IVC Blood Clot Filter Side Effects Continue to Cause Injury Years After Warnings First Issued
For the past five years, the product liability lawyers at Saiontz & Kirk, P.A. have been representing clients throughout the U.S. who are pursuing an IVC blood clot filter lawsuit after suffering serious side effects when one of these devices implanted to reduce the risk of pulmonary embolism fractured or moved out of position. Even after several FDA warnings, individuals continue to suffer injuries from some of these defectively designed filters.
Inferior Vena Cava (IVC) filters, also known as blood clot filters, are small, spider-like devices implanted into the vena cava to prevent blood clots from traveling to the lungs. Despite concerns about the safety of IVC filters and questions about their effectiveness, amid continued marketing by the manufacturers, many people have had these devices implanted into their vena cava and suffered serious injuries.
In recent years, most IVC filters implanted have been designed to be retrievable, allowing the surgeon to remove the device once the risk of a blood clot has passed. However, due to inadequate warnings provided by many manufacturers, the devices are often kept in place much longer than necessary, increasing the risk of serious injury.
Some of the common IVC blood clot filter side effects that have been reported after the devices failed include:
- Fracture or Migration of the IVC Filter
- Perforation of the Heart, Lung, Vena Cava or Other Tissue
- Cardiac or Pericardial Tamponade
- Ventrical Tachycardia
- Persistent Chest Pain or Shortness of Breath
IVC Filter Warnings
The FDA has issued a series of warnings about the risks associated with IVC blood clot filters, with the first safety communication issued by the agency in August 2010.
At that time, the agency warned that between 2005 and August 2010, more than 921 adverse event reports were filed with the FDA involving IVC filter problems, including: 328 reports involving IVC Filter migration; 146 reports involving IVC Filter embolization or detachment of device components; 70 reports involving vena cava perforation; and 56 reports of IVC Filter fractures
The FDA’s IVC filter blood clot warnings issued in August 2010 highlighted an emerging trend:
IVC filter usage has increased rapidly during the past thirty years. In 1979, 2,000 IVC filters were used, while in 2007, almost 167,000 filters were implanted, and the market for IVC filters is only expected to increase, with an estimated 259,000 IVC filters to be deployed in 2012…
…The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE [pulmonary embolism] subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
As manufacturers have continued to promote many of these devices without adequate warnings or instructions in recent years, a growing number of doctors have continued to implant IVC filters for blood clot risks.
In May 2014, the FDA issued another safety communication to healthcare providers, once again stressing the importance of removing blood clot filters as soon as they are no longer needed.
As the agency noted at the time (emphasis added):
The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC and difficulty removing the device…
… For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.
IVC Filter Safety and Effectiveness Questions
In addition to concerns over the risk of side effects following blood clot filter placements, many experts have raised questions about the effectiveness of retrievable IVC filters at reducing the risk of pulmonary embolism. Several studies have indicated that the devices are widely overused and suggest that many patients may fare no better with an IVC filter vs blood thinner use to prevent a clot from traveling to the lungs.
In September 2010, a study published in the Archives of Internal Medicine found that nearly half of all surgeries to implant blood clot filters may not be necessary. After reviewing data on more than 1,500 at risk of a blood clot traveling to the lungs, researchers found that only 51% of those who had an IVC filter implanted were an appropriate use.
In March 2013, two studies and an editorial were published in the medical journal JAMA Internal Medicine, indicating that there is not only a lack of evidence establishing the effectiveness of inferior vena cava (IVC) filters, but that the lack of data has led to a lack of consensus on how the implants should be used.
Earlier this year, in April 2015, another study published in the Journal of the American Medical Association (JAMA) raised questions about the benefits of blood clot filters over use of anticoagulants. French researchers found that patients who received an IVC filter may be twice as likely to suffer a pulmonary embolism than those who were prescribed blood thinners along, and the side effects are often fatal. Out of about 200 patients who received an IVC filter, at least six suffered a recurrent pulmonary embolism within three months, and another three patients experienced side effects where the IVC blood clot filter broke off and traveled to the lungs or heart.
Blood Clot Filter Lawsuits
Unfortunately, these IVC filter warnings and studies come after thousands of individuals have experienced problems from blood clot filters. While some have called for an IVC filter recall to be issued, it appears that many of these injuries may have been avoided if the manufacturers of certain devices had provided better warnings and instructions.
The blood clot filter attorneys at Saiontz & Kirk, P.A. are reviewing potential cases for individuals who have received certain types of devices, including:
- Bard G2 Blood Clot Filter Lawsuits
- Bard Recovery Blood Clot Filter Lawsuits
- Cook Celect and Gunther Tulip Filter Lawsuits
Free consultations and case evaluations are provided to help individuals throughout the U.S. determine whether an injury suffered by themselves or a loved one may have been caused by side effects of the blood clot filter implanted into their IVC. All cases are reviewed under a contingency fee agreement, which means there are no attorney fees or expenses unless a blood clot filter settlement or recovery is obtained in the case.
PHOTO COURTESY OF: BozMo via Wikimedia CC