Bard Retrievable IVC Filters
The Northwestern University study (mentioned above) investigated six different Bard IVC filters as well as the Cook filters and several other brands. The six Bard filters were the Recovery, G2, G2X, G2 Express, Eclipse and Meridian. Filter fracture and limb embolization (the movement of a fractured filter leg through the IVC to another location, such as the heart or lung) were both higher for the Bard filters than any of the other filters investigated. For more information on complications linked to this filter, visit the Bard IVC Filter page.
Optease IVC Filter
In May 2015, the journal Thrombosis Research published a study of 142 patients who experienced a major trauma (71 were involved in motor vehicle accidents) and were treated with an Optease IVC filter. The formation of blood clots in a vein (known as “venous thromboembolism”) is often seen in trauma patients. The researchers reported that despite the use of anticoagulant medication, 13% of the patients developed blood clots (deep vein thrombosis) and IVC thrombosis (clogging of the filter due to blood clots). The authors suggest that the Optease IVC filter, due to its design, may be a “prothrombotic device”, i.e., it may actually promote the formation of blood clots. Removal of the filter was unsuccessful in 13 patients. The doctors expressed concern over the “persistent complications” related to the use of these devices and stated that their routine use in trauma patients “may not be desirable.”
TrapEase IVC Filter
A Japanese study of Cordis’ permament TrapEase IVC filter found that patients who received this filter were at “extremely high risk of strut fractures” as early as two to three years after placement of the filter.
The PRESERVE IVC Filter Study
Approximately 2,100 subjects are currently being enrolled in a five-year study of IVC filters known as the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study. Filters made by seven different IVC filter manufacturers will be tested and 300 subjects will be enrolled for each filter. The seven filters to be tested (and their manufacturers) are as follows:
- ALN Vena Cava Filter (ALN Implants Chirurgicaux)
- Option™ Elite Retrievable Vena Cava Filter (Rex Medical)
- VenaTech® LP Vena Cava Filter (B. Braun)
- Cook Günther Tulip Vena Cava Filter (Cook Incorporated)
- DENALI® Vena Cava Filter System (C.R. Bard Peripheral Vascular, Inc.)
- OptEase® Retrievable Vena Cava Filter/ Cordis TrapEase® Vena Cava Filter (Cordis Corporation)
- Crux® Vena Cava Filter System (Volcano Corporation)
The study will investigate the major IVC filter complications that have been associated with these medical devices. These include:
- Penetration of filter legs through the inferior vena cava wall resulting in:
- hemorrhage or hematoma
- touching or perforation of other organs
- a decision to remove the filter
- Movement of the filter or its parts to a distant site (e.g., heart, lungs).
- Occlusion (blocking) of the inferior vena cava. This can be caused by the filter capturing blood clots or the tendency of the filter to promote the formation of blood clots.
- Deep vein thrombosis that occurred after the implantation of the filter.
- Other serious adverse events.
The project is being guided by the IVC Filter Study Group Foundation, which is jointly sponsored by the Society for Vascular Surgery (SVS) and the Society of Interventional Radiology (SIR). The filter manufacturers are funding the research and collaborating with New England Research Institutes Inc. (NERI) in carrying out the study.
Taking Legal Action
If you or someone you know has been injured by an IVC filter, or is living under the threat of possible injury, the IVC filter lawsuit team at Baum, Hedlund, Aristei & Goldman would like to hear from you. You may contact an IVC filter attorney by filling out the IVC Filter contact form or by calling us at 1-800-827-0087.