Blood clot filters are implanted in the inferior vena cava (IVC) and used for the prevention of pulmonary embolism. A recent analysis of national data, published in the National Library of Medicine, shows that blood clot filters may come with serious side effects.

Are Blood Clot Filters On The Rise?

IVC filters were introduced in the 1960s and approved by the Food and Drug Administration (FDA) through the agency’s 501(k) expedited process.  As the population ages, blood clot filters placement has increased as an alternative to anticoagulant medications. Trends illustrate more patients receive temporary, rather than permanent, IVC filters.

National data from Medicare and a National Discharge Survey indicates blood clot filter placement has markedly increased in the last two decades.

Data shows the placement of inferior vena cava (IVC) filters have been expanding, despite a lack of clear directing evidence. When IVC filters were approved, there was minimal data about blood clot filters, along with inconsistent recommendations across societies about how blood clot filters should be used.

Study Data On Blood Clot Filters 

Researchers examined how well blood clot filters work, measuring complication rates and national trends. The study data comes from a 9-year period at Einstein Medical Center in Philadelphia, PA. The researchers also assessed national trends using the Nationwide Inpatient Sample. 

The patients had an IVC filter implanted between 2003 and 2013. They were likely to elderly and high-risk for bleeding complications when using blood thinners.

Though temporary filters are becoming increasingly popular, the researchers found that only 7 percent of filters designed for retrieval were successfully removed. Researchers discovered many patients qualified for filter removal after receiving an IVC filter, but hospitals discharged patients with the device still in place. They suspect the reasoning could be “an increased reimbursement rates when filters are retrieved in an outpatient setting and an under-appreciation of the potential harms of leaving filters in place for extended periods.”

Although temporary IVCFs are becoming increasingly popular, their timely removal remains a significant challenge.

In 2010, the FDA issued a safety warning to inform physicians to remove IVC filters as soon as the risk of pulmonary embolism had subsided. The filters, though minimally invasive, have been associated with”clear evidence for filter-related complications even several years after placement.”

Some patients may experience complications early on, while others develop no symptoms. Potential complications, though varied, include: 

• Access site hematoma
• IVC thrombosis
• IVC perforation
• Air embolism
• Pneumothorax
• Filter migration
• Filter fracture

More temporary IVC filters are placed for prior falls and bleeding complications. In order to avoid exposing patients to unnecessary risks with little benefits, researchers acknowledge that filters should be removed as soon as possible. 

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A Mississippi man filed a lawsuit to obtain monetary awards as compensation for pain and suffering caused by an irremovable IVC filter medical device.

Mississippi man Alec Caldwell had a blood clot filter implanted in his inferior vena cava. It seemed the device was working well until he started to experience severe pain.

Caldwell attempted to have his filter taken out and discovered that the device was not only impossible to remove, but also had rotated and damaged his essential IVC vein.

He has since taken legal action and filed a product liability and personal injury lawsuit against the device manufacturer, who allegedly knew about the risk of perforation and difficulties with removal.

Complications With Perforation And Removal

IVC filters may shift and become tilted, situating the device in a position that would lead to vein perforation and extended medical problems.
Image: Research Gate

Caldwell had the Eclipse model IVC filter implanted in his body on Sept. 29, 2010. It was meant to stop blood clots from traveling to the lungs, which could cause pulmonary embolism to occur.

Bard, the makers of the IVC filter, allegedly knew about the device’s risks and didn’t inform the consumer. The lawsuit states that Bard was aware of the product’s “serious design and manufacturing flaws causing it to have inadequate stability and structural integrity, as well as a high propensity to perforate the vena cava.”

On Dec. 9, Caldwell decided to file a lawsuit against the manufacturer of the medical device that caused him serious pain and suffering.

In the lawsuit, prosecutors argue on Caldwell’s behalf, claiming that he “suffered and will continue to suffer significant medical expenses, pain, suffering, emotional distress, loss of enjoyment of life, psychological trauma, anxiety, hedonic damages, lost wages, loss of earning capacity, the need for medical monitoring of the Eclipse filter, and any other form of damages under the law of the subject forum.”

