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FDA Acknowledges Fatal Complications Associated with Onyx Treatment

Abnormally formed blood vessels in the brain, otherwise known as brain arteriovenous malformations (AVMs), are believed to affect approximately 300,000 Americans. Their widespread and long-lasting effects often coincide with the slow development of neurological damage over time. Symptoms such as these are severe enough to become debilitating or even life-threatening. Of increasing concern, however, is the preferred method of treatment for such complications.

The Onyx Liquid Embolic System, or simply Onyx, is intended to reduce hemorrhaging and surgical complications when patients have a brain AVM removed. However, this specific system has recently been associated with an influx of adverse incidents. According to the U.S. Food and Drug Administration (FDA), the device used to inject the Onyx liquid exhibits an increased propensity for catheter entrapment. Since Jan. 1, 2005, the FDA has received more than 100 reported cases, including nine patient deaths, of catheter breakage that may be related to catheter entrapment.

Manufactured and developed by ev3, a subsidiary of Covidien, the Onyx Liquid Embolic System was approved by the FDA on April 11, 2007. Immediately after receiving the FDA’s approval, Onyx was indicated to assist in the reduction of brain aneurysms and surgical complications following the removal of abnormally formed blood vessels. During the Onyx embolization procedure, the surgeon guides a catheter though the arterial network until the tip reaches the site of the AVM. The surgeon then introduces a substance known as Onyx liquid that will plug the fistula, correcting the abnormal pattern of blood flow.

Of significant concern to the healthcare community, however, is the recent influx of adverse events that have been reported to the FDA in regards to these procedures. Accordingly, the FDA issued a Safety Communication that acknowledged an increased risk of catheter entrapment associated with the use of Onyx. As its name suggests, catheter entrapment witness the devilry device become stuck in the implanted Onyx material.

Since Jan. 1, 2005, the FDA has received more than 100 reported cases, including nine patient deaths, of catheter breakage that may be related to catheter entrapment. The catheter was able to be removed in some of the cases. However, approximately 54 of the cases acknowledged that the device was unable to be removed, resulting in part of the catheter and the implanted Onyx material remaining implanted in the patient.

The occurrence of catheter entrapment may coincide with the development of a variety of complications that vary in severity. Those of the most serious nature include significant hemorrhaging in the brain and even death. However, reports have indicated that the Onyx plug or fragments of the entrapped catheter may migrate to other parts of the body, causing extensive damage. The migrating pieces may also be responsible for the development of unnecessary blood clots that impede the circularity system.

As a result, the FDA approved several label changes in April of this year that would address these potential concerns. It remains to be seen if the additional warnings will reduce the risk of adverse events from occurring. However, the FDA intends to conduct its own investigation into the safety and efficacy of these devices.

Do I Have an Onyx Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Onyx lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by the Onyx system, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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