Patients suffering from a continuous threat of developing pulmonary embolism have been offered an IVC (inferior vena cava) filter option if they showed contraindications for traditional anticoagulation therapy. This blood clots therapy is known to prevent pulmonary embolism in many patients.
However, since the Bard IVC filter was first introduced in 2005, the Food & Drug Administration (FDA) have received thousands of adverse reports on its use. The vast majority of reported issues involved fragmenting and migration. Complications with the IVC filter are life threatening and extremely serious.
Just after its initial launch, manufacturers of the Bard IVC recovery filter attempted to modify the device when its radial arms and struts were reported to a broken off inside the veins of patients. Since its redesign, tens of thousands of patients have received the filter, often referred to as the G2 IVC device.
A study printed in the Archives of Internal Medicine indicated that the Bard IVC (inferior vena cava) filter have been used on patients unqualified or unresponsive to traditional anticoagulant drugs. The occurrence rate of fractures and embolization on both the Recovery filter and G2 filter was so common and high that many medical facilities halted implantation of the device. However, many patients are still suffering from its failure.Updated Study On Correlation Between Blood Clots & IVC Filters
In March 2014, an updated study linking IVC filter use and potential risks of lung blood clots (pulmonary embolism) was published by the Journal of the American College of Cardiology. The study claims higher potential risks of recurrent VTE (venus thromboembolism).
While less than two percent of all patients with an IVC filter experience a pulmonary embolism compared to approximately 5 percent for any non-filtered patient, recurrent venous thromboembolism occurs at a rate of over six percent for IVC filter patients.
Deep vein thrombosis (DVT) also known as venus thromboembolism, is a serious disease that forms blood clots in the lower legs. If the clot dislodges and begins to travel, it can move into the lungs and cause pulmonary embolism. This serious condition can produce long-term complications including disabilities, organ damage, PTS (post-thrombotic syndrome) and death.The IVC Filter Device
The vena cava filter is a tiny device designed as a cone shape with long legs extending through the vein in an effort to catch blood clots. When the device’s legs break into pieces, or the filter in its entirety migrates in the bloodstream, it affects a variety of other body parts. The migration can perforate a vein or cause sudden death.
After the results of this intense study were released, the Food and Drug Administration issued a nationwide warning to doctors. The warning recommended monitoring patients implanted with the device, so the filters could be removed once any potential of blood clots had passed. Today, many lawsuits have been filed as a result of sudden death and other extensive medical problems caused by the filter.
Originally, the Bard IVC filter was designed and implanted for long-term use. However, that recommendation by the manufacturer has been rescinded. The FDA also recommends physicians advise their patients of all potential risks of implantation to ensure the device is removed once the danger of clots no longer exists.Typical IVC Filter Complications
Just inches long, the IVC filter resembles a tiny umbrella skein. However, because each leg of the device is thin and malleable, it easily breaks off and migrates to vital organs including the lungs and heart. Common complications of the IVC filter include:
- Filter fracturing
- Punctures, perforations and significant damage to the lungs, heart or vena cava
- Pericardial or cardiac tamponade
- Internal bleeding
- Lower limb DVT (deep vein thrombosis)
- Ventricular tachycardia
- Pulmonary embolism
- Severe constant pain in the chest, heart or other locations throughout the body
- Life-threatening infections
A federal court class-action lawsuit was originally filed in September 2012 against the manufacturers of the Bard Recovery and G2 IVC filter devices. Since then, lawsuits have been filed in Florida, Pennsylvania, Illinois, California and other courts in the nation. Each suit involves a series of allegations that the manufacturer knew, or at a minimum should have known, the potentially life-threatening side effects their products produce.
The lawsuits claim that the company failed to provide adequate warning of the serious side effects, and should be held financially accountable. Seasoned attorneys are protecting the rights of victims of injury or death caused by the Bard IVC filter to ensure fair and adequate compensation for their loss, suffering, pain and damages.Get A Free Case Review of Your Bard IVC Filter Complication Case Now!
Rosenfeld Injury Lawyers at (888) 424-5757 provide a free initial consultation to evaluate a case involving Bard IVC filter migration to determine the merits of filing a claim or lawsuit. Any individual suffering injury and pain may be entitled to receive financial recompense due to any medical issue caused by the vena cava filter.
For additional information about our IVC filter complication practice see the pages below: