On August 9, 2010, the U.S. Food and Drug Administration (FDA) issued a safety communication about the risks of adverse events concerning retrievable Inferior Vena Cava or IVC filters.
In the communication, FDA recommended physicians consider removing the IVC filter “as soon as protection from [pulmonary embolism] is no longer needed.” The FDA further recommended ongoing follow-up and referral for IVC filter removal when “feasible” and “clinically indicated.”
The FDA issued a second safety communication on May 6, 2014, repeating the prior guidance and updating studies and market research on retrievable IVC filters. The second safety communication stated:
The mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.
Although the results of the decision analysis provide important insight for retrievable IVC filters, the FDA is requiring the collection of additional clinical data for currently marketed IVC filters in the United States. The studies will address safety questions that remain unanswered for both permanent and retrievable filters.
As explained below, patients allege retrievable IVC filters migrate, meaning they move within the body. Patients further allege IVC filters may tilt or shift, causing the IVC filter to fracture or explode in the body, preventing removal and causing filter pieces to migrate within the body, including traveling to the heart and lungs.
Plaintiffs also allege defective IVC filters have punctured adjacent organs and blood vessels. Hundreds of lawsuits have been filed against IVC filter manufacturers.
Inferior Vena Cava or IVC Filter
An inferior vena cava or IVC filter is a small metal device that prevents blood clots from getting stuck in your lungs. IVC filters look like small wire cages. These metal devices are inserted into your inferior vena cava, which is the vein that carries blood from your lower body to your heart.
IVC filters were first introduced in 1979. To date, hundreds of thousands of IVC filters have been implanted in patients.
IVC Filters and Blood Clots
IVC filters are designed to catch blood clots before they move into a patient’s heart, lungs, or other body areas. Each year, around 200,000 blood clot filters are implanted to prevent pulmonary embolism.
Surgeons will implant IVC filters in patients with pulmonary embolism or deep vein thrombosis who should not be given drugs to stop blood clots. Thus patients who cannot take blood thinners, but are at risk for blood clots, may instead be implanted with an IVC filter.
IVC Filter Lawsuits
Hundreds of cases have been filed by patients who allege they were injured by defective IVC filters. Many cases currently are on file in San Francisco, and more than a hundred cases are pending in Indianapolis.
Patients have alleged multiple claims against IVC filter manufacturers concerning defective retrievable IVC filters, including design defects, manufacturing defects, consumer fraud, misrepresentation, strict liability, failure to warn, and wrongful death.
IVC Filter Complications and Side Effects
Patients allege IVC filters migrate, meaning they move within the body. They also allege the IVC filter tilts or shifts, resulting in the filter fracturing or exploding in the body, preventing removal and causing filter pieces to migrate within the body, including traveling to the heart and lungs. Plaintiffs also allege IVC filters will puncture adjacent organs and blood vessels.
Safety Concerns With IVC Filters
The Food & Drug Administration has received numerous reports about problems with retrievable IVC filters.
The problems include IVC filter fracturing, the filter moving or migrating in the body after implantation, pieces of the IVC filter moving into the patient’s heart or lungs, the IVC filter puncturing human tissues, and complications that arise when attempting to extract a retrievable IVC filter.
The FDA explains:
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.
On August 9, 2010, the FDA issued a safety communication stating IVC filters “are not always removed,” and known long-term IVC filter risks include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization, and IVC perforation.
IVC Filter Manufacturers
IVC filter manufacturers include:
- Bard G2, G2X, G2 Express, Eclipse, and Recovery
- Cook Medical Gunther Tulip, and Celect
- Johnson & Johnson Cordis, OptEase, and TrapEase
- Boston Scientific Greenfield SS and Ti-Permanent
- B. Braun Medical Convertible, Vena Tech, and LP
- Rex Medical Option
- Rafael Medical SafeFlo
Retrievable IVC filters are usually made of metals that are non-magnetic. For example, Bard’s IVC filter is made of Nitinol or nickel-titanium alloy. Cook’s IVC filters are made of Conichrome or cobalt chromium-nickel molybdenum iron alloy.
IVC Filter Placement
An IVC filter generally will be placed just below your kidneys using a catheter to deploy the IVC filter. A vascular surgeon or cardiologist will administer a local anesthetic, numb the insertion site, and insert a catheter into your groin via a small incision into your large vein.
The catheter is used under x-rays to guide the placement of the IVC filter in your inferior vena cava below your kidneys. The filter is then deployed. After deployment, the catheter is removed and your groin incision is bandaged.
IVC Filter Removal
Similar to filter insertion, removing your IVC filter is done under an x-ray and using a catheter with a snare. The catheter snare hooks onto the end of your IVC filter, which is then covered in a sheath and then removed from your body.
Some IVC filters are placed permanently. Optionally retrievable IVC filters are usually placed in patients with a high risk of pulmonary embolism and are later removed when the risk decreases.
Typically, a retrievable IVC filter can be removed if done within several months of insertion. The decision to remove an IVC filter will be based on the patient’s particular risk factors, including whether they can take blood thinners and the length of time they are at risk for blood clots.
Generally, the longer a retrievable IVC filter has been in place, the more difficult it becomes to remove. The most common reasons an IVC filter cannot be removed are it becomes lodged in the wall of the inferior vena cava or the filter becomes filled with large blood clots.
IVC Filter Legal Claims
You may have a claim if you or a family member has had any problems with your IVC filter. More serious IVC filter problems include filter moving or migration, filter tilting, and filter fracture.
Especially dangerous is an IVC filter migrating to the heart or fractured pieces of the filter migrating to your heart or lungs.
If an IVC filter injured you or a family member, please fill out our form for a free case review.