Medical device maker, C.R. Bard allegedly continued to market its Inferior Vena Cava (IVC) filters even after reports of serious injuries and deaths.
A yearlong investigation by NBC Nightly News indicates that the IVC filters were failing and leading to significant injuries and deaths at rates considerably higher than other similar devices.
The Bard IVC filter—a small, cone-shaped device—is implanted into the inferior vena cava, the large vein that carries blood from the lower body back to the heart. The filter device is meant to prevent a blood clot from reaching the patient’s heart or lungs, according to NBC News. Approximately 250,000 IVC filters are implanted annually.
Reports indicate that the Bard IVC Recovery device migrates from where it is placed, fractures, perforates the vein, and causes—not prevents—clots. The NBC News investigation linked 27 deaths and more than 300 injuries to failures associated with Bard’s Recovery model IVC filters. NBC News asked why Bard did not recall the Recovery filters even after a confidential study the company commissioned “urgently” requested additional investigation into the device’s performance.
The Food and Drug Administration (FDA) issued a serious warning to Bard because Bard allegedly did not file customer complaint reports involving injuries and deaths related to the device and never advised the FDA that the Recovery Cone Removal System suffered from dangerous defects. Recovery devices may also have problems with cleaning processes, which were allegedly never validated. The FDA’s more serious warning and steps taken to suspend the Bard devices took place after Bard allegedly did not appropriately respond to the FDA.
The NBC News two-part investigative report described the case of a patient implanted with the Bard Recovery IVC filter in 2004 after a car accident. She had a pelvic fracture and was deemed to be at greater risk for a blood clot because of required immobilization. “The filter was supposed to stop [clots] from reaching her heart or lungs; instead, it nearly killed her,” according to NBC News. Four months after the filter implant, she developed a severe headache, fainted, and then flat-lined in the ambulance on the way to the hospital. Doctors discovered that a piece of the IVC filter had broken off and pierced her heart. She needed open-heart surgery to remove the device fragment and repair the perforation. Another woman implanted with an IVC filter following a 2004 brain aneurysm, died. The autopsy revealed that the filter entered her heart via clot, puncturing the heart.
A regulatory specialist hired by Bard to help with the application for FDA approval said she told Bard she would not sign the application because of concerns about test results. She said her signature “appears to have been forged on the paperwork,” according to NBC News. Bard denied the forgery accusation and said all of its “vena cava filter devices have been appropriately cleared by FDA.
In August 2010, the agency issued a safety communication concerning risks associated with long-term use of IVC filters and urged doctors to consider removing the devices after the risk of pulmonary embolism has passed. The FDA’s safety communication was updated in May 2014 with additional information.