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
Since the IVC Filter was introduced in 2005, the FDA has received close to 1000 adverse reports relating to the devices.
These reports involved:
- 328 Device Migrations
- 146 Embolizations/Detachment of the Device Components
- 70 IVC Perforations
- 56 IVC Filter Fractures
FDA WARNING ON IVC FILTERS
The FDA issued a May 6, 2014 Alert concerning IVC Filters. The FDA warning to the public and doctors calls for removal of the IVC filter device as soon as the risk of pulmonary embolism is gone. The FDA has concluded that the risk of injury outweighs any potential benefit provided by allowing the IVC filter to remain implanted. Heath risks associated with IVC filters include filter fracture, device migration, perforation of the IVC, embolization, and problems removing the device. In addition, other known long-term IVC filter adverse events include IVC occlusion and lower limb deep vein thrombosis.
SERIOUS SIDE EFFECTS of IVC FILTER
- 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