Bard IVC Filters Linked To Blood Clots, Heart Problems, And Other Side Effects
Patients who are unable to take blood thinners are at high risk of dangerous clotting after surgery. Many doctors implant small wire cages, called Inferior Vena Cava (IVC) filters, directly into these patients’ veins to catch clots and prevent strokes. Unfortunately, these devices have been linked to a number of serious side effects—and they may not even prevent blood clots from traveling to the lungs or brain.
Side Effects of the Bard Inferior Vena Cava (IVC) Filter
The U.S. Food and Drug Administration (FDA) received reports of 921 adverse events involving IVC filters between 2005 and 2010 alone, many of which were life-threatening. Many injuries were due to the Bard IVC filters breaking apart in the body, sending the sharp metal legs of the device through the bloodstream. Device breakage and migration added to the worrying side effects of the device, which may include:
- Pulmonary embolism. Bard IVC filters may not be positioned correctly, allowing clots to pass through to a patient’s organs. A pulmonary embolism is a serious condition that results when a blood clot becomes lodged in the lung artery. These clots can cause a variety of problems, including difficulty breathing or permanent shortness of breath, low oxygen levels in the blood, and organ damage due to improper circulation. Large clots can cause permanent damage to the lung or even result in patient death.
- Perforation. Over the course of five years, the FDA was notified of 146 patients who suffered detachment of the IVC filter and 56 reports of IVC filter fractures. As pieces broke off of these devices, many speared parts of the body, becoming lodged in the blood vessels, organs, and other tissues.
- Hemorrhages. When a patient suffers perforation in the large veins and arteries of the body, he or she may suffer uncontrollable bleeding (hemorrhage), a potentially fatal condition.
- Heart problems. Patients have suffered a number of heart issues due to IVC filters, including increased heart rate (tachycardia), irregular heartbeat, and fluid collection in the sac that surrounds the heart (pericardial effusion). This compression of the heart and irregular function may result in a heart attack.
- Pain. Even if a migrating IVC filter does not cause life-altering side effects, a patient can suffer severe pain as the legs of the device become lodged in different areas of the body. Depending on where the fragments of the IVC filter migrate, patients may suffer constant pain in the chest, leg, arms, or even in several locations.
Agencies and Researchers Voice Concern About IVC Filters
Not only are patients likely to be injured by IVC filters, many patients who received them may not have needed them in the first place. A study published in the Archives of Internal Medicinein 2010 examined over 1500 patients who were implanted with IVC filters for three years after surgery. Patients with IVC filters had a higher mortality rate during three years of follow-up, but perhaps more worryingly, the study’s authors concluded that an IVC filter was only appropriate in 51% of cases, and in at least 26% of cases the device should never have been used.
In 2014, the FDA released an updated safety warning for Bard IVC filters, advising doctors and patients that the devices should be removed as quickly as possible after surgery, and no later than 54 days after implantation. The company who created the filter conducted its own study into the devices, and found that it was more likely to fracture than other devices on the market. However, Bard did not inform the FDA, doctors, or consumers of the study results. Now patients are banding together against Bard, claiming that the company knew of the dangers and failed to warn surgery patients of the risks.