The ALN Optional is a retrievable vena cava filter. The longer it remains implanted in a patient, the higher the risk of complications like fracture, migration, perforation of the vena cava, organ damage, and more.
Need a Texas IVC Filter Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one experienced a serious complication, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is the ALN Optional Vena Cava Filter?
ALN Optional is a cone-shaped filter that is designed to catch blood clots in the inferior vena cava (IVC) before they enter the lungs and cause a pulmonary embolism.
It is designed with six short legs and three longer, centering legs. It also has a retrieval hook to facilitate removal when the patient is no longer at risk of blood clots. The filter is manufactured the French medical device company ALN Implants Chirurgicaux.
Approval Based on Controversial IVC Filters
The ALN Optional was approved with a 510(k) application, which means it did not have to go thorough clinical trials because its design was so similar to other filters on the market.
One of those filters was the Günther Tulip® made by Cook Medical. Unfortunately, Cook is now facing about 200 lawsuits from people who say their filters were defectively designed.
The removal system for the ALN Optional is based on the Recovery Cone® made by C.R. Bard. In July 2015, the FDA sent Bard a Warning Letter for selling it without approval and failing to report a patient’s death.
What is the problem?
The FDA has issued several warnings about the risks associated with vena cava filters — especially “temporary” filters that were not removed. In August 2010, the agency reported that nearly 1,000 people had been injured by side effects. The agency warned:
“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.”
Case Reports of Serious Complications
- Annals of Vascular Disease (2014): An 83 year-old man with blood clots in his legs was implanted with an ALN filter. One year and 4 months later, a CT scan revealed that the filter had perforated the vena cava and was deeply embedded in his aorta.
- Journal of Invasive Cardiology (2010): Report describes migration of an ALN filter from the vena cava to a patient’s heart. The filter rotated upside-down (180º) and was successfully removed with surgery.
Vena Cava Filter Lawsuits Centralized in Federal Court
Hundreds of lawsuits have been filed by people who were injured by vena cava filters, but not as part of a class action. The manufacturers are accused of selling dangerous medical devices that were not adequately tested before they were marketed as safe and effective.
These cases are individual lawsuits that have been centralized in a “mass-tort” or Multi-District Litigation (MDL) in federal court. This has many of the advantages of a class action, such as improving efficiency. However, unlike a class action, individual cases remain independent.
Need an ALN IVC Filter Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas ALN IVC Filter lawyers for a free lawsuit review.