FDA Warning for IVC Filter Side EffectsSeptember 5, 2012 — If you have suffered a severe complication caused by a Bard IVC filter, you are not alone. In August 2010, the U.S. Food and Drug Administration (FDA) warned that they had received 921 adverse event reports regarding IVC filter side effects. These cage-like wire devices are implanted to catch blood clots that would cause a deadly pulmonary embolism. They are usually implanted in people who are contraindicated for a blood-thinning medication. Unfortunately, IVC filters may actually cause deadly side effects.

 

In a Safety Communication dated August 9, 2010, the FDA reported the following severe, life-threatening IVC filter side effects:

  • 328 reported cases of migration
  • 146 reported cases of embolizations (when parts of the filter break off and travel in the bloodstream)
  • 70 reported cases of a perforated inferior vena cava
  • 56 reported cases of fractured filter

The FDA found that adverse events often occurred in patients who were implanted with a recoverable IVC filter. These devices are supposed to be removed when the risk of a pulmonary embolism subsides. When they are not removed, the risk of complications increases significantly.

The FDA warned,

“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.”

The agency concluded by recommending that doctors carefully weigh the risks and benefits of using the IVC filter before implanting it in a patient. Once the risk of a pulmonary embolism subsides, the IVC filter should be removed as soon as it is feasible and feasible.

Despite the FDA warning, IVC filter injuries continue to occur. C.R. Bard, the company that manufactures the recoverable IVC filter, claimed to improve the design and called it the G2 IVC filter. Unfortunately, like Bard’s other recoverable IVC filter, the G2 has been linked to a high risk of filter fracture. The Archives of Internal Medicine published a study in 2010 linking the G2 IVC filter to a 12% risk of filter fracture.

The FDA and other experts have warned that filter fracture and other side effects are more common when the device is left implanted in a patient’s body longer than necessary. The spider-like legs (“struts”) of the device can erode into the inferior vena cava or break off. The fractured pieces can perforate internal organs and cause life-threatening heart damage.

Other severe side effects linked to the IVC filter include:

  • Device migration
  • Device erosion into the inferior vena cava
  • Filter fracture
  • Embolizations (broken pieces of the filter moving into the heart, lungs)
  • Perforated inferior vena cava, heart, lungs
  • Hemorrhagic pericardial effusion (fluid and/or bleeding around the heart)
  • Cardiac tamponade (when fluid around the heart inhibits heartbeats)
  • Deep Vein Thrombosis (blood clots in the lower legs that can cause a pulmonary embolism)
  • Narrowing or obstruction of the inferior vena cava, which can slow down blood flow through the heart
  • Edema (fluid and swelling in the lower legs)
  • The IVC filter may be clogged with blood clots
  • And more

IVC Filter Lawsuit Information

Free Confidential Lawsuit Evaluation: If you or a loved one has an IVC Filter, our lawyers would like to speak with you immediately. We are evaluating every case regardless of whether you experienced side effects or not. You may be entitled to compensation by filing a lawsuit. Please use the form below to contact our lawyers or call us toll free 24 hours a day at (866) 879-3040.

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