For more than a year, NBC has been investigating “a medical device that was designed to save lives but is instead putting lives at risk.”
In a special, two-part feature on IVC filters aired on Sept. 2 and 3, 2015, NBC reporters spoke with a 45-year-old IVC filter recipient who “flat lined” when a fragment from her Recovery® IVC filter broke off and pierced her heart, as well as with a veteran regulatory specialist who was hired by device manufacturer C.R. Bard to help its Recovery® IVC filter pass FDA approval.
According to the report, the Recovery® IVC filter has been linked to at least 27 deaths and is associated with about 300 reports of side effects and other adverse events. Deep vein thrombosis, or the development of a blood clot in a deep vein; filter fracture and movement of the entire filter or filter parts to the heart or lung are just some of the problems reported to the FDA regarding long-term use of retrievable IVC filters.
More than 250,000 Americans are implanted with IVC filters each year, according to NBC, and along with C.R. Bard’s Recovery Filter System®, other IVC filters made by medical device manufacturers such as Cook Medical are also facing scrutiny.
Part two of the feature delved into the device’s approval process, bringing up questions of concealed test results, questionable clinical trials and potential forgery linked to the Recovery® Filter System’s approval in 2002.
In an interview featured in the second segment, regulatory specialist Kay Fuller shares with NBC how she had “serious concerns about the Recovery®” and how C.R. Bard “did not give her important safety performance test results.”
NBC found that C.R. Bard was aware of investigations into problems with the device as early as 2004, and according to a confidential third-party study paid for by C.R. Bard, “the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all its competitors.”
Watch and read part one of the NBC story and read and watch part two.
Motley Rice attorneys have experience in medical device lawsuits, having served in leading roles in litigation concerning transvaginal mesh (TVM), Mirena® IUD and NuvaRing®. Find out more about IVC filters, including potential side effects and cases.