Confidential records from medical device company C.R. Bard obtained by NBC News show that the company continued to sell one of its blood clot filters despite reports of potential fatal flaws.
According to the NBC News report, C.R. Bard tried to replace a former model of a blood clot filter that was associated with dozens of deaths, but discovered that the replacement filter had the same problems. The confidential records show that despite the concern, C.R. Bard continued to sell the new filter for five year.
C.R. Bard introduced their first blood clot filter, the Recovery, in 2002; however, the company soon faced reports of the Recovery IVC filter moving and breaking, leading to removal and even death. Despite those reports and an internal study by the medical device company that found the device had problems, C.R. Bard kept the blood clot filter on the market until 2005 when it introduced a similar G2 series of blood clot filters.
The Food and Drug Administration cleared the device for the market, but a short four months later, the company began receiving reports that the G2 blood clot filter had similar issues, including migrating, tilting, and perforation. NBC News reports that a confidential memo from the vice president of C.R. Bard notes these IVC filter problems and that another of the company’s filters had almost no complaints.
“Why shouldn’t doctors be using that one rather than the G2?” says the confidential memo obtained by NBC News.
Despite the reports that the G2 blood clot filter was tilting, migrating and perforating patients’ inferior vena cava veins, C.R. Bard kept the product on the market until 2010, reports NBC News. A future document finds that the G2 series blood clot filters had higher rates of problems than competing IVC filters.
NBC News reports that 12 deaths have been associated with the G2 series blood clot filters along with hundreds of problems according to FDA records.
Problems with Bard G2 Series Blood Clot Filters
“All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” said the director of Stanford Health Care’s IVC Filter Clinic. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
The G2 series blood clot filters are shaped like spiders and were placed in the largest vein in the body, the inferior vena cava, to help stop blood clots. One patient reported that his G2 series blood clot filter had to be removed because several of the “legs” of the device had broken off and the device itself had moved. His doctors found the legs in his lungs and the device dangerously close to his heart, says the patient.
The FDA has recommended removing blood clot filters from patients as soon as they are no longer needed.
IVC Filter Lawsuits
Legal claims have been filed over blood clot filters and can help you or a loved one recover damages for injuries, economic loss and emotional harm.
The IVC blood clot filter attorneys at McDonald Worley are experienced at investigating claims against IVC filter manufacturers and will help you determine whether filing an IVC filter lawsuit is right for you. Submit your information now for a FREE case evaluation using the form on this page.