The prosecutor intends to hold Bard liable for manufacturing, information and design defects, negligence due to failure to recall products and warn consumers, breach of warranty, fraudulent misrepresentation and concealment. The goal is to provide Caldwell with enough financial restitution to cover his medical bills, lost income and more.

If you experienced difficulties removing your IVC filter, you may also be entitled to compensation.

Take the next step and request a free case evaluation to learn about your legal rights.

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A Missouri woman is suing the manufacturer of an IVC filter medical device that fractured, migrated to her back and caused severe pain.

A St. Louis woman began to experience chronic back pain, but she couldn’t find the source. Doctors traced it to a piece of the Bard G2 filter system that had been implanted in her body, broke off and  traveled to her back.

On Nov. 24, 2015, she filed a lawsuit against Bard in the Eastern District of Missouri. She’s taking legal action to gain compensation that will help cover extensive medical expenses caused by complications with the IVC filter.

IVC Filters May Fracture And Migrate

The Bard G2 IVC filter has been linked to increased risk of fracture and migration.
Image: West JEM

In Sept. 2008, the Missouri woman had an IVC filter implanted in her body to protect against pulmonary embolism (PE).

One of the filter’s legs broke off and traveled throughout her body, becoming stuck in her back. After months of pain, she finally discovered the problem and decided to take action.

The Bard G2 filter system was approved through the 510(k) approval process and never underwent safety trials. In 2010, researchers conducted a study and discovered that 16 percent of Bard G2 filters fractured.

In the lawsuit, the woman claimed that she wasn’t properly warned about the high risk of fracture and migration associated with IVC filters. She’s suing for negligence, fraud, failure to warn, design defects and breach of warranties.

In addition to gaining assistance with her mounting medical expenses, the Missouri woman is suing the filter manufacturer in order to get compensation for her pain and suffering.

If you or a loved one experienced complications from an IVC filter, you may be eligible for legal help and compensation. Request a free, no-obligation case evaluation for more information.

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Although inferior vena cava filters can help prevent blood clots from traveling through the body, the devices are associated with a variety of complications.

Blood clots serve an important purpose. They’re able to stop bleeding and prevent excessive spillage after a cut or injury.

Unfortunately, blood clots can also form when they aren’t needed. Unnecessary clotting has been linked to heart attack, stroke and other serious medical problems.

Inferior vena cava (IVC) filters are meant to keep blood clots from traveling through the body. However, research shows that these devices may be dangerous.

The Potential For Complications

IVC filters have been linked to deep vein thrombosis, a condition that causes painful swelling of the leg.
Image: Seconds Count

IVC filters are specifically recommended for patients with a high risk of pulmonary embolism (PE), but many health professionals claim the device lacks an established safety profile. Although IVC filters decrease the risk of PE, they may cause a condition called deep vein thrombosis (DVT).

The National Center for Biotechnology Information (NCBI) published a study from the University of Chicago Hospitals that divided IVC filter complications into three categories: “procedural complications, including those related to both venous access and filter deployment; delayed complications, including filter fracture, migration, IVC thrombosis, and recurrent PE; and complications of filter retrieval after implantation of temporary IVC filters.”

According to NCBI, “certain complications are beyond the control of physicians.” For this reason, it’ is important to be aware of the possible risks associated with IVC filters.

Procedural Complications

• Venous access issues include bleeding, hematoma, inadvertent arterial puncture, and infection
• Malposition
• Defective filter deployment

Delayed Complications

• Filter migration
• Filter fracture
• Vein/organ perforation
• Infection
• Deep vein thrombosis
• Difficult or impossible retrieval

IVC filters are marketed as a permanent or temporary alternative to anticoagulant treatment. However, IVC filters are only recommended for use in patients unresponsive to anticoagulants.

Many patients will have the devices implanted regardless. If you experienced complications with your IVC filter, you may be entitled to compensation.

Click here to take a short survey and learn more about compensation eligibility.

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