In recent litigation news, the FDA warned medical care providers that inferior vena cava (IVC) filters, could cause injuries due to the device breaking down. The FDA’s warning focused on long-term use of the temporary models, which are meant to helps prevent pulmonary embolism in patients.

The controversy over IVC filters started in 2010, when the FDA issued a public safety announcement of IVC filters, stating that it had received 921 injury reports since 2005. The FDA went on to further say that they received 328 injury reports of IVC filter migration, with 146 involved IVC filter components detaching, 70 reports indicating IVC filter perforation, and 56 injury reports involving IVC filter fracture.

This caused the agency to begin an evaluation of IVC filters to determine what the risks and benefits of the device are. Furthermore, the agency recommended that IVC filters be removed from patients between 29 to 54 days, after the pulmonary embolism is resolved and after implantation. According to the FDA, the most common complications associated with IVC filters include:

• IVC Thrombosis
• Deep Vein Thrombosis (DVT)
• Access Site Thrombosis
• Filter Migration
• Caval Penetration
• IVC Filter Fracture

These IVC filter complications are unfortunate because the devices are designed to help prevent blood clots from moving from the legs or pelvis to the heart or lungs. The blood clots trapped by the IVC filters stay in the device until they dissolve naturally and should be removed after the clot is resolved. However, there are certain IVC filter models that are designed for permanent placement. These cage-like metal devices are implanted directly in the veins of the patients, which allows for direct interference of the blood clot.

Overview of IVC Filter Complications

At the time the IVC filter was introduced in 1979, it was considered a great medical innovation, as it allowed for direct intervention of potential cardiac attacks. By 2012, there have been 259,000 IVC filter implantations. Some medical experts state that IVC filters may work better than other treatment options as it does allow the blood clot to dissolve naturally.

The inferior vena cava is the largest vein in the patient’s body, located below the kidneys and is responsible for dissolving blood clots by removing deoxygenated blood clots from the lower legs to the heart’s right atrium and the lungs. The IVC filters are implanted directly by a interventional cardiologist or interventional radiologist into the inferior vena cava through a small incision in the neck or groin, where the metal wires capture blood clots before they reach the lungs.

Unfortunately, these devices have been alleged to cause dangerous complications due to either breaking apart or perforating. As mentioned before, there are permanent and temporary IVC filters; however, experts state that the temporary filters should be removed soon after the blood clot is resolved because they have been shown to break apart.

Experts believe this is due to the fact that temporary IVC filters may not be as well made as their permanent models and therefore not built to last. However, none of the manufacturing companies mentioned these complications on the device labels, nor did they provide special instructions to surgeons.

Due to these IVC filter complications, a number of patients have chosen to pursue legal action against these manufacturing companies. Some of the IVC filter devices in question include: ALN Implants Chirurgicaux, Bard Peripheral Vascular, B Braun Medical, Boston Scientific, Cook Medical, Cordis, Rafael Medical Technologies, and Rex Medical.