The Dangers of Bard IVC Filters
There has been a lot of talk and many health concern expressed over inferior vena cava (IVC) filters manufactured by C.R. Bard in recent years because of their potential for disaster and not without good reason. An IVC filter is a tiny device that looks a bit like a spider and they are used to prevent blood clots from migrating from the lower body to the heart or lungs. Unfortunately, a number of warnings have been made about these filters because they are meant to be temporary, and if they are not removed in time, they can break apart and the pieces can migrate to the heart and lungs, perforate the vein or even migrate to other parts of the body, where they may cause infection.
FDA Concerned About IVC Filter Side Effects
The Food and Drug Administration has been making its concerns about the filters known for a very long time. More than five years ago, in August 2010, they issued a Safety Communication expressing concern that physicians weren’t removing temporary, retrievable IVC filters quickly enough after the patient’s risk of a pulmonary embolism had subsided. The trigger for that warning was 921 adverse event reports, including 328 events involving migration; of those, 146 of those migration episodes coming after the filter broke apart and 70 of them resulted in perforation of the vein itself. They believed that the incident primarily occurred because the filters were left in the patient for extended periods of time.
Subsequently, in 2014, the FDA issued further recommendations that Bard IVC filters be retrieved in less than 54 days, as long as the patient was no longer at risk for a pulmonary embolism. That very specific recommendation came after a study of patients who had been given Bard IVC filters demonstrated a high rate of device fracture and embolization, meaning the pieces migrated to the heart or lungs. The doctor who conducted that study was prompted to do so when he noticed that a Bard IVC filter had left a patient with chest pain, fluid buildup around the heart and a perforation of his right ventricle. His study found that fully 25 percent of the Bard IVC filters he had put into patients in order to prevent pulmonary embolisms had fractured and become embolisms themselves. He found the results to be so significant that he had to publish them in the Archives of Internal Medicine.
There have been numerous lawsuits filed and a lot of research done on Bard IVC filters over the years, and a number of very troubling side effects have presented themselves. The most common side effects include the following:
- The Bard IVC filter can shift position or migrate to a position where it is not supposed to be and become either ineffective or potentially damaging to internal organs.
- Depending on where it migrates, even a removable filter can end up in a part of the body where the surgeon can’t get to it.
- The filter can become clogged with clots, which can restrict blood flow from the lower body into the heart.
- The filter can erode or perforate the inferior vena cava, creating significant damage.
- The embolization of the filter, meaning it can travel to the heart or lungs.
Thousands of people throughout the country, including many in Texas, have been implanted Bard IVC filters, particularly the G2 and Recovery filters, which means they have been exposed to a heightened risk of serious injury that is potentially life-threatening, should the Bard IVC filter fracture, migrate or fail. Bard has never properly warned patients and physicians of the full risk of the devices and they avoid adequate warnings to this day. That failure to warn physicians or the public means people who have been given a Bard IVC filter may be entitled to financial compensation.
If you have received a Bard G2 or Recovery IVC filter, please contact the attorneys at Blizzard Law PLLC for a free consultation, to see it you have a potential claim. All cases are handled on a contingency fee basis, which means that there are no fees or expenses unless we win your case.