagulant therapy has not been effective or cannot be used for one reason or another.
Most IVC filters are designed to be a permanent implant, but there are temporary versions as well. The temporary versions seem to cause the most problems, particularly when they should be removed. The Food and Drug Administration (FDA) states that removing the temporary IVC filter as soon as the risk has subsided will generally help combat the negative side effects of the devices.
IVC filters are used to combat the risk of pulmonary embolism (PE). The risk of PE is higher in those who have recently experienced:
- Heart attack
- Vascular disease
- Fractured leg or pelvic bones
- Trauma to the legs
- Hip, knee, or other joint replacements and other related joint surgeries
- Lung conditions
Generally, the IVC filters are supposed to be removed as soon as the heightened risk of PE has subsided, but in many cases, this is not occurring. Failure to remove these devices significantly increases the risk of severe medical problems.
FDA IVC Filter Information
IVC filters have been in use since the 1960s, but they were originally designed to be a temporary solution to blood clot problems. In 2010, the FDA issued a safety notice regarding the risk of IVC filters and long-term use. The FDA explained that since 2005, it has received 921 negative reports that involved IVC filters.
It concluded that the risk increases if the user allows the IVC filter to remain in place after the risk for pulmonary embolism (PE) has ended. PE means that there is a blockage of one of the pulmonary arteries in the lungs.
The FDA updated this notice in 2014 with much of the same information, discouraging patients from using these devices long term and having them removed as soon as the threat of PE has ended.
Studies Show Serious Problems With IVC Filters
A study by Dr. William Nicholson in Pennsylvania conducted follow up appointments with 80 patients who previously had IVC filters implanted. His findings were disturbing. They found that IVC filter fragmentation and embolization occurred in:
- 25% of those who used the Bard Recovery filter
- 12% of those who sued the Bard G2 filter
- Fractures generally occurred roughly 37 months after implantation
Experts estimate that nearly 7,000 Americans have unknown fragmentation that could cause serious problems at any time, without warning. In fact, one of the patients in the study actually died suddenly after completing the study, likely from the relatively minor chest pain and heart problems he was experiencing.
Like the FDA statement, the study concluded that the potential for fracture was directly related to the time that the IVC filter remained in the body.
IVC Filter Complications
Although the FDA does not target any one brand specifically, several IVC filter brands have been the subject of litigation. Some of these types of filters include:
- Bard Recovery filter
- Bard G2 filter
- Bard G2 Express filter)
- Gunther Tulip Vena Cava Filter
- Gunther Tulip Mreye
- Cook Celect Vena Cava Filter
- Cook Celect Platinum
- Cordis OptEase IVC filter
- ALN IVC filter
- Rex Medical Option IVC filter
Most IVC filters are from either C.R. Bard, Inc., Bard Peripheral Vascular, Inc., Cook, Inc., Cook Medical LLC, or William Cook Europe ApS. The FDA has not recalled any of these devices specifically, however.
IVC Filter Lawsuits
Several lawsuits have begun, alleging that the IVC manufacturers knew or should have known about the potential dangers of IVC filters, particularly as a long-term solution. A number of multidistrict litigation IVC filter lawsuits are currently pending across the United States. The cases allege that the devices are dangerous and that patients and medical professionals were not adequately warned of these dangers.
In fact, in one case against the Bard, there is evidence that Bard’s research indicated that there was an unreasonable danger to patients of device fracture. Bard allegedly did not show the results of this study to the FDA nor do anything to correct the potential issues. Instead, they continued to sell and market the potentially defective device while they designed a new, more effective version. This desire to place profits ahead of public safety is unacceptable.
Contact an IVC Filter Lawyer
If you or a loved one has an IVC filter implanted, it is best to speak to a medical professional about the risk associated with keeping the device in your body. If your heightened risk of PE has passed, it may be time to remove the device. Talk to your doctor about the specifics of your individual situation.
If you or a loved one has already experienced negative side effects or complications associated with your IVC filter implant, call The Dixon Injury Firm to discuss your case. You may be entitled to compensation to help with medical bills, pain and suffering, and any loss of function or enjoyment of life that you or your loved one has experienced.
The effects of this device can be severely debilitating and you should not have to face these problems alone. Call (855) 553-2337 for a free case evaluation today.