The ALN Optional is a temporary vena cava filter that is designed to protect patients from blood clots. The longer it remains implanted, the higher the risk of complications. The FDA has received reports of ALN filters rotating and perforating internal organs, resulting in serious complications.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently evaluating IVC filter cases in all 50 states, regardless of whether you have been injured or not. If you or somebody you know was implanted with an IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the ALN Optional Filter?
The ALN Optional is a retrievable filter that is implanted in the inferior vena cava (IVC) to catch blood clots traveling from the lower half of the body before they enter the lungs and cause a pulmonary embolism.
It is manufactured by the French company ALN Implants Chirurgicaux and was developed in 1999. The FDA approved a new design with a retrieval hookin 2008. The ALN is designed with six short legs to achieve fixation and three longer legs for centering.
What is the problem?
Temporary vena cava filters should be removed as soon as a patient is no longer at risk of a pulmonary embolism — between 29 and 54 days after implantation, the FDA recommends.
Unfortunately, studies estimate that only 30-50% of retrievable filters are ever removed. This is a problem because temporary filters have never been studied for long-term safety. The longer they remain implanted, the higher the risk of complications, such as:
- Filter fracture
- Perforation through the wall of the vena cava
- Internal bleeding
- Organ damage, perforation, or laceration of the heart and lungs
- Embolization of broken filter pieces in the bloodstream
- Filter gets clogged with clots and blocks blood circulation
- Broken pieces may be impossible to remove
ALN Optional Linked to Serious Complications
In August 2010, the FDA issued a Safety Communication to warn patients about these risks. A number of case reports have also specifically linked the ALN Optional with complications:
- Annals of Vascular Disease (2014): ALN Optional implanted in an 83 year-old man with deep vein thrombosis (DVT). Over a year later, doctors discovered that the filter was deeply embedded in his aorta after perforating the vena cava.
- Journal of Invasive Cardiology (2010): ALN filter migrated to a patient’s heart and rotated upside-down (180º), but it was still removed successfully.
Was Approval Based on Dangerous Filters?
The manufacturer used a 510(k) application to gain approval for the ALN Optional filter. This type of application allows new devices on the market without requiring new clinical trials — as long as the device is “equivalent” to another device on the market.
Unfortunately, the ALN Optional is “equivalent” to some controversial products. One of these was the the Cook Medical Günther Tulip®. As of January 2016, approximately 200 lawsuits have been filed against Cook Medical by people who were injured by their filters.
The approval also included equivalence to the C.R. Bard Recovery Cone® Removal System. The FDA issued a warning letter to Bard in July 2015 for selling the system without approval and misclassifying a patient death as a “malfunction.”
ALN IVC Filter Lawsuits
If you were injured by an IVC filter, you are not alone. Hundreds of lawsuits have already been filed against device-makers like C.R. Bard and Cook Medical for failing to warn about serious risks. These lawsuits are not part of a class action. Instead, they are centralized at the federal level in a Multi-District Litigation (MDL).
Do I have an IVC Filter Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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