C.R. Bard Continued Selling IVC Filters Despite Complications. Reports indicate that medical device company C.R. Bard continued selling its IVC blood clot filters despite major complications.
Bard’s Recovery IVC (inferior vena cava) blood clot filter was reportedly linked to 27 deaths and hundreds of complication, Top Class Actions reports. The company removed the Recovery filter from the market in 2005. The G2, which was the replacement for the Recovery, remained on the market until 2010, despite adverse event reports.
IVC blood clot filters are used to prevent blood clots from entering the lungs or heart, where they can cause major complications or even death. The filter-a small, spider-like device-is used in patients who cannot take blood-thinning drugs or for whom the drugs do not work well. C.R. Bard, Cook Medical, and Cordis are three major manufacturers of IVC filters.
Retrievable IVC blood clot filters have been associated with reports of breakage and migration. Fragments of the device can migrate to the heart and lungs, and filter fragments can also migrate to other organs. These fragments can cause grave injuries, including pain, bleeding, vein perforation, organ perforation, and pulmonary embolism, clots and other complications.
Adverse Event Reports
In August 2010, after it had received more than 900 adverse event reports, the FDA issued an advisory about the devices. The FDA warned about the risks again in 2014, recommending that retrievable IVC filters be removed between 29 and 54 days after insertion. Research indicates that IVC filters may become more dangerous than beneficial when they are left in the body longer than two months. But complications can prevent safe removal and the filter must be left in place.
A study in the Journal of the American Medical Association noted that more than 18 percent of attempts at removing IVC filters were unsuccessful. When the filter cannot safely be removed, the patient is at risk for future IVC filter complications.
According to Dr. William Kuo, an interventional radiologist with Stanford Health Care’s IVC Filter Clinic, this device “consistently causes major complications.” Dr. Kuo’s focus is on the removal of failed blood clot filters when a patient experiences filter complications, according to Top Class Actions. The Stanford Division of Vascular and Interventional Radiology has pioneered new endovascular methods to retrieve a variety of IVC filters, regardless of implantation length, which have become embedded within the IVC, the Stanford Health Care website explains.
A number of IVC filter recipients have filed product liability lawsuits, focusing not only on the risks associated with these devices, but in particular how the manufacturers have dealt with those risks. Lawsuits have alleged that complications patients experienced with their filter-removal complications were avoidable, according to Top Class Actions. One plaintiff says pieces of her fractured IVC filter migrated to her heart. When she was told that open heart surgery would be necessary to remove the pieces, the woman chose instead to take anticoagulant medications for the rest of her life. These medications, however, also have risks for those who take them, including uncontrollable bleeding.