NBC Nightly News investigated controversial medical devices, known as IVC filters, used to prevent blood clots. The news organization separated their findings into broadcasted segments to show how unsafe filters impact consumers and illustrate that manufacturers knew about design flaws.
27 Fatalities And Other Complications
Part one of the investigative series revealed that 27 individuals died from IVC filter problems in the last decade. In addition, there were 300 reports of other complications. The device in question, C.R. Bard’s Recovery filter, is implanted in the inferior vena cava vein to stop blood clots.
One of the thousands of people implanted with IVC filters, a 45-year-old woman named Dodi Froehlich, nearly died when a part of the IVC filter broke off and moved to her heart. She had the device implanted after a car accident that made her more susceptible to clotting, NBC reports.
Another woman, 55-year-old Gloria Adams, died after a powerful blood clot propelled the entire spider-like IVC device to her heart. The filter was meant to protect her after a brain aneurysm.
One of the main components of the investigation is an attempt to find out if C.R. Bard knew about the device failures and health risks.
Hiding Study Results To Sell Products
Patients began to speak out about complications. Instead of issuing a recall, C.R. Bard hired a public relations firm for damage control. Simultaneously, the device manufacturer privately researched IVC filter complications.
The study showed that the IVC filter Recovery model was associated with a greater risk of fracture, migration and early death. C.R. Bard kept the results hidden and continued to sell thousands of rebranded filters, NBC reports.
Despite initial difficulties with FDA clearance and insufficient clinical trials, the company claims that the product meet federal safety standards. Representatives from C.R. Bard issued a statement that IVC filters offer “significant benefits to patients.”
Kay Fuller, a regulatory affairs specialist hired by Bard to help get FDA approval the second time around, noticed safety issues and reported them to the FDA. NBC investigators discovered that Fuller’s signature on the FDA application appears to be forged, which she confirmed in an interview with the news organization.
NBC reports that more than 20,000 people are implanted with IVC filters. Individuals who experienced complications may be entitled to a lawsuit.
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