27 Fatalities And Other Complications

Part one of the investigative series revealed that 27 individuals died from IVC filter problems in the last decade. In addition, there were 300 reports of other complications. The device in question, C.R. Bard’s Recovery filter, is implanted in the inferior vena cava vein to stop blood clots.

One of the thousands of people implanted with IVC filters, a 45-year-old woman named Dodi Froehlich, nearly died when a part of the IVC filter broke off and moved to her heart. She had the device implanted after a car accident that made her more susceptible to clotting, NBC reports. If this will lead to an unfortunate outcome, you can talk to Houston wrongful death lawyer if you have lost your loved one due to someone’s else negligence.

Another woman, 55-year-old Gloria Adams, died after a powerful blood clot propelled the entire spider-like IVC device to her heart. The filter was meant to protect her after a brain aneurysm.

One of the main components of the investigation is an attempt to find out if C.R. Bard knew about the device failures and health risks.

Hiding Study Results To Sell Products

Patients began to speak out about complications. Instead of issuing a recall, C.R. Bard hired a public relations firm for damage control. Simultaneously, the device manufacturer privately researched IVC filter complications.

The study showed that the IVC filter Recovery model was associated with a greater risk of fracture, migration and early death. C.R. Bard kept the results hidden and continued to sell thousands of rebranded filters, NBC reports.

Despite initial difficulties with FDA clearance and insufficient clinical trials, the company claims that the product meet federal safety standards. Representatives from C.R. Bard issued a statement that IVC filters offer “significant benefits to patients.”

Kay Fuller, a regulatory affairs specialist hired by Bard to help get FDA approval the second time around, noticed safety issues and reported them to the FDA. NBC investigators discovered that Fuller’s signature on the FDA application appears to be forged, which she confirmed in an interview with the news organization.

NBC reports that more than 20,000 people are implanted with IVC filters. Individuals who experienced complications may be entitled to a lawsuit.

Request a free case evaluation to learn more about compensation opportunities.

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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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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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A study published in the Journal of the American Medical Association found that nearly 20 percent of IVC filters were unsuccessfully removed.

Retrievable inferior vena cava (IVC) filters are marketed as a temporary treatment for pulmonary embolism.

The medical device, meant to be removed when a patient’s risk has subsided, is an attempt to avoid potential long-term problems caused by permanent filters.

However, researchers have discovered that IVC filters are not always removable. Recent data illustrates that unretrieved IVC filters may come with a variety of additional complications.

Details of the Study

Researchers analyzed the medical records of 952 patients with IVC filters.
Image: IRMC

In April 2013, the Journal of the American Medical Association published a study that tested the safety of retrievable vena cava filters. The research focused on making conclusions about “complications, follow-up data, date of IVC filter retrieval, and use of anticoagulant therapy.”

Boston Medical Center began reviewing IVC filter use between August 1, 2003, and February 28, 2011. The study included 978 patients total, but 26 were excluded due to incomplete medical records. Overall, researchers analyzed 952 medical records.

Discovering Complications

Patients experiencing complications with IVC filters may need to undergo prolonged treatment in a hospital setting.
Image: Medical News Today

Of the 679 retrievable IVC filters that were placed, 58 were successfully removed. However, nearly 20 percent of attempts were unsuccessful. Researchers concluded that “unretrieved removable IVC filters may carry significant long-term risks.”

Additionally, the team cited 10 serious filter-related complications stemming from the lack of removal. These painful complexities required patients to be admitted to the hospital, sometimes for an extended period of time.

Examples of these issues  included a 33-year-old man with a fractured IVC filter that lodged in a pulmonary artery and a 56-year-old man who experienced filter perforation that caused abdominal bleeding.

“The Food and Drug Administration recommends that IVC filters should be removed as soon as the risk of PE has subsided,” according to the study.

A systematic review of 37 studies confirmed an increased rate of complications associated with filters left in place for longer than 30 days, including recurrent deep vein thrombosis, vena cava thrombosis, organ penetration, migration, and strut fracture.

Patients who experienced complications with IVC filters should complete a no-obligation survey to find out if they are eligible for legal compensation.

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The FDA began receiving injury reports related to IVC filters in 2005, which prompted the regulatory agency to evaluate the overall safety of the devices.

An inferior vena cava filter, also known as an IVC filter, is a medical device implanted into an essential vein that carries blood to the heart.  The devices are used to prevent life-threatening blood clots from traveling through the body and blocking the lungs from functioning properly.

The growing popularity of IVC filters has come with a variety of complications, including device migration, filter fracture, movement of the filter or its pieces to the heart or lungs, perforation of the vessel, and a challenging removal.

After receiving hundreds of reports of these complications, the FDA has issued a safety announcement about the device and continues to assess the adverse effects it may cause.

All About IVC Filters

The inferior vena cava is a large vein that brings blood from the lower portion of the body to the right chamber of the heart.
Image: My School Lights

The inferior vena cava is a vein that transports blood from the lower body to the heart. The small cage-like device is implanted into the major blood vessel to stop blood clots from traveling to the lungs.

The device is often recommended for patients with an increased risk of a blood clot moving toward the lungs, a condition known as pulmonary embolism (PE).

In many cases, these patients are unable to utilize pharmaceutical anticoagulant medications. While the some of the “retrievable” devices may be removed, some IVC filters are marketed as a permanent way to prevent blood clots from migrating to major organs.

The FDA Raises Concerns Once Again

In some cases, it may be very difficult to retrieve IVC filters from the body.
Image: Phase One Medical

In 2010, the FDA released an initial communication informing the public about the potential dangers of IVC filters. The regulatory body cited the growing popularity of these devices, which increased from 2,000 IVC filters used in 1979 to almost 167,000 filters in 2007.

The FDA refers to a number of difficulties that may arise from IVC filter implantation. The organization is working to analyze these occurrences in order to distinguish the frequency of the complications.

“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforations of the IVC, and 56 involved filter fracture,” according to the FDA’s report.

In 2014, the FDA released an updated communication on the subject of IVC filters. However, the organization will continue to collect additional data on both retrievable and permanent IVC filters.

What’s The Takeaway?

The FDA urges physicians to closely supervise treatment with IVC filters and measure the risk/benefit profile of each patient.
Image: Health Tap

While an IVC filter can be very beneficial, it can also be dangerous. Doctors must closely monitor all patients using the device by following up to check the status of each individual.

The FDA recommends that physicians weigh the benefits and the risks of IVC filters. If a patient’s risk of pulmonary embolism has diminished, doctors should consider removing the device in order to prevent problems in the future.

The FDA urges doctors and patients to be aware of issues with “device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device” and long-term risks such as “lower limb deep vein thrombosis and IVC occlusion.”

However, there are many patients who have already experienced complications from IVC filters. Complete a free, no-obligation case evaluation now to see if you qualify for compensation.

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