Bard Ivc Filter
Bard ivc Filter Side Effects
- Filter fracture
- Device migration (if the device shift position, it may erode into the body or become ineffective at blocking blood clots)
- Perforation of the heart, lungs, kidneys, or blood vessels
- Erosion, narrowing, obstruction and/or slower blood flow into the inferior vena cava (IVC)
- Blood clots clogging the IVC
- Bleeding or fluid build-up around the heart (hemorrhagic pericardial effusion)
- Embolization of broken filter fragments
- Lower-limb Deep Vein Thrombosis (DVT), edema (swelling with fluid)
- Cardiac tamponade (excess fluid around the heart compresses the heart and inhibits pumping)
- Hemorrhagic pericardial effusion (excess fluid around the heart)
- A doctor may be unable to remove the IVC filter
- Irregular heartbeat
- Additional surgery
Out of the 921 reported events to the FDA, there were:
- 328 device migrations
- 146 involved embolizations or detachment of the device components
- 70 IVC perforations
- 56 IVC filter fractures
After reports that the radial arms and struts of the Bard Recovery IVC filter had broken off inside the body of patients in 2005, Bard attempted to modify this filter to correct this deadly defect. The redesigned filter is the G2 IVC filter and has since been implanted in more than 65,000 patients. According to reports posted on line, the November 8 print issue of theArchives of Internal Medicine, an archive journal of JAMA, is expected to publish a study conducted by William Nicholson M.D. and researchers from York Hospital in Pennsylvania concerning the safety of the implantation of Bard’s Peripheral Vascular Recovery and the G2 vena cava filters. Specifically, the researchers examined the rate of complications after implantation of these IVC filters. Nicholson and his colleagues evaluated 189 patients with an implanted Bard Recovery or the Bard G2 vena cava filter between April 2004 and January 2009. Among this group, 35 patients died, 10 already had their filter removed and one person was pregnant. Eighty of these patients study underwent fluoroscopy to assess the integrity of the filter. Patients who experienced any kind of fragmentation of the filter underwent echocardiography and cardiac CT. Out of the 80 patients, 52 had the Bard redesigned G2 filter.
The Nicholson study found that 16 percent of the implanted filters fractured. Associated with the original recovery filter, 25% fractured such that one or more arms of the filter device would break off. Approximately 71% of the fragmented pieces would migrate through the veins of the patient to the heart, presenting life threatening symptoms such as rapid heartbeat and fluid buildup, including sudden death.
Despite the actions taken by Bard to redesign the original Recovery filter, the study has shown that 12 percent of the patients that had the G2 filter still experienced filter fractures. The average time the patients in the study had the implants was 50 months with the Recovery filter and 24 months with the G2 filter.
Bard recovery Filter Problems and Complications
The Bard Recovery Filter is a medical device created by C.R. Bard, Inc. and approved by FDA in 2002 to prevent blood clots from traveling through the body and causing a pulmonary embolism.
The device is implanted in individuals at risk for a pulmonary embolism, who are unable to take an anticoagulant or if such medications have failed. The Bard Recovery is designed so that the IVC filter can be removed or retrieved from the body after the threat of a pulmonary embolism has passed.
A pulmonary embolism is the sudden blockage of an artery which brings blood into the lungs. Typically, this blood clot does not form in the lung artery, but somewhere else in the body. If a clot breaks off it can travel through the blood stream and get lodged near the lung causing a pulmonary embolism.
The Recovery Bard IVC Filter is designed to stop or catch blood clots travelling through the inferior vena cava in its 12 “struts” or legs. The Bard Recovery legs consist of six short struts that are positioned over six longer struts.
The device is constructed of Nitinol (Nickle Titanium Naval Ordance Laboratory), which contains shape memory. However, shortly after the device was introduced, reports of Bard Recovery filter problems and complications were reported.
The struts or legs of Bard Recovery flters are prone to fracture and then migrate to other locations in the body, particularly the heart or lungs where they could cause severe and potentially life-threatening injury. Symptoms of problems with a Bard IVC filter could include chest pain and shortness of breath. This often results in emergency medical treatment, where a cardiac catheterization or CT scan may be done to see whether the IVC filter fractured or migrated.
A number of medical studies have indicated that the Bard Recovery failure rate is between 21% and 31.7%:
- A 2005 study by the New England Society for Vascular Surgery found a 31.7% Bard Recovery fracture rate after examining adverse event reports filed with the FDA.
- A 2008 study in the Journal of Vascular and Interventional Radiology indicated a 21% Bard Recovery failure rate among patients included in the study.
- A 2010 study in the Archives of Internal Medicine found that the rate of complications with Bard Recovery IVC filters was 25%, with researchers finding that pieces of the Bard Recovery Filter migrated to the heart in more than 70% of those who experienced a fracture.
Bard G2 Filter Problems and Complications
The Bard G2 IVC Filter System is a medical device created by C.R. Bard and approved by FDA in 2005. It was introduced as a successor or replacement for the Bard Recovery IVC Filter system, which was associated with a high number of fractures and other problems that occurred when the retrievable filter was left in place for extended periods of time.
Bard marketed the G2 IVC filter as having “enhanced fracture resistance”, “improved centering” and “increased migration resistance.” Unfortunately, the Bard G2 IVC filter has also been linked to a high rate of fractures and migrations.
According to an August 2010 study published in the Archives of Internal Medicine, the Bard G2 IVC filter fracture rate was 12%. In some of the cases, fractured pieces of the Bard G2 filter migrated to the hepatic vein or the lung. Researchers concluded that the incidence of Bard IVC filter fractures was proportional to the length of time that the retrievable device was left in place. Therefore, the rate of Bard G2 filter problems and complications may increase as time passes.
The Bard G2 IVC filter is designed to stop or catch blood clots travelling through the inferior vena cava, to prevent a pulmonary embolism. They are implanted in patients at risk for a pulmonary embolism, who are unable to take a medication to reduce the risk of blood clots or if such anticoagulants have failed.
When the Bard G2 IVC filter is left in place after the risk of a pulmonary embolism has passed, the legs or struts that extend out in a spider-like fashion may fracture or break. This could allow the pieces of the filter to travel through the bloodstream and get lodged in other parts of the body, usually the heart or lungs.
Symptoms of problems from a Bard G2 filter fracture or migration may result in severe and persistent chest pain and shortness of breath. This often results in emergency medical treatment to determine whether the symptoms are a heart attack or fracture of the IVC filter.
Bard G2 Filter Lawyers & Bard Recovery Filter Lawyers
Despite information that indicated consumers faced an unreasonable risk of injury or death from Bard G2 and Recovery IVC filters, the manufacturer failed to take adequate steps to protect consumers or warn about the risks.
Thousands of individuals have been implanted with the Bard G2 and Recovery filter, exposing them to a risk of serious and potentially life-threatening injury if the Bard IVC filter fracture, migrate or fail. As a result of Bard’s failure to inform or warn physicians or the public, individuals who received one of these IVC filters may be entitled to financial compensation through a Bard IVC Filter lawsuit.
The Bard G2 and Recovery filter attorneys at Heninger Garrison Davis LLC are providing free consultations and claim evaluations to all individuals who received an IVC filter since 2003, who suspect that they may have experienced problems from a fractured Bard Recovery or G2 filter. All cases are pursued on a contingency fee basis, which means that there are no fees or expenses to hire our Bard Recovery filter attorneys unless we win your case.