Bard Recovery ® IVC filters first entered the market in 2002. The implanted medical devices were intended to prevent blood clots from reaching the lungs through the pulmonary artery. Without such devices, patients with thromboembolic diseases, or those at risk of pulmonary embolism and unable to take an anticoagulant, would face life-threatening complications.
However, the devices themselves have proven to be defective and have a high rate of failure, causing complications that may lead to perforations of other bodily organs or tissue, artery blockage and migration to the heart. Between 2005 and 2010, the FDA received more than 1,000 adverse event reports relating to Bard IVC filters.
Introduction Of The Bard G2 ® IVC Filter System
In 2005, the company gained FDA clearance to market the Bard G2 ® IVC filter system. It was a redesigned device intended to substantially reduce the rate of failure, but in reality did not meet the expectations of the company’s marketing campaign.
A 2010 study published in the Archives of Internal Medicine found that Bard G2 ® IVC filters had a 12 percent fracture rate. The same study found a 25 percent rate of complications among Bard Recovery ® IVC filters in patients. Among patients who experienced filter fracture, 70 percent of cases involved filter migration to the heart.
These are staggering figures, and a number of other published studies have concluded the rate of failure among Bard IVC filters to be between 21 and 31.7 percent. When filter fragments migrate to the heart, symptoms such as rapid heartbeat and fluid buildup can cause severe, life-threatening complications, including sudden death.
Clearly, Bard has failed to adequately address these risks and take the necessary steps to protect patients. The company has even failed to properly inform doctors of the potential dangers involved with the implantation of these devices.
If you or a loved one has experienced health complications relating to a Bard IVC filter system, contact us today to discuss your legal options for financial compensation with an experienced IVC filter litigation lawyer.
At Lee Murphy Law Firm in Houston, our lawyers represent clients throughout the United States, including Texas, New York and California.