inferior vena cava filter – Citizens Report https://citizensreport.org a digital channel commited to health & medical rights. Wed, 17 Jan 2024 09:06:12 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.24 https://citizensreport.org/wp-content/uploads/2016/12/cropped-cr-icon-1-32x32.png inferior vena cava filter – Citizens Report https://citizensreport.org 32 32 Mississippi Man Files Lawsuit Over Irremovable IVC Filter https://citizensreport.org/2016/02/18/irremovable-ivc-filter-lawsuit/ https://citizensreport.org/2016/02/18/irremovable-ivc-filter-lawsuit/#respond Thu, 18 Feb 2016 20:26:33 +0000 http://www.citizensreport.org/?p=10479 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 […]

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Inferior Vena Cava Filters Are Difficult To Remove And People Can File Lawsuits Against The Medical Device Manufacturer

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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FDA Is Currently Evaluating The Safety Of IVC Filters https://citizensreport.org/2015/12/21/fda-questions-ivc-filter-safety/ https://citizensreport.org/2015/12/21/fda-questions-ivc-filter-safety/#respond Mon, 21 Dec 2015 17:43:39 +0000 http://www.citizensreport.org/?p=9909 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 […]

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Food and Drug Administration Analyzes The Removal Of Inferior Vena Cava Filters

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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