Free Consult Regarding Bard G2, Bard Recovery or Bard Denali IVC Filter

Our law firm is providing free consultations to people who had any of the following implanted:

  • Bard G2®
  • Bard Recovery®
  • Bard Denali®.

The Bard G2, Bard Recovery, and Bard Denali are inferior vena cava (IVC) filters, medical devices that are inserted into the inferior vena cava, the main vein in the body, to capture blood clots and prevent them from reaching the lungs and heart. IVC filters are implanted in patients at risk for pulmonary embolism (a blood clot in the lungs) when medications are not effective.

In 2010, the FDA issued a safety communication regarding IVC filters. In that communication, the FDA stated:

Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided.

The FDA stated that retrievable IVC filters (intended for short-term placement) have long term risks, including but not limited to, lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

In 2014, the FDA updated the safety communication:

The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.

Because of the long term risks, the FDA recommended that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters should consider removing the IVC filter as soon as protection from pulmonary embolism is no longer needed. According to the FDA, a patient should be referred for EVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status. To help with this, the FDA developed a decision analysis, which leans toward removal if the risk of pulmonary embolism has passed, often between 29 and 54 days after implantation.

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Category: Product Liability
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