The NuVasive MAGEC system was developed to help straighten the spines of children who have scoliosis using magnetic rod implants and an external remote controller (ERC) to make adjustments to those rods. Unfortunately, failures of the endcaps on these rods may have caused new damage to surrounding tissue (metal contamination, increased risk of infection, and pain) that in many cases requires unplanned surgeries to repair.
When children and adolescents are first diagnosed with scoliosis, one of the most important forms of treatment is prevention. Because scoliosis is a progressive condition in which a sideways curvature of the spine becomes more pronounced with age, slowing that progression is critical. However, medical implants for addressing this condition must be reliable and not cause further harm.
Headquartered in South Florida, the offices of Osborne & Francis have nationwide reach when it comes to defective products that are available across the United States. Reach out to our attorneys at (561) 293-2600 as soon as possible so that we can begin work on your case right away.
This is not the first time NuVasive has had to recall medical devices due to biocompatibility issues. Our attorneys have researched and handled NuVasive lawsuits before. For more information on the possible complications caused by NuVasive MAGEC devices, who qualifies to pursue a lawsuit, and previous device recalls from NuVasive, read on.
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:
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.
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:
These complications can cause pain, require surgical intervention, and could jeopardize the health of individuals who are already dealing with a delicate spinal condition.
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:
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.
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.
Qualifying eligibility circumstances for individual patients or the parents/guardians of an affected child may include:
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.
This is not the only NuVasive product that has presented biocompatibility issues. Their NuVasive Precice devices for limb lengthening or shortening procedures had enough adverse reports to warrant an FDA warning letter. Just as with the MAGEC System, this other product also involves adjustable rod implants driven by internal magnetic mechanisms. Precice devices also showed evidence of causing pain and damage to surrounding tissue and bone.
We have investigated dangerous NuVasive products before and are fully prepared to do so again on your behalf. Not only does your family deserve compensation for the injuries caused by NuVasive MAGEC rod failures, it’s also important to hold this company accountable for these defective devices. The attorneys at Osborne & Francis have proven experience with cases involving dangerous medical devices like faulty hip implants, painful vaginal mesh products, and NuVasive implants specifically.
Defective medical device and implant cases successfully handled by Osborne & Francis include:
Whether working on behalf of one or multiple individuals, your attorney from Osborne & Francis has the proven experience you need when pursuing a defective medical device lawsuit.
Metallosis, aka metal poisoning, can occur when the titanium MAGEC rods break or corrode within the body. While solid titanium implants are largely safe and non-toxic to living tissue, if metal shavings break off, they can embed in the surrounding tissue or enter the bloodstream. A buildup of titanium in the body can cause:
The long-term effects of metallosis in children could lead to later-in-life conditions and complications.
When successfully implanted and if the endcaps hold, a child shouldn’t need another surgery until after they stop growing and the rods are removed. However, if a child experiences complications due to a defective implant, they may need multiple additional surgeries to remove, replace, reposition, or clean up the area around the device.
Your child deserves better. By filing a lawsuit, you may be able to afford top-quality medical and therapeutic treatment, and possibly help prevent other children from similar harm.
In Florida, where Osborne & Francis is based, the filing deadline for defective medical device cases is four years from the date that you knew the device in question caused your injury. However, for cases that involve medical malpractice (such as provider misinformation about known risks of the device or mistakes made during surgery), those claims would need to be addressed within two years of the injury.
Minor children may have special recourse in certain circumstances, and every state’s filing limitation is different. It’s vital that you contact an experienced personal injury attorney from Osborne & Francis at (561) 293-2600 right away to make sure your injury isn’t overlooked.