What is an IVC Filter?
An IVC Filter (inferior vena cava filter) is a small wire-frame device that is implanted in the inferior vena cava, a large vein that carries deoxygenated blood into the heart.
IVC devices are designed to prevent pulmonary embolism by catching a blood clot in migration to the heart or lungs. The filter is placed by inserting the IVC through a small hole in a vein in the neck or the groin. Once implanted in the body, these filters have been known to break or fracture, causing a host of complications. Users have reported infections, vena cava perforation, organ puncture and hematoma as well as a number of additional injuries. Over 259,000 IVC filtration devices were implanted in 2012 alone. IVC devices are manufactured under numerous brand names and by different manufacturers, including:
- Bard Recovery
- Bard G2, G2 X, and G2 Express
- Bard Eclipse
- Bard Meridian
- Cook Celect IVC Filter
- Cook Gunther Tulip
IVC Filter Lawsuit Update
At the first bellwether IVC filter complications lawsuit, a Phoenix federal jury awarded a woman $3.6M for a broken vein filter, manufactured by C.R. Bard, that broke apart inside her body.
Did Bard Ignore Safety Concerns Linked to at least 27 Deaths?
Back in 2013, NBC News investigated the safety of their IVC filters and reported IVC filter complications. One former company insider says she raised questions about the device, but her complaints were dismissed.
What is a blood clot?
The human body relies on blood to carry oxygen and nutrients to all parts of itself using a network of veins and arteries. When one of these veins or arteries is damaged, blood can begin to coagulate (clot). You may be familiar with this process of clotting from a small cut. The blood thickens (clots) around the wound to form a scab that protects the vulnerable inner layers of skin. This process can also be seen in bruises (clotting of blood under the skin) as well. There are many ways a body can form blood unnecessary blood clots, such as Arterial Plaque, which can cause a potentially deadly blood clot inside an artery. Another common cause for blood clots is DVT (Deep Vein Thrombosis). DVT usually occurs in the legs and if the developing blood clot is not detected in time, it can potentially break off and travel into the heart or lungs. This is called a pulmonary embolism. IVC Filters are designed to catch a blood clot before it has the chance to migrate into the heart or lungs, thus reducing risk of pulmonary embolism.
What are the complications associated with IVC Filters?
Thousands of IVC Filter patients have reported serious complications, including:
- Venous Access Site complications
- Filter placement malposition
- Defective Filter Deployment
- Device Migration
- Filter Fracture
- IVC Perforation
- Pulmonary Embolism
- Device Infection
- Retrieval Complications
- Fracture of the IVC filter
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Hematoma or Nerve Injury at the Puncture Site
- Chest Pain
- Respiratory Distress
IVC Filters and the FDA
First generation IVC Filters were initially approved by the FDA in the late 1980’s, with “Next Gen” devices beginning their approval process in the mid 1990’s. These devices have since caused thousands of injuries in patients, prompting the FDA to issue a series of warnings outlining serious concerns about IVC Filter Device safety.
Have others been harmed by IVC FIlters?
Thousands of people have experienced some form of injury due to IVC Filter malfunction or complication.
NBC Health recently reported on the “G2 series filters”, manufactured by medical device giant C.R. Bard. The news source stated these filters are being blamed for 27 deaths due to device malfunction. It is alleged that C.R. Bard knew these devices were faulty and attempted to cover up their findings. This came just months after the manufacturer had received FDA clearance on their IVC Filter. This is not an isolated story.
There have been thousands of injuries reported to respective manufacturers of IVC Filters, as well as to the FDA. Each of these cases is individual and different, while sharing one common trait; Unsafe IVC Filters.
WPTV 5 of West Palm Beach reported on a woman’s struggle with an IVC Filter, “’Can you describe the pain at all?’” asked Contact 5 Investigator Jared Werksma.
“It’s like a knife being pushed into your stomach,” she said.
Her IVC filter had turned sideways. One of several potential problems with the devices the FDA has warned of since 2010. The story goes on to state, “I believe that there are probably at least 100,000 of those filters that were implanted in people,” said Johnson. “They have a failure rate of more than 50 percent,” The woman has since filed suit against the device manufacturer. She was quoted as saying,
“They need to take responsibility for what they’ve done.”
Bard is not alone, hundreds of additional lawsuits have been filed against IVC filter makers, seeking accountability for their products.
IVC FIlters in summary
An IVC Filter (inferior vena cava filter) is a small wire-frame device that is implanted in the inferior vena cava, a large vein that carries deoxygenated blood into the heart. IVC devices are designed to prevent pulmonary embolism by catching a blood clot in migration to the heart or lungs. The filter is placed by inserting the IVC through a small hole in a vein in the neck or the groin. Once implanted in the body, these filters have been known to break or fracture, causing a host of complications ranging from chest pain to death. First generation IVC Filters were initially approved by the FDA in the late 1980’s, with “Next Gen” devices beginning their approval process in the mid 1990’s. Thousands of people have reported injuries associated with IVC devices, prompting hundreds of lawsuits to be filed against respective manufacturers. These suits seek accountability from manufacturers, who victim’s claim, the manufacturers marketed and sold them faulty medical products. IVC Filters continue to be marketed and implanted in thousands of people each year, generating billions of dollars in revenue for their corporate producers.