Many patients who suffered from deep vein thrombosis (DVT) in their legs were having inferior vena cava filters, also known as IVC filters, placed in the inferior vena cava to prevent blood clots that break off from traveling to the heart, lungs and brain.
There are two types of filters: permanent and retrievable, which means the filter is removed after the risk of emboli resolves. While most IVC filters currently on the market are the permanent type, the retrievable models appear to be the ones associated with the most complications.
Both C.R. Bard’s IVC Filter and the G2 Filter System received approval for sale by the U.S. Food and Drug Administration’s (FDA) 510(k) protocols. This type of approval allows for clearance of a device without human clinical trials if a device maker can prove it is substantially equivalent to another product already approved for sale and on the market. Although C.R. Bard removed the Recovery IVC from the market in 2005, it is believed that there are still devices implanted in patients. The G2, which replaced the Recovery, is still being used today.
Retrievable IVC filters have been linked to reports of fracturing and migration. In most cases, the fractured portions of the device migrate to the heart and lungs of patients. However, fragments of IVC filters can also migrate to other organs. Unfortunately, once the metal fragments from a retrievable IVC filter have deposited in the heart, lungs or other organ, serious injury, bleeding, excruciating pain, future embolus, as well as other complications, can occur.
In August 2010, the FDA issued an advisory after receiving 921 adverse event reports involving IVC filters.
IVC filters are medical devices that are implanted in the inferior vena cava in order to filter blood clots that travel from the lower portions of the body to the heart and lungs. These clots are called deep vein thrombosis, also called DVT. If they travel to the lungs, they can form a life threatening pulmonary embolism. IVC filters were initially marketed to remain in the body for a finite period of time and therefore marketed as retrievable.
In August 2011, the FDA received a personal injury report of a patient requiring hospitalization due to the breakage of an implanted Bard inferior vena cava (IVC) filter. (It was a G2 IVC filter). According to the report, the fracture of the IVC arm was found on a CT scan. The incident, which is not isolated, came after an FDA-issued warning in August 2010, citing problems with retrievable IVC filters, including hematomas.
In a study published in 2010 Annals of Vascular Surgery, migration/tilt was higher in Bard filters compared to other filters.
IVC filters are small, spider-like devices, which are surgically inserted into the inferior vena cava to prevent blood clots from reaching the lungs. However, these devices can suffer from fatigue, causing them to fail and fracture, winding up migrating through the body, causing potentially life-threatening damage.
The reported problems with the Bard IVC filters include a high rate of perforation of the vena cava resulting in perforation of the surrounding tissue, intestines, spine, vertebrae and arteries.
Warning signs that a Recovery IVC Filter or G2 IVC Filter System has failed include chest pain and shortness of breath. In most cases, victims end up in the emergency room. A CT scan or other test will be used to determine if the IVC filter system has failed.
The failure of the Recovery IVC Filter or G2 Filter System can lead to serious and life-threatening complications. These include: pulmonary embolus, severe and constant pain in the chest, heart or other parts of the body, respiratory distress, tissue perforation of tissue, vessels and organs, hemorrhage, as well as constant anxiety or worry over the fact that metal shards are in the organs.
If you or a loved one were injured as a result of a defective Recovery IVC Filter or G2 IVC Filter System, you may be entitled to compensation. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).