An inferior vena cava filter (IVC filter) is a medical device that is surgically implanted into the inferior vena cava, the larger blood vessel that runs from the abdomen into the heart and returns blood from the lower half of the body.

The device functions by filtering out blood clots to prevent them from traveling to the heart and lungs.

However, many concerns have been raised about the safety of IVC filter removal, specifically that IVC filters can break off and migrate into the heart, lungs and other vital organs, leading to serious, potentially fatal injuries.

IVC Filter Removal Risks

Initially, IVC filters were developed for permanent placement. Today however, there are now many IVC filters designed for short-term use. Permanent IVC filters remain in the inferior vena cava. Retrievable IVC filters can be removed after the medical condition has improved.

Retrievable filters are designed to be removed, but removal can be technically challenging because the longer it is left in place, the more difficult it is to retrieve.

Although manufacturers have different recommendations about how long a filter should stay in, the retrievable filters should generally be removed four to six weeks after placement. If left longer, they may lead to vena cava filter complications by becoming too firmly attached to the inferior vena cava to be removed.

The FDA issued a warning on August 9, 2010, against leaving IVC filters in for extended periods of time, because they have a tendency to cause life-threatening complications.

Concerned about doctors not retrieving the IVC filters intended for short-term placement, the FDA warned implanting physicians and clinicians that IVC filters are for short-term use in patients at risk for pulmonary embolisms.

Doctors are to retrieve the the device through an IVC filter removal procedure once the patient’s risk subsides, to avoid exposing patients to IVC filter complications caused by fractured devices.

This government safety warning came after the Archives of Internal Medicine study conducted by Dr. William Nicholson at the York Hospital in Pennsylvania found a high prevalence of fracture and fragment embolisms with retrievable IVC filters.

IVC Filter Complications

Pulmonary embolisms (PE) are a severe and often fatal condition that occurs when a lower extremity thrombus embolizes to the lungs.

While anticoagulant medication is the first treatment of choice for PE, IVC filters may be implanted if anticoagulant use is unsuccessful. In addition to pulmonary embolism, there are several severe vena cava filter complications associated with medical devices:

• Fracture of the IVC filter
• Perforation, puncture or serious damage to the heart
• Damage to the lungs or vena cava
• Internal bleeding
• Cardiac or pericardial tamponade
• Ventricular tachycardia
• Lower limb DVT
• Hematoma or nerve injury at the puncture site
• Constant and severe pain in the heart, chest, or elsewhere
• Infection
• Death

IVC Filter Lawsuits

The FDA updated their 2010 safety communication in May 2014 regarding IVC filter removal complications.

The FDA has received more than 1,000 reports of serious adverse events related specifically to Bard IVC Filters.

Reports include 328 for device migration, 146 for embolizations (device component detachment), 70 for perforation of the IVC, 56 for filter fracture. Similar problems have been found with other IVC filters made by Cook Medical, Boston Scientific, B. Braun and others.

As such, more and more former recipients of IVC filters are coming forward with complaints of serious injuries from the implants and are filing legal claims against the makers of the allegedly defective medical devices, citing poor design and manufacturing as the reason for their injuries.

All of the lawsuits filed over vena cava filter complications from the Bard IVC filter complaints have been centralized before U.S. District Judge David G. Campbell in the U.S. District Court of Arizona; the Cook Celect IVC filter have been centralized before U.S. District Judge Richard L. Young in the U.S. District Court in the Southern District of Indiana.

If you or a loved one experienced serious complications after an IVC filter procedure or are seeking to have an IVC filter removal due to diagnosed problems with the device, you should contact an experienced attorney for to discuss your legal options. You may be entitled to compensation for your injuries or loss.