BOSTON, Nov. 09, 2010 /PRNewswire-USNewswire/ -- The following was released today by the legal offices of Toriseva Law and Karon & Dalimonte LLP:
An article published by the American Medical Association Archives of Internal Medicine on November 7, 2010 (http://archinte.ama-assn.org/cgi/reprint/2010.323v1.pdf) suggests that while the G2 filter may have been approved by the FDA, there was no clinical data provided prior to approval.
Editor's note: Inferior Vena Cava (IVC) filters are used in cases where patients are at risk of pulmonary embolism (also referred to as PE, or blood clotting within the lungs) when anticoagulants cannot be used or may be deemed ineffective.
Moreover, only about 5% to 10% of adverse events are reported as part of the voluntary reporting system for adverse event reports made to the FDA. Because this system is voluntary, it is widely believed that the number of actual adverse events is much higher. Extrapolating the data, the authors of the study suggest that more than 7,000 Americans may currently have a fractured G2 filter implanted with the potential of embolization to the IVC filter. The article also notes that only 7% of the devices have been removed and that this number will likely rise over time.
In a recent safety alert, the U.S. Food and Drug Administration (FDA) urged physicians and clinicians who have implanted temporary IVC filters to consider removing them immediately after the threat of PE has passed. In some cases, the devices have been allowed to remain in the body temporarily after the symptoms of PE had disappeared. In recent years, the FDA has received 921 reports involving failure of IVC filters, 328 of which involved device migration and 146 of which caused embolizations (or detachment of the device components) as well as 70 perforations and 55 filter fractures. As a result, patients have suffered adverse clinical outcomes. The problems associated with faulty IVC filters may affect hundreds of thousands of people living in North America.
"This is a significant public health concern because of the large number of people that have been, and will be, affected with life-threatening complications from device fracture and other problems with the IVC filter," said John Dalimonte, medical device attorney and principal at Karon and Dalimonte LLP.
In a recent report by William Nicholson M.D. and researchers from York Hospital in Pennsylvania, 189 patients with an implanted Bard Recovery or the Bard G2 vena cava filter between April 2004 and January 2009 experienced complications: thirty-five patients died, 10 already had their filter removed and one person was pregnant. Eighty of these patients 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 G2 filter.
The Nicholson study found that 16 percent of the implanted filters fractured. Associated with the original recovery filter, 25 percent fractured such that one or more arms of the filter device would break off. Approximately 71 percent 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 - even sudden death.
Teresa Toriseva, a prominent medical device attorney in West Virginia, believes that patients should be informed both medically and legally.
"While patients with IVC filters implanted need advice from their doctors, they should also be aware of complications and risks associated with these devices and should consult with an attorney for an evaluation of their legal rights," she said.
About Toriseva Law and Karon & Dalimonte LLP
Toriseva Law (http://www.binary-i.net/tlaw/contact.cfm) and Karon & Dalimonte (http://www.kdlaw.net/) are among the nation's most premiere personal injury firms who advocate on behalf of victims adversely affected by medical devices and pharmaceutical products. Their objective is to inform the public about emerging device safety issues and to advocate for victims who have been harmed by such devices. The firms are respectively reviewed and rated by Martindale-Hubbell and both are members of the American Trial Lawyers Association top 100 trial lawyers. Please visit http://www.ivcfilterlawyer.com for more information.
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|SOURCE Karon & Dalimonte LLP; Toriseva Law|
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