Injury Lawsuits, filed on the behalf of patients who have sustained injuries in conjunction with the defective inferior vena cava (IVC) filter are being investigated by Sheller, P.C.
Moreover, an NBC News Investigation is raising serious questions about the Recovery blood-clot filter – a medical device implanted in thousands of Americans at risk for blood clots.
In the first of two reports by NBC News, it was revealed that the device was linked to at least 27 deaths and some 300 other non-fatal problems that have also been linked to the Recovery, sold by C.R. Bard. The second report raises serious questions about how the device received clearance and suggests that a signature on the application may have been forged.
An IVC filter is a small medical device implanted deep inside the body to prevent blood clots before they enter the lungs and cause a pulmonary embolism. However, when temporary filters are not removed, patients are at risk for life-threatening consequences.
Did Forged Documents Push the Device to Market?
C.R. Bard, in 2002, recruited Kay Fuller, a veteran regulatory specialist with the intent to secure FDA clearance for Recovery, after a prior application was turned down by the agency.
In the interview with NBC News, Fuller said she had serious issues about the Recovery. But, upon voicing her opinions, Bard officials weren’t interested.
“Fuller says she told her boss she would not sign the application until the issues were resolved. Bard submitted its application to the FDA with what appears to be Fuller’s signature on it.”
Defective IVC Filters
The filters are used when patients can’t use blood thinners and other methods. It was only recent that IVC filters were not permanent. In fact, in an effort to reduce the risk of serious complications, some patients will have the IVC filter removed once the risk of the blood clot traveling to the lungs and/or heart is gone. INVC filters such as the Bard Recovery filter, among others, are implanted into the inferior vena cava (IVC) to limit where blood clots can travel within the body. However, several studies have found that shards can break from these filters and can be as deadly as a stroke.
New England Society for Vascular Surgery conducted a study that found a 31% fracture rate in IVC filters. Most splinters traveled to the patients’ right ventricles of the heart. While another study by Dr. Nicholson of York Hospital, found that 25% of the group had splinters that broke off and most migrated to an organ such as the lungs or heart. A newer study joined Cook Medical’s Celect IVC filter with a 43% rate of vena cava perforation, compare to a zero percent rate for the Option filter by Rex Medical.
Injuries Associated with IVC Filters
Patients whose filters fracture with the bod are at risk for severe injuries if the fractured pieces migrate to the lungs or heart and include:
- Pulmonary Embolism
- Compromised respiration and more
If you or someone you love has had complications with an IVC Filter, it is important to seek medical attention immediately if they experience any unexplained chest and/or heart pain.
Sheller, P.C. medical device attorneys will continue investigating injuries and death associated with the IVC Blood Filters and are available to discuss your legal options if you have been affected by the device. Call 800-883-2299 or fill out the inquiry form.