Defective IVC Filters
Buffalo Defective Medical Device Attorneys
Inferior vena cava (IVC) filters are designed to filter or stop blood clots from traveling from the lower portion of the body to the heart and lungs. They are implanted in the IVC, which is the main vessel that returns blood from the lower half of the body to the heart. They first came on the market in the 1960s for permanent use in patients who are at risk of a deep vein thrombosis (DVT) or pulmonary embolism (PE) and who could not manage that risk with medication.
In the early 2000s, companies like C.R. Bard, Inc., Cook Medical and Boston Scientific sought and received FDA approval to market retrievable IVC filters to prevent PE when anticoagulant therapy is contraindicated or has failed.
In addition to the approved uses, doctors began to use these devices to prevent PE/DVT in trauma patients and in patients having certain surgeries, such as bariatric procedures. Bard and other IVC filter manufacturers maintain that the filters can remain in the IVC permanently, but they can also be retrieved if desired.
Adverse Events Associated with IVC Filters
The FDA has issued safety warnings regarding IVC filters due to the number of adverse events associated with the device, including migration of the IVC filters, fracture of the filters, and perforation of the IVC.
On August 9, 2010, the FDA issued a Safety Communication, warning healthcare providers to remove the filter as soon as the protection from PE is no longer needed to minimize chances of an adverse event occurring.
On May 6, 2014, the FDA issued an updated Safety Communication for physicians who implant IVC filters and clinicians responsible for ongoing care of patients with these devices.
The FDA's summary of the problems associated with these devices includes:
- Device migration
- Filter fracture
- Embolization (movement of filter or fractured fragments to the heart and lungs)
- Perforation of the ivc
- Difficulty with removal
Another risk associated with long-term use of IVC filters is lower limb DVT and IVC occlusion.
A decision analysis conducted by the FDA and published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders found that if the patient's risk for PE has passed, removal is favored between 29 and 54 days following implantation. In addition to its decisional analysis, the FDA is requiring IVC manufacturers to participate in the PRESERVE study or conduct their own post-market surveillance. The data gathered from these studies will help the FDA and manufacturers assess the use and safety profile of IVC filters.
If you believe you or someone you know may have suffered a serious injury from an IVC filter complication, contact us for a free legal consultation today. Our Buffalo defective medical device attorneys can help you understand your options and guide you through the legal process.
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