Bard G2 Express & G2x IVC Filter

bard express ivc filterRetrievable inferior vena cava filters, such as C.R. Bard, Inc.’s G2 Express and G2x IVC filters, may be associated with a fracture rate as high as 12%. If not removed once the risk of pulmonary embolism has passed, these devices may place patients at risk for life-threatening complications related to fracture, migration and embolization.

Our IVC Filter Attorneys Can Help

The nationwide law firm of Bernstein Liebhard LLP is currently accepting case inquiries from individuals who may have been seriously injured by a Bard IVC filter, including the G2 Express and G2x devices. If you or a loved one experienced any of the complications allegedly associated with one of these retrievable IVC filters, please contact our Firm at (888) 994-5118 to discuss your case with an experienced medical device attorney today.

G2 Express & G2x IVC Filters

Devices like the Bard G2 Express and G2x IVC filters are implanted in the inferior vena cava in order to capture blood clots before they can travel to the lungs and become a pulmonary embolism. They are generally used to treat patients who are at risk for blood clots, but for one reason or another are unable to use standard anticoagulant therapy. Clots are captured by the IVC filters’ small, spider-like struts.

As retrievable filters, both the G2 Express and G2x devices are intended to be removed from the body once the threat of pulmonary embolism has passed. However, a study published by JAMA Internal Medicine in March 2013 indicated that only 10% of IVC filters are removed successfully. The same study also questioned their efficacy, finding that roughly 8% of patients implanted with an IVC filter still experienced a pulmonary embolism.

FDA Issues Two Warnings for Retrievable IVC Filters

In 2010, the U.S. Food & Drug Administration (FDA) issued the first of two warnings regarding retrievable IVC filters. The agency expressed concern that the devices, intended for short-term placement, are not always removed once a patient’s risk for pulmonary embolism subsides. The alert revealed that the FDA had received 921 reports of complications involving such filters since 2005, many of which resulted in adverse outcomes for patients. These complications included:

  • 328 instances where the filter broke away from the implant site and migrated elsewhere in the body
  • 146 involved embolization (filter components broke loose)
  • 70 cases of IVC perforation
  • 56 involved filter fractures

In an updated communication issued in May 2014, the FDA noted that the risks associated with retrievable IVC filters include:

  • Filter fracture
  • Filter migration
  • Filter embolization
  • IVC (inferior vena cava) perforation
  • Lower limb DVT (deep vein thrombosis)
  • Filter occlusion

To lessen the risk of complications, the agency advised that retrievable IVC filters should be removed between 29 and 54 days after implantation.

G2 IVC Filter: What’s the Problem?

Both the G2 Express and G2x devices are very similar in design to another C.R. Bard retrievable IVC filter called the G2. One recent study involving 548 people implanted with a Bard Recovery, G2, or G2 Express indicated that the G2 IVC filter was associated with a 12% fracture rate. In 13% of the filter fracture cases, the broken components embolized to other areas of the body.

NBC Investigates G2 IVC Filter Safety

In December 2015, NBC News broadcast an investigative report on Bard’s G2 IVC filter series. Among other things, the network revealed that failures of the G2 had been linked to at least a dozen deaths. The report also disclosed evidence that officials at Bard were aware of serious problems with the G2 series just months after the devices had been approved by the FDA. Read More

Bard IVC Filter Litigation Update

August 2015: Federally-filed Bard IVC filter lawsuits have been consolidated in the U.S. District Court, District of Arizona, for the purpose of coordinated pretrial proceedings. Twenty-two cases were initially transferred to the new multidistrict litigation. By December 2015, the federal litigation had grown to include more than 60 cases. Read More

Learn More about Filing Your Own IVC Filter Lawsuit

You may be eligible to file a claim in this litigation if you or a loved one suffered any complications that may be associated with the use of a G2 Express or G2x IVC filter. To arrange for a free, no-obligation review of your case, please contact Bernstein Liebhard LLP today at (888) 994-5118.

  1. FDA (2010) “Removing retrievable Interior Vena Cava Filters: Initial Communication” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm
  2. FDA (2014) “Removing retrievable Interior Vena Cava Filters: FDA Communication” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm
  3. Journal of Vascular and Interventional Radiology (2012) “Fractur
  4. JAMA Internal Medicine (2013) “Indications, Complications, and Management of Inferior Vena Cava Filters” http://archinte.jamanetwork.com/article.aspx?articleid=1669107
  5. ed Bard Recovery, G2, and G2 express inferior vena cava filters: incidence, clinical consequences, and outcomes of removal attempts.” http://www.ncbi.nlm.nih.gov/pubmed/22173108

 

Last Modified: January 8, 2016

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