Hello, I’m attorney Rosemarie Bogdan and I’d like to tell you about a medical device called an IVC Filter.
An IVC Filter is a spider-like wire cage that’s implanted in the major vein that carries blood from the lower body into the heart. The IVC filter’s purpose is to prevent blood clots from entering the heart, lungs or brain. It is supposed to catch the clots while they are still in the bloodstream and allow them to break down over time.
So what are the side effects, problems and risks of IVC filters?
They can tilt, migrate through the bloodstream and even fracture. If this happens, the whole device or pieces of it can move through the blood, work their way through a vein wall and damage internal organs such as the heart or lungs.
Because of the dangers involved, the FDA issued a safety communication recommending when IVC filters should be removed. The FDA has suggested that if a patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor the removal of the IVC filter between 29 and 54 days after implantation.
If you or your loved one has an IVC filter we can help you determine the type of IVC filter you have, and whether you may have a compensable claim. Use the chat feature on this website to chat 24/7 or call us now at 1800LAW1010 for a free, no obligation case evaluation.
IVC (Inferior Vena Cava) is a major vein that carries deoxygenated blood from the lower body into the right atrium of the heart muscle. An IVC Filter (also known as a vena cava filter or blood clot filter) is a small wire cage-like device that is implanted in the major blood vessel between the lower half of the body and the heart. Its purpose is to prevent potentially life-threatening blood clots from entering the heart, lungs or brain by catching the clots in the bloodstream and allowing them to dissipate over time. The filters are implanted in patients who are frequently at high risk of pulmonary embolism (PE) but whose blood clots cannot be controlled with blood thinners and other anticoagulant medications. IVC Filters have been around since the late 1960s and were originally designed as permanent, non-removable implants. In 2003 and 2004, the first permanent IVC Filters with the option to retrieve entered the marketplace.
There have been numerous claims of injuries due to permanent IVC Filters with the option to retrieve. They include internal bleeding, pulmonary embolism stroke and in the most severe cases, death. In some patients, the IVC device fell out of place or fractured. The metal filter, or pieces of it, migrated through the vascular system, working its way through a vein wall and puncturing an internal organ. Over time, the U.S. Food and Drug Administration has received hundreds of adverse reports regarding severe complications associated with these devices.
- The filter could move, migrate or change position and become stuck in a place where it is not designed to be. This could cause it to become ineffective or inflict damage to internal organs.
- The filter could perforate or erode into the inferior vena cava, causing damage to this vein. It could also protrude and damage internal organs.
- Parts of the filter can break off, travel in the bloodstream and severely damage the heart or lungs.
- The filter may become clogged with clots which could block the flow of blood from the lower body into the heart.
- Damage to the heart, lungs, inferior vena cava, or other internal organs.
- A doctor may be unable to safely remove the IVC Filter.
In 2010, the FDA recommended that if a patient has an permanent IVC filter with the option to retrieve, the patient’s individual risk/benefit profile should be examined and the filter should be removed when feasible and clinically indicated.
A second FDA warning issued in 2014 recommends that permanent IVC Filters with the option to retrieve be removed as soon as the protection from pulmonary embolism is no longer needed. Using publicly available data from medical literature, the FDA assessed whether there is a time period during which the risk of having an IVC Filter in place is expected to outweigh the benefits. A mathematical model for an appropriate timeframe was then developed. The decision analysis, published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013, suggested that if the patient’s risk for pulmonary embolism has passed, removal of the IVC Filter should occur between 29 and 54 days after implantation.
In light of these FDA warnings, patients are consulting with their physicians to make sure the device has not dislodged or fractured, and to determine if and when it should be removed.
Patients with permanent IVC Filters with the option to retrieve are now reaching out to attorneys for help regarding their injuries. These IVC Filter lawsuits allege that manufacturers C.R. Bard, Cook Medical and others, failed to warn patients and physicians of the increased risks associated with their products. They claim negligence, design defects, manufacturing defects, breach of implied warranty and misrepresentation on the part of the companies and their subsidiaries.
Our IVC Filter attorneys are ready to help you with this type of case, and are available to assist you from our many offices throughout New York State and Vermont, including locations in: Schenectady, NY, Saratoga, NY, New York City, NY, Plattsburgh, NY, Albany, NY, Buffalo, NY, White Plains, NY, Rochester, NY, – as well as Manchester, VT and Burlington, VT. Our call centers are available day and night to help protect your rights.
If you or someone you know received a permanent IVC Filter with the option to retrieve implant, you may be eligible for financial compensation. Call us today at 1800LAW1010 (1.800.529.1010) to determine your eligibility and find out what legal action you may take regarding these defective products.