A medical device, the IVC filter, designed to stop blood clots from traveling to the heart and lungs, has been associated with 27 deaths and hundreds of more problems in its patients. The product manufacturer, C.R. Bard, was notified of potential problems before mass distribution even began, but continued to sell them.
In 2002, C.R. Bard began selling a device called Recovery. Despite receiving clearance from the Food and Drug Administration, reports of deaths and injuries rose steadily along with sales. A study commissioned by Bard showed that “the Recovery filter had higher rates of relative risk for deah, filter fracture and movement than all of its competitors.” It was replaced in 2005 by the G2 and even later by the G2 Express, but neither of these solved the aforementioned problems.
The warnings about these devices were widespread and numerous. First, Kay Fuller, a veteran regulatory specialist who was consigned to help the Recovery get FDA approved, had serious concerns about the device. Once she voiced them, she said, her concerns were swept under the rug. She refused to sign the application, she said, yet the application shows her signature. Second, Dr. William Kuo, a interventional radiologist at Stanford Health Care’s IVC Filter Clinic that specializes in removing failed blood clot filters, has serious problem with the devices. “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,” Kuo said. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.” He also notes that of the estimated 1,000 failed filters he has removed, more of them were made by Bard than any other company.
Just a few of the incidents of filter failure are as follows: Gloria Adams, a 55 year old mother had a brain aneurysm in 2004. Less than a week after her filter was implanted, a clot pushed the entire device into her heart and punctured it. Dodi Froehlich, 45, had to get a filter after a car accident in 2004. Four months after getting it the passed out when a piece of the filter broke off and pierced her heart. Unlike Adams she was fortunate enough to survive. Chris Svedise, a 69-year-old manager of a fish company had a G2 Express filter implanted for blood clots. During emergency surgery Dr. Kuo discovered three of the legs had broken off and traveled to Svedise’s lungs, and two more came off during the surgery.
In 2010 and 2014, the FDA did recommend that doctors remove filters as soon as they aren’t necessary, but never went as far as to recall these sometimes faulty devices. It’s currently estimated there are still more than 20,000 people walking around with these filters inside them. A large clinical study has begun to examine the safety and effectiveness of such filters. However the five-year study may not end early enough to help any of the millions of people with blood clot filters in America currently.
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