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A recent NBC News report raised serious questions about the safety of Bard IVC filters.

These filters are implanted in the inferior vena cava (IVC)—the vein taking blood from the lower legs back to the heart—in patients who are at risk of pulmonary embolism (PE), or a blood clot in the lungs. The small, cage-like device captures and traps blood clots before they can reach the lung, reducing risk of PE, but studies have also linked them to serious side effects, such as perforation and migration.

NBC reported that 27 deaths have been associated with the Bard Recovery IVC filter over the past ten years, with an additional other 300 reports of injuries associated with the devices. Reporters went into details on one of those injuries that occurred in a 45-year-old Florida woman. She was implanted with the Bard Recovery in 2004, and four months later, ended up in the hospital because of a severe headache. Doctors discovered that a piece of the filter had broken off and pierced her heart.

NBC Digs Into Bard IVC Filter Defects

A study published in 2010 revealed that Bard Recovery IVC filters were prone to fracture and migration. Researchers examined patients who received a Bard Recovery or Bard G2 IVC between April 2004 and January 2009, and found that 16 percent of the filters fractured. Five of the patients ended up in similar situations as the woman mentioned above, and had filter fragments lodged in their hearts.

According to NBC, about 250,000 filters are implanted in Americans every year, but questions about their safety have been increasing lately. In 2010, the FDA announced that they were investigating the devices because they had received over 900 reports of problems with them, including device fracture and migration, and perforation of the inferior vena cava.

NBC reported on another woman who actually died a week after being implanted with an IVC filter in 2004. An autopsy showed that a blood clot had pushed the filter into her heart. The news team also obtained an independent study conducted in 2004 by a doctor hired by Bard. The study reported that the Recovery filter increased risk of death more than any other type of IVC filter, and urgently recommended additional studies.

Despite these concerns, Bard continued to sell the Recovery until they replaced it with the G2 model a few years later.

Injured Plaintiffs Seeking Compensation from Bard

In May 2014, the FDA issued an updated safety communication recommending that all IVC filters be removed within 29 to 54 days of implantation, as long as protection from PE was no longer needed. They’ve also required manufacturers like C. R. Bard and Cook Medical conduct additional studies on the devices to further investigate their safety and effectiveness.

In August 2015, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Bard IVC filter lawsuits into the District of Arizona for pre-trial proceedings. These lawsuits were filed by plaintiffs who suffered injuries from the Bard Recovery IVC filter, but also from the Bard G2 and the Bard G2 Express.

Bard has already agreed to a settlement in one IVC filter lawsuit filed by Kevin Philips. He claimed the filter fractured and perforated his heart, requiring open-heart surgery. The details of the settlement were not revealed.

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