Bard G2 Vena Cava Filter
An inferior vena cava (IVC) filter is a metal, spider-like vascular filter that is surgically implanted into the inferior vena, which is one of two large veins that carries deoxygenated blood from the body into the right atrium of the heart.
Typically, interventional radiologists, interventional cardiologists, or vascular surgeons place IVC filters in an effort to prevent a venous blood clot, also known as a venous thromboembolism, from traveling from the lower half of the body to the heart and lungs. When blood clots travel to the heart and lungs they can cause severe injury, including a pulmonary embolism (i.e., blockage of an artery in the lung). In rare circumstances where the patient has a patent foramen ovale (PFO), blood clots can pass through the heart to the brain, causing an ischemic stroke.
IVC filters act like fishing nets and snag clots floating in the blood before they cause harm. A vena cava filter may be indicated where a patient:
- has a thrombus in a deep vein;
- cannot undergo anticoagulation therapy;
- has complications with or failure of anticoagulation therapy;
- has a pulmonary embolus removed; or
- has a recurrent embolism despite medication.
There are two types of IVC filters: permanent, and optionally retrievable. Like it sounds, a permanent IVC filter is intended to be implanted forever. Optionally retrievable IVC filters can be removed after, e.g., a patient is no longer at risk for blood clots. In many cases, an optionally retrievable IVC filter has a hook at one end that enables a physician to grasp the filter and remove it from the vein and body.
In 1979, only 2,000 IVC filters were implanted. However, current estimates reveal that more than 200,000 IVC filters are placed annually. Unfortunately, many filters intended for short-term use are being left in place long-term, which can expose patients to health risks if/when the devices fracture or fragment and embolize (i.e., clog) the vein.
As the IVC filter market is lucrative, there are a number of manufacturers, including Bard, Boston Scientific, Cook Medical, Crux Biomedical, Johnson & Johnson, ALN Implants, Rex Medical, Rafael Medical Technologies, and B. Braun. The products go by many names, such as:
- Bard G2 or Recovery IVC Filter;
- Bard Simon Nitinol Vena Cava Filter;
- B. Braun VenaTec LP Vena Cava Filter;
- Boston Scientific Greenfield Stainless Steel / Titanium Vena Cava Filter;
- Cook Medical Guenther Tulip Vena Cava Filter;
- Cordis Johnson & Johnson TRAPEASE Vena Cava Filter;
- Crux Vena Cava Filter;
- Johnson & Johnson Optease Vena Cava Filter; and
- Rafael Medical Technologies SafeFlo Vena Cava Filter.
The government considers IVC filters to be class II devices which are, generally, low risk devices that are commonly cleared for use in patients without clinical safety or efficacy data in the 510(k) approval process. In turn, dangerous products can reach the market without studies about complications associated with the placement and/or removal of a device.
In recent years, the FDA has issued safety alerts about adverse events associated with IVC filters, including:
- filter fracture;
- perforation of the IVC; and
- difficulty with removal.
On August 9, 2010, the FDA released a safety communication recommending that physicians remove the filters as soon as protection against a pulmonary embolus is no longer needed. On May 6, 2014, the FDA issued an updated safety communication about a number of potentially life-threatening complications associated with IVC filter placement and removal.
Since then, our Syracuse, New York biomedical product liability lawyers have been fielding questions from potential clients throughout the northeastern United States, including:
- How long has the Bard G2 IVC been in use?
- Is the Bard Recovery filter defective?
- How do I find out if I have a Bard G2 IVC filter?
- Do I need to have my Bard G2 IVC filter removed?
- What could happen if my Bard G2 vena cava filter is defective or breaks?
To determine if you have a claim for an injury, disability or death caused by an inferior vena cava filter, contact Bottar Leone’s product liability lawyers at 1-800-336-5297 or by email at firstname.lastname@example.org.