IVC filters, short for Inferior Vena Cava filters, are cone-shaped and have legs that extend to intercept and trap blood cloths. 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.
FDA WARNS OF ADVERSE EVENTS WITH LONG TERM USE
Reports first surfaced in 2005 that the radial arms and struts of medical equipment manufacturer Bard’s Recovery IVC Filter had broken off inside the body of patients. Since that time the U.S. Food and Drug Administration (FDA) has received around 1000 adverse reports involving the filters, primarily regarding the IVC filters fragmenting and embolizing inside the body.
Due to these reports, made by both physicians and patients, and extensive research of the filters, the FDA urged physicians to consider the risks before recommending the IVC Filter be installed in patients who are ineligible for anticoagulation therapy. The FDA also recommends that the filters be removed as soon as the risk of Pulmonary Embolism has passed.
Despite the FDA’s warning, Bard’s redesigned IVC Filter has been implanted in more than 65,000 patients.
IVC FILTERS LINKED TO HIGH RATE OF FRACTURES AND MIGRATION
SERIOUS SIDE EFFECTS OF IVS FILTER:
- Heart and Lung perforation
- Fracture of the IVC Filter
- IVC Filter Migration
- Perforation, Puncture or Serious Damage to the Heart, Lungs or 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 Heart, Chest or Elsewhere in the Body
- Pulmonary Embolism
- Respiratory Distress
- Shortness of Breath
- Other Serious Injury and Death