Bard IVC Filter

Bard IVC filters are medical devices placed in the inferior vena cava of the heart, with the intention to catch blood clots and stop them from traveling to the heart or lungs. Recent studies have shown that the filters have no efficacy. In fact, the filters have been shown to double the risk of pulmonary embolism, the very condition which they are intended to prevent. Three brands in particular are noted in lawsuits as a source of problems: The Bard Recovery filter, The Bard G2 filter, and The Bard G2 Express filter.

Bard IVC filters are medical devices placed in the inferior vena cava of the heart, with the intention to catch blood clots and stop them from traveling to the heart or lungs. Recent studies have shown that the filters have no efficacy. In fact, the filters have been shown to double the risk of pulmonary embolism, the very condition which they are intended to prevent.  Three brands in particular are noted in lawsuits as a source of problems: The Bard Recovery filter, The Bard G2 filter, and The Bard G2 Express filter.

FDA Warnings About the Safety Risk of Bard IVC Filters:

On or about November 27, 2002, Bard obtained Food and Drug Administration (“FDA”) clearance to market the Bard IVC Recovery filter device and/or its components as a permanent IVC filter under Section 510(k) of the Medical Device Amendments. Bard’s notification of intent to market asserted that the Recovery filter was substantially equivalent to the Simon Nitinol Filter (“SNF”), their “predicate device”. On July 25, 2003, The FDA cleared the Bard IVC Recovery filter for the additional intended use of optional retrieval.

The Bard IVC Recovery filter quickly proved to be problematic for Bard in that it presented an increased risk of fracturing, titling within the inferior vena cava, perforating the wall of the inferior vena cava (frequently penetrating into other organs and tissues such as the aorta and duodenum), and migrating through the body.

Although the filters were designed to prevent the life-threatening pulmonary embolism (PE) – blood clots in the lungs – they actually have life-threatening side effects. In a report released in 2010, the FDA received more than 900 reports of adverse events associated with IVC filters. The adverse events listed in the FDA report include:

  • 70 filter perforations
  • 328 device migrations
  • 56 filter fractures
  • 146 embolization. The components of the device became detached.

IVC Filter Fracture

The risk of IVC filter fracture is one of the most serious complications of the Bard IVC Recovery and Bard G2 IVC filter. These devices are implanted in a patient’s inferior vena cava (IVC), which is the blood vessel between the heart and the lungs. They are designed like a wire cage, with thin wire legs (called “struts”) that catch blood clots before they travel into the patient’s lungs and cause a pulmonary embolism. The Recovery and G2 are retrievable IVC filters — they are supposed to be removed after the patient is no longer at risk of a pulmonary embolism. The risk of filter fracture increases the longer these temporary devices remain in a patient’s body.

The Bard Recovery IVC filter was linked to a 40% fracture rate after 5.5 years. Bard withdrew the Bard IVC Recovery filter in 2005. Since 2005, the FDA has received more than 900 adverse event reports of severe, life-threatening IVC filter side effects which led them to publish a Safety Communication in 2010 discussed above. 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 pulmonary embolism (PE) has subsided. The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.” It has also been noted that there have been around 100,000 patients who have had an IVC device implanted since it was approved. Some estimate that 1 in 4 people who have an IVC filter device implanted will experience some sort of breakage. People who have had the IVC device for years are at a greater risk of injury.

Bard then re-designed the Bard IVC Recovery and re-named it the Bard IVC G2, claiming the improved device was less likely to fracture or migrate. However, researchers have linked the Bard IVC G2 to a 12% fracture rate, as noted in one study mentioned below. When an IVC filter fractures, the broken pieces of the device can become an embolization— they travel in the bloodstream. If they travel to an internal organ (such as the heart, lungs, kidneys, or other area of the body) they can cause severe internal injury.

Studies of IVC Filter Fractures

  • One study, published in February 2012, found that the Bard G2 IVC filter is associated with a 12% rate of filter fractures. The researchers also found that doctors successfully removed fractured pieces of the device in just 53.4% of cases. They warned that the risk of fracture increases over time.
  • Another study found that fractured filter struts (the spider-like legs of the device) are often impossible to remove. The study described cases where the fractured pieces embedded into the heart, inferior vena cava, lungs, or other blood vessels.
  • This following study found that 40% of Bard Recovery IVC filters fractured after 5.5 years. The report described cases where the fractured pieces traveled to the pulmonary arteries, femoral veins, heart, and kidney vein. Other fragments embedded near the filter. One fragment could not be located.
  • A study, published in 2010, warned “The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.” Many patients had filter fragments move into the heart, causing potentially life-threatening cardiac tamponade, ventricular tachycardia, and sudden death.
  • A study published in the Journal of Anesthesiology in 2012 described the case of a man who suffered cardiac tamponade and acute pericardial effusion as a complication of a small wire fragment from an IVC filter that was placed several years before the incident.
  • A 2013 study looked at the indication, complication and management of IVC filters (some were Bard IVC filters) in 952 patients in a Level 1 trauma center. Approximately 680 retrievable IVC filters were placed in patients. There were 608 patients who didn’t have the filters removed. Approximately, 58 patients had their filters successfully removed. Out of the remaining 13 patients where removal was unsuccessful, the study results revealed:
    • 8 patients couldn’t have their filters removed because the devices were embedded
    • 3 patients couldn’t have their filters removed because the filters projected of the blood vessel
    • 2 patients couldn’t have their filters removed because the devices migrated to an abnormal position
    • 1 patient had a blood clot located inside the filter
    • In the 13 unsuccessful removals, 11 patients had their filters for more than 85 days.

IVC Filter Fractures and Heart Injuries

Bard IVC filter embolizations to the heart have been associated with several life-threatening heart injuries, including:

  • Cardiac tamponade
  • Hemorrhagic pericardial effusion
  • Ventricular tachycardia
  • Perforation of the heart
  • Embedment / erosion into the heart
  • Laceration of the heart
  • And more

Fractured pieces of a Bard  IVC filter can also travel to the lungs, perforate the inferior vena cava, or travel to other parts of the body and cause severe organ damage. The people who suffer these complications often require emergency surgery and intensive care.

 

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