If the arms on a retrievable inferior vena cava (IVC) filter fail, they can injure—or kill—their recipients.
What Are Retrievable IVC Filters?
IVC filters are designed for use in patients with pulmonary embolism (blood clots in the lungs) who cannot take anticoagulant medications. They are cage-like devices that collect blood clots and prevent them from entering the lungs.
Physicians place IVC filters in the inferior vena cava, which is the primary vein that returns blood to the heart from the lower portion of the body. When the risk of pulmonary embolism is short term, doctors often use IVC filters that are designed to be retrievable.
IVC filters have been in use for at least 30 years. In 1979 doctors implanted 2,000 of them. That number grew to 167,000 in 2007.
Retrievable IVC Filters Might Cause Life-Threatening Side Effects
In August 2010, after having received 921 adverse event reports concerning retrievable IVC filters, the U.S. Food and Drug Administration (FDA) issued a medical device safety communication expressing concern that retrievable IVC filters tend to remain in patients too long, leading to the following side effects:
- Device migration (328 reports)
- Detachment of device components (146 reports)
- Perforation (70 reports)
- Filter fracture (56 reports)
If the struts in a retrievable IVC filter break off from the main device, they can migrate into other parts of the body and perforate major blood vessels and organs. Major injuries requiring immediate medical intervention and death can result.
In September 2010, one month after the FDA issued its warning about retrievable IVCs, the Archives of Internal Medicine published an article in which three thrombosis experts gave their opinions on whether, based on patient data, 203 patients who had already received IVC filters actually needed the procedure. They agreed unanimously on 51% of the cases and could not come to a conclusion on 23%. They believed 26% of cases did not warrant IVC filter implantation. The article’s authors also found a statistically significant correlation between receiving an IVC filter and in-hospital mortality, though other factors might have contributed to the patients’ deaths.
C.R. Bard’s Retrievable IVC Filters Have Proven Problematic
Medical researchers have scrutinized two retrievable IVC filters manufactured by C.R. Bard in particular: the Bard Recovery filter (approved 2002) and the Bard G2 filter (2005). Another article in the Archives of Internal Medicine studied recipients of the two Bard devices, and the authors found that both devices had high rates of fracturing: 25% for Bard Recovery filter recipients and 12% for Bard G2 recipients. At these failure rates, an estimated 7,000 out of 62,000 Bard G2 recipients are at risk.
An editorial written by Rita Redberg and accompanying the Archives of Internal Medicine article discussed in the foregoing paragraph notes that both Bard devices received FDA approval via what’s known as the agency’s 510(k) premarket approval process, which allows medical devices that qualify as “substantially equivalent” to devices the FDA has already approved to enter the market even if they haven’t been subjected to clinical trials on humans.
In 2012, plaintiffs filed at least three class action lawsuits in Pennsylvania and California state courts against Bard to recover for side effects caused by the Bard Recovery and Bard G2 IVC filter devices. Another class action lawsuit filed in Florida state court has been removed to federal court. No multidistrict litigation over the devices is currently pending.
RLG’s Retrievable IVC Filter Lawyers Will Make Things Easier
The retrievable IVC filter lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require undue hardship. That’s why we do everything we can to streamline the process of helping you to get the compensation you deserve.
If you believe you were hurt by a retrievable IVC filter, call us or include your information on the contact form on this page. We will file a retrievable IVC filter lawsuit on your behalf if necessary.
RLG will also keep you up to date on the Bard Recovery and Bard G2 IVC filter class action lawsuits, and on additional FDA retrievable IVC filter warnings.