IVC Filters Lawsuits
On August 9, 2010, the FDA reported on adverse events involving IVC filters, including device migration, embolization (detachment of device components), perforations, fractures, and death.
The Dangers of IVC Filters
IVC filters are small, cage-like devices that are inserted into the inferior vena cava ("IVC") to capture blood clots and prevent them from reaching the lungs. IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective.
In a five year span, the FDA received almost 1,000 adverse event reports. Of these reports,
- 328 involved device migration,
- 146 involved detachment of device components,
- 70 involved perforation of the Inferior Vena Cava, and
- 56 involved filter fracture.
Because of these adverse event reports, a safety alert was issued notifying doctors that there was significant risk to patients if an IVC filter was left implanted after a patient no longer needed it.
In addition, a study conducted by the New England Society for Vascular Surgery, found a 31% fracture rate in IVC filters and most of the splinters found their way to the right ventricle of patients' hearts.
IVC Filter Side Effects
Serious Complications from IVC Filters can include:
- Occlusion (blockage/closing of a blood vessel or hollow organ)
- 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
- Recurrent blood clots
- Internal Bleeding/Hemorrhaging
- 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
- Shortness of Breath
- Other Serious Injury and Death