FDA ALERT FOR IVC FILTERS!

FDA CALLS FOR REMOVAL OF IVC FILTER DEVICE AS SOON

AS THE RISK OF PULMONARY EMBOLISM IS GONE. SAYS

"RISK OF INJURY OUTWEIGHS THE BENEFIT"

OF ALLOWING AN IVC FILER TO REMAIN IMPLANTED.

SERIOUS COMPLICATIONS from IVC Filters include:

• • Detached device components (called embolization)
  • Filter migration (movement)
  • Filter Fracture (broken/damaged)
  • Filter perforation, puncture or serious damage to the heart, lungs, or inferior vena cava
  • Internal Bleeding
  • Cardiac or Pericardial Tamponade
  • Ventricle Tachycardia
  • Lower Limb DVT
  • Hematoma or Nerve Injury at the Puncture Site
  • Constant and Severe Pain in the Chest
  • Respiratory Distress
  • Infection
  • Shortness of Breath
  • Other Serious Injury and Death
• A study conducted by the New England Society for Vascular Surgery noted a 31% FRACTURE RATE in IVC filters. Most of the splinters found their way to patients’ right ventricles of the heart.
• The FDA had received almost 1,000 ADVERSE EVENT REPORTS in a five year span and issued the safety alert in 2010 to notify doctors of the risks of leaving an IVC filter implanted in a patient who no longer needed it. Of these reports:
  • 328 involved device migration
  • 146 involved detachment of device components
  • 70 involved perforation of the Inferior Vena Cava
  • 56 involved filter fracture.