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Cases Involving Bard IVC Filter Failure Allegations Now Being Investigated by Resource4thePeople Attorneys
Date:3/28/2013

2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.

"The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation."

The FDA recommended that health care professionals responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolisms is no longer needed.

The agency also said that it is continuing to review the medical research about IVC filter problems and would issue an updated report when more information becomes available.

Consumer4thePeople is also recommending that patients who have had IVC filters implanted in their bodies actively research the FDA's Adverse Event Reports files, which are public records.

Resource4thePeople also is announcing its support for The Society of Interventional Radiology and Society for Vascular Surgery's announcement of the formation of a medical review -- PRESERVE -- to analyze the health risk of IVC filters to patients and is encouraged by the following mission statement issued by the group:

"PRESERVE data will allow a systematic, functional view, representative of all filters placed in the United States, thus, all stakeholders—individuals, health care prof
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