Each year, over 600,000 people suffer a pulmonary embolism, where a blood clot formed in the leg breaks loose and travels to the lungs. More than 60,000 die, most within 30 to 60 minutes after symptoms start. Common treatment options begin with oral and injectable anticoagulant medications, also known as blood thinners, and end with
the inferior vena cava (IVC) filter.
IVC filters have been in use since the late 1960s, with a marked increase in use beginning in the late 1990s with the development of removable IVC filters.
What is an IVC Filter?
An IVC filter is a tiny metal device that can be described as cage-like or spider-like, which is implanted in the inferior vena cava, the artery that returns blood from the legs to the heart. The design of the IVC filter allows it to catch blood clots before they can travel toward the lungs. It is used as a last resort treatment for individuals who cannot take anticoagulant medications or those who are taking anticoagulants and still develop clots.
Approved by FDA Without Testing
Removable IVC filters have been approved by the FDA through their 510(k) clearance process. This process allows manufacturers to bypass the process of conducting new safety studies if their new device is similar to another device already on the market. This means that new designs of existing devices are not subject to rigorous testing to prove safety before being used by the medical community.
The Dangers of IVC Filters
IVC filters can fragment and migrate throughout the body, with potentially fatal outcomes if the fragments migrate into the heart, lungs, or other vital organs. By 2010, the FDA had issued a cautionary bulletin to doctors, following over 900 reports of adverse events involving IVC filters.
Failure of IVC filters can include:
- Device fracture and fragmentation
- Device migration
- Embolization to heart or lungs
- Perforations of blood vessels
Symptoms of IVC Filter Failure
IVC filters come in two designs - permanent and removable. Removable IVC filters are designed for retrieval once the blood clot issue has resolved, but design flaws and fragmentation can render these filters impossible to remove. Individuals with a removable IVC filter that has fragmented and/or migrated are at an increased risk for severe complications, chronic pain, and even death.
Symptoms of IVC filter failure can include but are not limited to:
- Rapid heartbeat
- Blood around the heart
- Difficulty breathing
- Vomiting blood
- Intermittent abdominal or back pain
- Gastric pain
Have you or a family member been injured by an ICV filter?
The manufacturers of IVC filters have repeatedly failed to warn the public about the potential risks associated with their devices. If you or a family member have suffered serious side effects from the use of an IVC filter, you may be entitled to compensation. Filters designed and produced by Bard Medical, Cook Medical, and Boston Scientific in particular have produced a high rate of failure for their devices. If you know or suspect that a faulty IVC filter was used to treat a blood clot issue in you or a family member, contact the Gerling Firm. An attorney experienced in medical products liability can help you understand your legal rights.
Contact Gerling for a free case evaluation today.