IVC Filter
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6
May
2014
Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication
This safety communication updates FDA’s 2010 Initial Communication. The update provides information on recently published research and postmarket studies for these devices. There are no new safety concerns related to this update.
Summary of Problem and Scope: The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include 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. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.
Recommendations/Actions: The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.
The FDA encourages all physicians involved in the treatment and follow-up of patients receiving IVC filters to consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.
Recommendations/Actions: FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed.
- Resources:
People whom have been injured by usage of an IVC Filter do have legal options
Experienced IVC filter lawyers are currently reviewing potential claims across the country from patients and their family members. Plaintiffs may be entitled to compensation for medical expenses, lost income, lost future earning capacity, emotional pain and suffering, permanent disability, and (in the worst cases) funeral expenses.
You may not be able to continue working or taking care of your family, and may need to hire somebody to assist you. When a medical device manufacturer puts patients’ and well-being at risk, the American legal system has remedies available. These include:
- Mass Torts and Multi District Litigation: A mass tort is when a group of plaintiffs file their legal proceedings in a state court, while a multi district litigation (MDL) is held in a federal court.
- Class Action Lawsuit: In a class-action lawsuit, plaintiffs with similar injuries all combine into one single lawsuit.
- Individual lawsuits: In an individual lawsuit, the injured party sues the drug manufacturer directly both for the expenses that they have incurred as a result of their actions and for punitive damages.
Our firms work on a contingency basis which means you will not be asked to pay any money out of pocket.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
Common IVC Filter Side Effects
If an IVC filter fractures in a patient’s body the filter, or parts of it, can migrate causing internal injuries including:
- Perforation of the heart
- Perforation of the lungs
- Hemorrhagic pericardial effusion (blood around the heart) - See more at: http://www.aboutlawsuits.com/ivc-filter-12082/#sthash.rc8XdzLe.dpuf
- Cardiac tamponade (disruption of the heart caused by excess fluid) - See more at: http://www.aboutlawsuits.com/ivc-filter-12082/#sthash.rc8XdzLe.dpuf
- Ventricular tachycardia (accelerated heart beat)
- Puncturing of the vena cava
Consult your doctor:
In many cases, the problems require emergency treatment for the blood clot filter removal, which may result in open heart surgery in some cases. Through an IVC filter lawsuit, individuals who have experienced a fracture, failure or migration of their device may be able to obtain compensation from the manufacturer as a result of the allegedly negligent and defective design of these products.
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