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Did you or a loved one have an IVC Filter implanted and developed complications?
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- Bard ordered to pay $3.6 Million
- FDA received more than 900 Adverse Event Reports (2005-2010)
- Device retrievals fail in 2% of attempts
Reported Complications:
- Device migration
- Detachment of device components
- Filter perforated vein or organ
- Filter fracture
- Filter was imbedded in the inferior vena cava
- Filter was protruding through a blood vessel
- Abnormal filter position
- Blood clot inside the filter
- Pulmonary embolus
- Hemorrhage
- Respiratory compromise
- Punctured veins
- Perforation of tissue, vessels, and organs
- Constant severe pain in the heart, chest, or elsewhere
- Death
Regulatory History
1970s: FDA approves permanent IVC filters.
1990s: FDA begins approving retrievable IVC filters.
2001: First retrievable IVC filter becomes available in US.
2002: FDA approves the retrievable C.R. Bard Recovery IVC filter.
2003: FDA approves the Cook Gunther Tulip IVC filter.
2004: First reports of complications with the Recovery IVC filter.
2005: Bard discontinues Recovery IVC filter (doesn’t recall).
2005: Bard releases the G2 IVC filter.
2008: Bard releases the G2 Express IVC filter.
2008: The FDA approves the Cook Select IVC filter.
2010: The FDA issues a warning urging doctors to remove IVC filters as soon as the danger of thrombotic events has passed.
2011: Bard introduces the Bard Meridian IVC filter.
2012: Patients begin filing lawsuits against Bard and Cook Medical, due to complications with the Gunther Tulip and Select IVC filters.
2013: FDA approves the Bard Denali IVC filter.
2014: FDA approves the Bard Eclipse IVC filter.
2014: FDA updates their IVC filter safety warning, citing data that shows the devices should be removed between 29 and 54 days after implantation.
2014: Cook Medical lawsuits consolidated into an MDL in Indiana’s southern district.
2015: Bard lawsuits consolidated into an MDL in Arizona district court.
2016: Bard IVC filter patients file a class-action lawsuits on behalf of anyone with an implanted Bard blood clot filter.
