Concerns prompt FDA to issue additional safety alert
The FDA issued a “Safety Communication” May 6, 2014 regarding the potential for harm to patients from a small, cage-like medical device implanted in blood veins. The device, the Interior Vena Cava (IVC) filter, is used in patients at risk of developing blood clots or embolisms anywhere in the body, but especially in their legs (which is called deep vein thrombosis). The filter device is an option for patients who cannot take blood thinners. Blood clots and embolisms can travel to heart, lungs, and other organs, causing serious damage or death.
Though the Interior Vena Cava (IVC) filter is designed to prevent injury or death from clots and embolisms, it is now being investigated for a number of potentially life-threatening side effects. According to additional research and postmarket studies that updates a 2010 FDA Safety Communication on the device, the Interior Vena Cava (IVC) filter can damage the blood vein by:
- moving/migrating
- becoming stuck, sometimes inside the heart
- broken device fragments
- device puncturing the vein or surrounding tissue
If I hadn’t felt the pain, I never would have known that the filter was causing the trouble, and ultimately the final diagnosis would have been that the last two prongs would have punctured my small intestine or my aorta and I would have died instantly
The filters have also been reported to puncture hearts and lungs. One patient died following a study of the devices; the FDA safety communication indicates the research showed problems with the device tended to increase the longer it was implanted in the patient or, in cases where it was used temporarily, during the removal process.
If you or someone you know experiences any of these symptoms, contact your healthcare professional immediately for evaluation and possible treatment:
- Difficulty breathing, shortness of breath
- Heart/chest discomfort or pain/palpitations
- Dizziness
- Fainting
- Or other symptoms you do not expect
The medical device injury attorneys at Harman Law are investigating the IVC’s that are used in patients nationwide
Two models of IVC filters mentioned in the article “Vena Cava Fractures Not Uncommon” in MedPage today are:
- Bard Recover (on the market 2003-2005 but may still be in some patients)
- Bard G2 (still on the market, introduced as a device that resolved the problems with the Bard Recover)
Other brands of IVC’s include:
- ALN
- Argon
- Braun
- Cook
- Cordis
- Mobin-Uddin
- Rafael
- Volcano
This blog post will be updated with new information as it becomes available.
Harman Law LLC represents clients across the country who have been injured by dangerous and defective drugs and medical devices.
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