IVC filters, which is short for Inferior Vena Cava filters, are small cone-shaped metal devices with legs that extend to intercept and trap blood clots. IVC filters, also known as Greenfield filters, are usually implanted in patients who are at risk of developing a pulmonary embolism or blood clot in the lungs.
Did Bard know about the IVC Filter Complications when Selling the Device?
In April 2003, Bard introduced the Recovery IVC filter. Bard redesigned the device and released the Bard G2 IVC filter in October 2005 under a different name due to reports of numerous broken filters. NBC Nightly News reporter calls these reports an “emerging crisis” and questions whether Bard knew the severity of the problem.
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. {1}
IVC Filter can Migrate or Fracture
The filter has shifted or migrated to another area of the body, making it almost impossible to remove.
The IVC filters fracture sending pieces of metal into the abdomen, lungs, liver, kidneys and even the heart. These metal pieces are very sharp and can cause a good deal of damage. Surgery may be necessary to remove the fractured piece to prevent further injuries. There are instances where the surgeons are required to leave the fractured piece inside the organ to prevent irreparable damage during removal.
IVC Filter can Cause Serious Side Effects
Many patients have reported experiencing serious problems, including:
- Heart or Lung Perforation
- Organ Puncture
- Internal Bleeding (Hemorrhagic Pericardial Effusion or Other Hemorrhage)
- Cardiac Tamponade or Pericardial Tamponade
- Punctured Veins or Punctured Vena Cava
NBC Nightly News has recently released a two-part special on this issue. Those reports question the extent of Bard’s knowledge of the filter problems and allege that Bard forged documents submitted to the FDA for approval when releasing the filters onto the market.
Watch the NBC Nightly News reports here, Part 1 and Part 2.
If you or a loved one has been injured when an IVC filter fractured or migrated, contact Chelsie King Garza for a free consultation.
