Pulmonary embolism (blockage of an artery in the lungs) kills 100,000–180,000 Americans each year. Risk factors for pulmonary embolism include smoking, obesity and surgery. PE kills more people than breast cancer, AIDS, and traffic accidents combined each year. You can prevent blood clots with an IVC filter implanted in the inferior vena cava. The filter presumably catches clots to prevent pulmonary emboli (blockage of an artery in the lungs). However, IVC filter blood clot risks usually increase over time.
In fact, IVC filters left in long-term lead to more blood clots. A study published in the Journal of the American College of Cardiology confirms that leaving an IVC filter in raises dangerous blood clot risks. In other words, the very thing designed to prevent blood clots could actually cause them.
IVC Filter Blood Clot Dangers
The problem with IVC filters, is that they can fracture and migrate to other areas of the body and often do. Migration can occur to another part of the inferior vena cava, to the heart, or to the pulmonary outflow tract. Once the device migrates to the heart valves, right ventricle, or pulmonary outflow tract, removing it can be difficult or impossible. Migration often requires surgery, and sometimes, can result in death.
But migration is just one IVC filter concern. Filters can also fracture and damage internal organs. They can perforate the inferior vena cava wall, cause infection, and increase risk for pulmonary embolism. Ironically, that’s the very condition they should prevent.
Why Are Surgeons Still Placing IVC Filters?
According to the Mayo Clinic, only patients who don’t respond to blood thinners are good IVC filter candidates. Even then, IVC filters should remain a treatment of last resort. Since they’re not treated as such now, patients are suffering from unnecessary PE side effects.
The United States Food and Drug Administration received 921 adverse event reports about IVC filters from 2005-2010. Here’s how those reported injuries break down:
- 328 due to device migration
- 146 due to involved embolizations (detachment of device components)
- 70 due to perforation of the IVC
- 56 due to filter fracture
Doctors increasingly recommend IVC filters over anticoagulants. Though the FDA hasn’t released IVC filter adverse event reports since 2010, manufacturers make the same devices. In other words, there are thousands of consumers walking around with significant injuries—and some may not even know it.
IVC Filter Blood Clot Risks Noted In FDA Warnings
Since then, the FDA warned that retrievable IVC filters shouldn’t remain implanted permanently. The agency acknowledged that surgeons don’t always remove IVC filters once the patient’s risk for PE subsides. They recommend removing the filter as soon as PE risks abate. The FDA encourages doctors to discuss IVC filter removal benefits with patients. Essentially, they agree with the 2016 IVC filter blood clot study. Leaving an IVC filter in creates additional health risks the patient didn’t have before implantation.
The study states, “In absence of a congenital anomaly, the most common cause of IVC thrombosis is the presence of an unretrieved IVC filter.”
Evidently, IVC filters can harm patients already at increased risk for blood clots. While patients can avoid this risk by promptly removing the filter after the pulmonary embolism risk subsides, most do not. According to the 2016 IVC filter blood clot study, an increasing number of patients are developing PE from IVC filter implantation, because there is a substantial increase in the number of filters being placed in the United States and very low filter retrieval rates.
The study said if left untreated, IVC thrombosis patients may suffer additional complications. These include post-thrombotic syndrome, venous claudication, pulmonary embolism, and venous ulceration. “Given the significant morbidity associated with IVC filter thrombosis,” it states, “removal of these filters as soon as possible should be planned from the outset.”
Additional Evidence & IVC Filter Blood Clot Complications
A 2013 study states that the use of these filters combined with the low rates of retrieval, results in “suboptimal outcomes,” including mechanical filter failure, and high rates of venous thromboembolism (VTE). They set the stage for the dangers of PE as well, estimating that PE leads to more than 200,000 deaths annually in the United States, and that, “Despite a lack of randomized controlled trials demonstrating long-term safety and efficacy, IVC filter insertion continues to increase each year.”
The FDA issued a 2014 drug safety communication stating IVC filters should be removed when they’re no longer needed. Ideally, 29 to 54 days after implementation. They also required major device manufacturers to collect clinical data about malfunctions to conduct further studies.
Finally, (though this is by no means a comprehensive list), an editorial in JAMA Internal Medicine discusses IVC filter safety. Researchers note that though the devices “should” work to prevent PE, the results have, “never been validated by empirical studies.” The subheading to the article reads, “How could a medical device be so well accepted without any evidence of efficacy?”
What Patients Who Received an IVC Filter Can Do
Patients who have not received an IVC filter but may need one should actively voice their concerns to their physician. If you are unable to take standard blood-thinning medications or the medications are ineffective per your condition, they may be necessary. However, your doctor should monitor the IVC filter carefully and remove it once your PE risk subsides. Ask your doctor to remove it as soon as possible.
Patients whose IVC filter migrated, fractured, perforated, etc. and caused life-threatening complications have options for compensation. Lawsuits are currently underway against drug-manufacturing giants who created faulty IVC filters.
If you or your loved one suffered an IVC filter injury, you may be eligible for financial compensation. Learn more about the IVC filter lawsuit and get a free evaluation today to see if you may qualify.