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Two retrievable inferior vena cava (IVC) filters sold by C.R. Bard, Inc. to help prevent blood clots from causing a pulmonary embolism have been found to have a high failure rate, according to a new study. The Bard Recovery IVC filter and Bard G2 IVC filter could fracture or migrate, potentially leading to a life-threatening injury for individuals who had one of the the small filters implanted.
In a study released this month by the Archives of Internal Medicine, researchers examined the failure rates for the first generation Bard Recovery IVC filter and second generation Bard G2 IVC filter. The prevalence of fracture and embolization with the vena cava filters was so severe that the researchers who conducted the study indicated that further implantation of the two devices has been halted at their own institutions.
Inferior vena cava filters are an alternative treatment for patients at risk for a pulmonary embolism. They are often used when an anticoagulant is contraindicated or if such medications have not been effective. They contain a number of legs or struts that extend out like a spider to catch blood clots that may break free elsewhere in the body. However, if there is an IVC filter strut fracture, small pieces of the filter may travel to other parts of the body, such as the heart or lungs.
Earlier this month, the FDA issued a safety alert about the risk of problems with IVC filters, but did not specifically identify any particular model or manufacturer. The agency indicating that it has received more than 900 reports of vena cava filter failures, including cases where the IVC filter broke free and migrated through the body, perforated of the vena cava and reports where the IVC filters fractured. As a result, the FDA warned doctors that they should monitor patients and remove retrievable IVC filters once the risk of the clot has passed.
In the Bard IVC study, researchers looked at 80 patients who received either the Bard Recovery Filter, which was available from 2003 until 2005, or the Bard G2 Filter, which was introduced as a second generation filter in 2005. Thirteen of the 80 patients were found to have at least one strut of the IVC filter fracture (16%). Among individuals implanted with the first generation Recovery vena cava filter, the fracture rate was 25%, with the filter fragments traveling to the heart in 71% of the fractures. With the newer Bard G2 filter, the fracture rate was also found to be high, with 12% of the G2 IVC filters fracturing.
The Bard IVC filters contain nitinol metal, which gives the filter “shape memory.” However, the researchers indicated that nitinol metal may play a role in the filter fracture. Therefore, they indicated that it is reasonable to assume that the incidence of filter fracture would be directly proportional to the time that the filter is allowed to remain in the patient after implantation.
A number of Bard IVC filter lawsuits have been filed against the company over the last year. In June 2009, eight plaintiffs filed product liability and negligence claims against C.R. Bard, alleging that they had suffered injuries as a result of Bard Recovery IVC filter problems. A similar lawsuit was filed by a couple in federal court in New York that same month, alleging that C.R. Bard has known since 2003 that the Bard Recovery system was a defective device that was causing injury and death among patients.
Bard IVC filter lawyers are continuing to review potential lawsuits for individuals with a vena cava filter implanted since 2003, who have experienced problems that may be linked to migration or fracture of a Bard IVC filter.