The Inferior Vena Cava Filter, or “IVC Filter,” is a medical device that’s surgically implanted in patients who are at risk for developing pulmonary embolism. In other words, the device is used to prevent blood clots. There are various types of filters; however, these devices can be divided into two main categories: “permanent,” and “retrievable.” As the name suggests, permanent IVC filters cannot be removed once surgically implanted in a patient. On the other hand, retrievable filters are designed with a hook which allow surgeons to extract the implanted device.
This article shares information on different types of IVC devices. Specifically, the article discusses why some filters are permanent, why some are retrievable, and most importantly, the potentially fatal dangers/complications associated with this device that have led to mass IVC filter lawsuits against certain manufacturers.
IVC Filter Types
As previously discussed, an Inferior Vena Cava Filter may either be permanent or retrievable depending on the design. Originally, many devices were designed as a permanent solution because manufacturers did not believe there was a high enough risk for complications/failure to justify the addition of a retrieval mechanism. After studies began to surface that vena cava filters significantly increased the risk of serious long term health complications, they started designing filters that were retrievable. Below is a list of major IVC Filter manufacturers along with specific problematic devices.
Günther Tulip – This is a retrievable filter manufactured by Cook that’s designed with 12 wires and 4 legs. The device has been used in the United States since 2003. The Gunther Tulip carries a very high risk of pieces breaking off and migrating into various parts of the body.
Celect – The Cook Celect and Celect Platinum are retrievable vena cava filters that carries a high risk of fracture, migration, and other potential serious consequences.
Bird’s Nest – Cook Medical produced another IVC device to prevent complications common in previous designs. The Cook Bird’s Nest IVC Filter was designed with strands of wires instead of legs to help prevent the filter from migrating or tilting. Despite these efforts, many complications such as device fracture have still occurred in patients.
C. R. Bard
G2 Express (G2X) – The G2X presents a high risk of fracture which also carries the risk of broken components from the device traveling to other parts of a patient’s body.
Denali® – In 2015, Bard issued a Class 2 Device Recall on Denali. The recall was due to a labeling error which excluded a warning to patients with “uncontrolled sepsis and patients with known hypersensitivity to nickel-titanium alloys” (U.S Food and Drug Administration, Class 2 Device Recall Bard Denali IVC Filter, 2015). Since this time, the instrument has been linked to other controversies and complications.
Other Bard Devices – Recovery, G2
TrapEase – The TrapEase Permanent Vena Cava Filter is a fairly large star-shaped filter that has been the subject of tremendous controversy as it carries an extremely high risk of fracture. In fact, a published medical study conducted in 2012, concluded that the TrapEase carries a 50% risk of fracture in patients.
OptEase – Unlike the previous TrapEase, the OptEase was designed by Cordis as a retrievable blood clot filter. Unfortunately, studies have shown that patients implanted with this device were exposed to an unnecessarily high risk of organ damage due to filter fracture, tilt, or migration.
IVC Filter Complications
Common complications subject to litigation include:
- Filter migration
- Impossible removal
- Device fracture
- Organ damage or perforation
- Blood clots
IVC Filter Removal
At first, the inferior vena cava filter was designed to permanently reside in a patient’s vena cava; thus, there was no method of removal. After reports of complications and studies associating these devices with high failure rates surfaced, manufacturers started designing products with a “retrieval hook.”
In 2010, the U.S Food and Drug Administration issued a warning regarding the dangerous of IVC Filters and recommended guidelines on removal. The following is an official statement by the FDA,
“FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.” (U.S Food and Drug Administration, Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use 2010)
Several years after the initial warning in 2010, the FDA reinforced their position and issued a stronger advisory. In fact, the FDA encouraged doctors and patients to remove retrievable filters as soon as the risk of pulmonary embolism subsides.
Unfortunately, the removal of inferior vena cava filters carry a significant risk of injury in patients. Additionally, when the device tilts, fractures, or migrates, it may severely complicate the retrieval procedure and expose the patient to grave danger.
What Can You Do?
Di Pietro Partners, LLP is a Florida based Law Firm that’s pursuing national claims against certain IVC filter manufacturers including: Cordis, Bard, and Cook filters. The Law Firm features a team of experienced medical device injury and medical malpractice attorneys along with a board certified physician on staff. If you, or someone you know were affected by a defective inferior vena cava filter, call for a free and confidential case evaluation today. 800-712-8462