Many plaintiffs who filed a federal lawsuit allege that the NuVasive MAGEC System, a new device to treat children scoliosis, are defective products linked to complications such as bone fractures, metallosis and revision surgery. The magnetically-controlled growing rod system is, in fact, prone to breakage inside the
kids’ bodies, despite the company marketed it as a product intended to reduce the risk of surgical
reinterventions.
If one of your kids suffered any serious damage after being implanted with NuVasive’s device, you may be
eligible to pursue a lawsuit and claim a large compensation for damages.
What is the NuVasive MAGEC System?
The NuVasive MAGEC System is a relatively new device used to treat Early Onset Scoliosis (EOS) and
prevent Thoracic Insufficiency Syndrome in children aged 3 to 10. It is manufactured by NuVasive Inc. a
medical device company headquartered in San Diego, California. In September 2017, the corporation
received approval to market their products from the U.S. Food and Drug Administration (FDA), thanks to the
infamous Premarket Notification [510(k)] Fast Track Program.
What is Scoliosis and how it is treated?
Scoliosis is a common condition that affects 2-3 percent of the population, and develops in infancy or early
childhood. It is usually diagnosed when the kid is 10-15 years old, but when it occurs in younger children, it
may have severe life-long consequences and must be treated surgically.
EOS and other severe forms of this condition require multiple interventions to correct the spinal curvature
of the child as he or she grows. During the procedure, a titanium rod is implanted along the spine to help
control its abnormal curvature and assist the growth of the chest cavity. These rods preserve the mobility
of the spine to prevent spinal fusions which may require additional procedures during the adolescence.
However, these rods need to be lengthened (distracted) or replaced as the spine keeps growing. After the
initial implanting, the child must undergo several re-intervention procedures roughly every 6 months.
How does the NuVasive MAGEC System work?
According to NuVasive’s claims, the MAGEC rod is designed to eliminate the need for multiple surgeries.
The magnetic rods are, in fact, implanted on two guide-rails where they slide freely, so they can be
lengthened from the outside using a powerful remote-controlled magnet. No revision surgeries are
required, since the whole procedure is completely non-invasive and can take place in a doctor’s office.
Eventually, when the child has stopped growing, the titanium rods can be safely removed.
Why is the NuVasive MAGEC System dangerous?
Despite the manufacturer’s claims about its safety and convenience, several studies noted how often the
children who were implanted with the MAGEC System had to face serious and often crippling
complications.
Researchers even found out that 6 out of 8 children who received the allegedly innovative device
eventually required as many revision surgeries as if they had been implanted with a standard one. In one
study, the results were particularly alarming. In all the 34 patients (100 percent) examined, doctors found wear debris inside the titanium rods, especially towards the magnet end. This debris could be released into
the surrounding tissues, causing a devastating toxic reaction known as metallosis, that could lead to
excruciating pain, permanent vision damage, necrosis (tissue death) and even pseudo-tumors.
The corroded actuator’s pins often broke as the device is probably defective, causing an increased risk of
bone fractures and unplanned revision surgeries.
Why should you file a lawsuit today?
Whenever a company releases defective products to the market, it is ultimately responsible for all the
damage caused by its numerous failures. NuVasive widely promoted its magnetic device as an innovative
and safe solution to standard scoliosis treatment, yet they never warned the public about its significant
dangers. If your family had to face all the struggles of dealing with the suffering of a child, you have all the
rights to file a lawsuit and seek proper compensation.
If your claim is valid, you may be eligible for a monetary reward. Let us help you fight this battle and get the
justice you deserve by calling us today.