June 29, 2012 — The U.S. Food and Drug Administration (FDA) has issued a warning that the Onyx Liquid Embolic System has caused caused nine deaths and over 100 adverse event reports. The Onyx system is a liquid material that is used to block blood flow to abnormally formed vessels in the brain (a condition called arteriovenous malformations or AVMs). The liquid is delivered via a catheter inserted in the groin and guided to the abnormally formed blood vessels. When the liquid material comes in contact with blood, it hardens, and forms a plug.
Unfortunately, the catheter can become trapped in the hardening liquid. This can make it impossible to remove the catheter, or lead to catheter breakage. Complications include a brain hemorrhage that could cause severe injury, disability, or death.
Although the manufacturers of this device reported cases where it was difficult to remove the catheter, there were no adverse events. Therefore, the original product labeling did not include information about the risk of catheter breakage. The FDA is updating the warning label to include this risk information.
Since January 1, 2005, the FDA has received more than 100 reports of catheter breakage associated with the Onyx system. In more than half of the cases, the surgeon could not remove parts of the broken catheter, and so part of the catheter and Onyx material (plug) remained implanted in the patient’s brain.
The problem is that the catheter and the plug are not intended to be long-term implants. Patients may require additional medical treatment if the material begins causing serious complications, including hemorrhage. The catheter fragment could also migrate to different parts of the brain or body. Furthermore, patients may need to take blood-thinning medications to reduce the risk that blood clots will form around the pieces of the broken catheter. Radiation exposure from multiple MRIs could also increase the long-term risk of certain types of cancers.
The FDA has already updated the label on the Onyx system to warn of the potential risks. They are now advising doctors to be prepared for an emergency situation in which the catheter breaks and becomes trapped in the patient’s brain. The procedure should only be performed in facilities that are staffed and prepared to handle such an emergency.
Do I have an Onyx Liquid Embolic System Lawsuit?
The Schmidt Firm, PLLC is currently accepting Onyx Liquid Embolic System induced injury cases in all 50 states. If you or somebody you know has been injured by an Onyx Liquid Embolic System, 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.
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