Bard G2 IVC Filter Also Unsafe – NBC News Follow-up Report
If you or a loved one has been injured by a defective blood clot filter, call the IVC filter lawyers at Thornton Law Firm at 1-888-341-1405 for a free, no obligation consultation, or tell us your story using our online contact form.
In a follow-up to its September report on 27 deaths associated with the C.R. Bard “Recovery” IVC blood clot filter, NBC News reports that Bard knew that its G2 Series IVC filters — intended to replace the company’s Recovery filter — also “had similar and potentially fatal flaws soon after it was put on the market.” NBC obtained internal Bard records showing that Bard was concerned about reported failures of the G2 Series filters just four months after they were approved by the FDA.
But instead of recalling the G2 Series IVC filters, Bard kept them on the market and continued to sell them for implantation in patients with blood clotting disorders for 5 more years, until 2010. More than 160,000 of them were implanted in patients. According to Bard and FDA records, at least 12 patient deaths are linked to the G2 Series IVC filters. There have been hundreds of reports of other device problems.
Like the Recovery IVC filter, the G2 Series IVC filter is a spider-like device with long dangling metal legs meant to catch blood clots and prevent them from entering the heart and lungs, where they can cause death. IVC stands for Inferior Vena Cava, the large vein that carries blood from the lower part of the body to the heart. Unlike other IVC filters, the G2 Series — according to internal C.R. Bard documents — had problems with migration, tilting, and perforation. Bard documents reviewed by NBC showed “the G2 series filters had more fractures, migrations and reported problems than any of its competitors.”
NBC News interviews a interventional radiologist at Stanford, Dr. William Kuo, who specializes in removing failed IVC filters and pieces. Asked whether the G2 is safe for patients, he responds:
“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…The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
He believes the G2 should have been recalled. Senator Charles Grassley, the chairman of the Senate Judiciary Committee, has asked the FDA to explain what actions the agency takes when new information emerges about a device that is already approved. At this time, he says the FDA’s response is incomplete. The agency did recommend in 2010 and 2014 safety alerts that doctors consider removing the devices when protection from blood clots is no longer needed. But the FDA has never recalled them despite all the reports of injuries and deaths.
The injuries from a defective IVC filter can be life threatening. Patients have reported filter fracture, filter migration, punctures of the vena cava, heart or lung perforation, hemorrhage, or cardiac tamponade.
If you believe you or a loved one has suffered injury from a defective IVC filter, call the IVC filter lawyers at Thornton Law Firm at 1-888-341-1405 for a free, confidential consultation, or tell us your story using our online contact form. The time limits for filing IVC filter claims are very short. You should seek legal advice as soon as possible.