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 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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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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