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C.R. Bard has manufactured several types of inferior vena cava filters (IVC filters) for over ten years, but since 2005, the Food and Drug Administration (FDA) has received nearly 1,000 reports of dangerous and life-threatening side effects from IVC filters. This has resulted in the Bard Eclipse filter recall which was done to protect and inform patients of the risks the IVC filter holds.
For patients who develop blood clots in their legs, or are at risk of developing blood clots in their legs, doctors might insert an IVC filter to catch any blood clots traveling toward the heart or lungs. IVC filters are cone-shaped with thin wire legs called struts, designed for removal after the threat of the blood clot has passed.
Bard’s Eclipse IVC Filter was released onto the market in 2010, the same year the FDA issued a warning regarding the reports of adverse events from IVC filters with recommendations on the length of time the medical devices should remain in the patient. The Eclipse IVC filter is nearly identical to one of Bard’s previous IVC filters, the G2, however the Eclipse has an electropolished finish.
Concerns over the safety of IVC filters have existed for years, but a study published in 2012 found that several of Bard’s IVC filters had high rates of fracture (12%) and embolization (13%) in patients. Once an IVC filter has failed, removal becomes much more difficult, and only half of the patients in the study were able to have fractured components of the filter successfully removed.
All IVC filters come with a risk of device failure; however, that risk greatly increases with the amount of time the device remains inside the body. While it is not always easy to determine if an IVC filter has failed without the use of medical scanning equipment, some of the most common warning signs include:
Medical device manufacturers like Bard have a responsibility to adequately warn doctors and patients of all risks associated with a device. However, with such a high rate of failure, patients believe Bard did not properly warn them of the dangers associated with its IVC Filters.
If you suffered complications after the implantation of an Eclipse IVC filter, you may be able to obtain compensation. The IVC filter lawsuit attorneys at Raizner Slania have the experienced needed to take on medical device manufacturers like C.R. Bard. Contact us today for a free consultation to discuss your claim.