Endologix, Inc. Recall: Frequently Asked Questions
According to the United States Food and Drug Administration, Endologix, Inc. has issued a recall of more than 60,000 medical devices. Specifically, the medical device manufacturer has recalled its AFX Endovascular AAA System, or AFX for short.
What was the AFX used to treat?
The AFX Endovascular AAA System was used to treat abdominal aortic aneurysms. This type of aneurysm develops when the aorta gets thinner and thinner, eventually causing it to swell and expand. The AFX System is a thin tube made of a polymer. The tube contains a metal stent as well. Once placed into the aorta, the blood should flow through the AFX System, as opposed to the aorta itself. This should prevent the aneurysm from growing and potentially rupturing, which could lead to serious complications or death. The AFX was inserted during a procedure called an endovascular aneurysm repair.
What is the problem with the AFX?
After Endologix, Inc. released the AFX system to the public, the FDA began receiving reports of complications. Many reports stated that the patients suffered from Type IIIa and IIIb endoleaks. Type III endoleaks occur when blood continues to flow into the aneurysm, as opposed to the implanted device. Therefore, the risk of rupture remains and may even increase.
Does my doctor know if my device is defective?
In July of 2018, Endologix, Inc. sent a letter titled “Urgent: Important Safety Update” to physicians, advising them of the risks associated with the AFX. If your physician implanted one of these devices, your physician should have alerted you about the recall. Your physician should also be able to look at your medical records to see if one of the recalled devices was implanted.
Will I be entitled to compensation if I received a faulty medical device?
Whether a patient is entitled to compensation depends on a number of factors. Generally, the injured patient must show that the product was defective, the product was being used as anticipated or as directed, the defective nature of the product was the direct cause of the patient’s injuries, and the patient suffered injuries. Experienced medical device injury attorneys will submit evidence of each of these elements. If one of the factors cannot be supported, the claim will fail.
What are the types of compensation available to injured patients in a medical device injury claim?
 In a medical device injury claim, the types of damages may include:
- Healthcare costs incurred as a result of the faulty device
- Lost wages
- Pain and suffering
- Emotional distress
- The cost of installing wheelchair ramps or other accommodations in the patient’s residence
- The cost of future medical care that may be necessary
- If the patient died, surviving family members may claim funeral and burial expenses. They may also claim the deceased’s estimated future earnings.
With the assistance of an experienced medical device injury attorney, all avenues of recovery will be explored to ensure the maximum amount of compensation available under the law is obtained.
Do I have to go to court?
It is unlikely that you will go to court in your medical device claim. Your attorney is usually able to handle hearings on your behalf, and most of these claims settle long before trial. However, if your claim must go to trial, your attorney will thoroughly prepare you for your testimony.
If you were injured by the Endologix AFX System, call Parker Waichman LLP
At Parker Waichman LLP, our defective medical device attorneys hold medical device manufacturers accountable for their faulty products. To schedule a free consultation, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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