A relatively new treatment for prevention of pulmonary embolism (PE) involves the use of Inferior Vena Cava (IVC) Filters. These small cone-shaped devices are designed to catch any blood clots (embolisms) that break loose from deep veins and then travel up to the heart and lungs. There have been very few studies so far, and just one controlled trial. Retrievable IVC Filters were first approved in 2003 by the FDA. Warnings were issued by the FDA in 2010, and the first lawsuits were filed in 2012; several remain pending in federal and state courts.
IVC Filters are extremely small metal devices that can be inserted into a vein using a thin catheter. The device has an expandable series of thin metal wires, each with a claw-type ending that will attach the device to the target area, holding it in place. It acts like a tiny cage that allows blood to pass through it, but it can catch any blood clots that also come through that area. Although some are permanent, most IVC Filters are designed to be retrievable once the imminent danger of clotting is over.
The IVC Filter is normally placed into the largest vein in the body, the inferior vena cava. This vessel transports de-oxygenated blood to the right atrium of the heart and also to the lungs. The blood comes up from a person’s lower extremities; any clots formed there may break off and be included in the blood flow upwards. Without this device, a blood clot could continue on to the lungs or heart and cause serious problems, including death of the patient. The device does have side effects and risks to consider before opting for this remedy.
Conditions Treated with IVC Filter
IVC Filter use is recommended for patients who cannot take blood thinning medications, but are prone to recurrent venous thromboembolism (VTE). VTE is caused by blood clots and results in deep vein thrombosis (DVT) or pulmonary embolism (PE); it can be fatal. If a patient cannot tolerate medicines like Warfarin or Heparin, which are anticoagulants, an IVC Filter may be used. Blood-thinning medications are often prescribed following surgery or trauma. Some people are unable to take anticoagulants to prevent blood clots. This is another option that could be used instead of those medications to combat the blood clotting problem.
It is estimated that between 300,000 and 900,000 Americas are affected by VTE each year and 60,000 and 100,000 of those will die from VTE. It generally occurs during or shortly after a hospital stay or surgery.
IVC Side Effects
Side effects from IVC Filter use include problems that occur when the device migrates away from its intended location. There could be problems with the device itself, such as filter fracture, or filter embolization. In some cases, there has been perforation of the vena cava, insertion-site or vena cava thrombosis and other thrombotic complications. Failure can also result in recurrent DVT or PE. Death has occurred in about 4% of failure cases.
If problems result from device failure, fracture or destruction, removal can be attempted. In the worst cases, fragments of the device shatter and are transported to other areas of the body, including the heart. This could require open heart surgery for removal, or it could become a fatal event. Some of the IVC Filters use a type of metal that cannot be subjected to an MRI; most are made of non-ferromagnetic materials that do not pose a problem if an MRI is needed.
IVC Filter Risks
As with any surgical procedure, there are risks involved with use of IVC Filters. To date, there have been no long-term studies that define overall complications that occur with IVC Filter use. Since these devices are intended to offer a solution to patients who cannot use anticoagulant medicines to stop blood clot formation, there will be blood-related risks.
If a filter becomes plugged with clots, it may no longer function and even create unique problems from that blockage. The filters are very thin when deployed, and in some cases, small pieces or even an entire part have become detached and then traveled to other body parts. There are reports of perforation in the duodenum or small-bowel regions, causing severe diarrhea or weight loss. The worst case scenario is when metal fragments get lodged in the heart or lung and then require surgical removal. Open heart surgery is a possibility when this happens, and that has its own set of risks.
Other potential risks include allergic reactions to substances used in the procedure, bleeding, and vein damage due to perforation during the procedure. If there is any type of perforation, emergency repair would need to be done. In rare cases, the IVC Filter has caused clot formation. In other cases, the filter itself shifted position after surgery and then required repositioning.
The procedure is supposed to allow capture of blood clots, and it does reduce risk of this event, but some clots could still bypass the IVC Filter and result in a pulmonary embolism. Other injuries occur at the site where the catheter was inserted into the neck or groin area.
Persons who have had an IVC Filter inserted should watch for certain serious symptoms. If you have any of these symptoms, contact your doctor or health provider immediately:
- Chest pain
- Numbness or pain in arm or leg
- Shortness of breath
- Leg becomes cold and turns bluish
- Bleeding, swelling or excessive bruising at the site where the catheter was inserted
IVC Filter Lawsuits
The first of many lawsuits was filed in 2012, in California and Pennsylvania courts. Other lawsuits in Indiana were consolidated into a Multidistrict Litigation lawsuit in 2014. Several manufacturers are the defendants, including Cook and Bard. Other lawsuits are still pending in state and federal courts. The FDA issued warnings about retrievable filters in 2010 and 2014. Their recent update recommends removal of the devices between 29 and 54 days following implantation. Lawsuits that have been filed claim that IVC Filters were the cause of personal harm and death.
If you have suffered complications or a loved one has died following implant of an IVC Filter, contact our Personal Injury Attorney to determine eligibility to join a class-action lawsuit or to file an individual action against the filter manufacturer. Time limits may apply; your attorney can advise you of the best course of legal action to gain compensation and best results.