Which MAGEC Devices Have Been Recalled?
The U.S. Food and Drug Administration (FDA) reports that NuVasive issued a recall of various spinal implants in February of 2020. The company also put a global shipping hold on these devices due to biocompatibility issues in April of 2021 (which it later lifted in July of 2021 for one marginally improved device design, detailed below).
The following implants have been recalled, and need to be regularly monitored in case of failure:
- MAGEC Spinal Bracing and Distraction System
- MAGEC 2 Spinal Bracing and Distraction System
- MAGEC System
- MAGEC System Model X device
- MAGEC System Model X rod
- MAGEC System Rods
The issue with these products is endcap separation, which can lead to corrosion of the rods. This degradation of the implant can then cause metal contamination of the surrounding tissue and bloodstream, and pain due to the instability of the compromised implant. It makes continued magnetic therapy ineffective, and often requires an unplanned surgery to remove, repair, or replace the device. This can cause pain to your child, cost money from your family, and interrupt the daily enjoyment of life, school functions, and quality time.
The only product available to U.S. patients that has been modified to address the endcap separation problem is the MAGEC X rod (MAGEC 2b). However, the label on this device also includes information about the potential health risks related to these rods.
The FDA states that it continues to receive reports of problems related to endcap separation, even after the rod redesign. They recommend that any individual experiencing unexpected back pain after device implantation should seek a doctor’s advice. Your physician may order an X-ray scan to evaluate the integrity of the device and the best available treatment options.
Medical product liability is a complex area of law that requires knowledgeable counsel. The successful verdicts and settlements achieved by Osborne and Francis include multi-million dollar medical device implant victories for hip and surgical mesh cases (see FAQs for specific case details).
What Complications Arise From MAGEC Rods?
The main reason for the above recalls is the issue of endcap separation, which NuVasive’s urgent product recall claims “occurred in approximately 0.5%” of cases.” However, even without the defective device, a 4-year follow-up study on magnetic controlled growing rods for early-onset scoliosis found that 75% of the patients monitored needed to undergo revision surgery after rod implantation.
A similar 3-year study also found that there were 13 implant-related complications in 6 out of 18 patients monitored. A device from NuVasive that can essentially fall apart greatly increases the already-present risk of complications from magnetic rod spinal implants.
The clinical impact of NuVasive MAGEC device failures could include:
- Hastened degeneration of the internal components of the device, which means it may no longer function properly to prevent scoliosis curvature
- Toxic release of titanium alloy debris into surrounding tissues, which could cause metallosis (aka metal poisoning)
- Loosening, fracturing, corroding, and migrating of the metallic implants
These complications can cause pain, require surgical intervention, and could jeopardize the health of individuals who are already dealing with a delicate spinal condition.
If you or your child were injured by a NuVasive MAGEC device, you may be able to hold them legally and financially accountable for the harm done.
Why Are People Filing Lawsuits Against NuVasive MAGEC Rods?
The pain, damage, time, stress, and cost associated with a defective Nuvasive MAGEC Rod implant can be overwhelming. These issues affect the patient as well as their family and loved ones. Medical complications can interrupt preventative scoliosis treatments, and potentially worsen the condition or cause new injuries.
People are filing lawsuits against NuVasive because a settlement or successful verdict can help cover:
- Medical bills related to pain management, removal surgery, and any other resulting issues due to device failure
- Lost wages for the patient or their caretakers, like sick and vacation time used for recovery, advancement opportunities missed, or unemployment due to the complications
- Pain and suffering hardships, including both physical and psychological symptoms
These lawsuits also help incentivize companies like NuVasive to implement higher safety standards for their products. The more corporations are held accountable for their mistakes, the less likely they are to release new medical products before thoroughly investigating the potential risks.
Increased Risk of Psychological Harm for Children and Adolescents
According to the Scoliosis Reduction Center, children and adolescents with scoliosis are 40% more likely to experience suicidal thoughts. A scoliosis diagnosis already comes with fears and anxiety about abnormal body development. These worries place increased strain on your child’s friendships and relationships with peers.
Young scoliosis patients are already vulnerable to severe emotional stress, and unnecessary surgical complications could exacerbate all of those issues. An experienced lawyer will know how to translate real psychological harm into language and figures that can be understood in court.
When a person consents to have a medical device implanted in their body, its sole purpose is to improve their health or well-being. If that device fails, the consequences should not be left for the patient to bear alone. The least that NuVasive can do is take responsibility for the damage done, and the procedures that are required to prevent further harm.
Who Qualifies to File a Lawsuit?
Qualifying eligibility circumstances for individual patients or the parents/guardians of an affected child may include:
- Anyone who received one of the recalled MAGEC system spine implants
- Those who received a NuVasive MAGEC device implant on or after September 1, 2014
- Individuals who received a NuVasive MAGEC device implant before the age of 10 and suffered later complications
The age of the patient at the time of implantation is relevant because there are filing deadlines (known as “statutes of limitations”) in each state regarding personal injury and product liability. These rules are sometimes modified based on age, so that injured children can take legal action once they’re old enough to do so.
There may also be exceptions to these time limits based on when your symptoms first became noticeable, when you were notified about the device recall, or if you were misled about the dangers of the device before implantation. If you are unsure about any of these requirements, contact a lawyer for guidance about your legal options.
If you miss your window of opportunity to file a lawsuit before a statute of limitations deadline arrives, you may never be able to access the compensation you’re entitled to under the law. Time may be running out, so do not hesitate — contact Osborne and Francis right away at (561) 293-2600.
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