NuVasive MAGEC Lawsuit
Mounting evidence suggests NuVasive MAGEC scoliosis treatment may be associated with complications, including metallosis.
Scoliosis is an abnormal sideways curvature of the spine that afflicts roughly 3 out of every 100 people in the United States, according to the National Scoliosis Foundation. While treatment can often involve frequent surgeries and complications, a new type of treatment known as NuVasive MAGEC System has been touted as a safer and less invasive option for scoliosis.
Unfortunately, mounting evidence reveals that the NuVasive MAGEC System has been linked to reports of metallosis and device failures that may require complicated revision surgery to repair.
What is Early Onset Scoliosis?
Early onset scoliosis (EOS) is a type of scoliosis that develops before the age of 10. It is also known as infantile scoliosis and juvenile scoliosis.
The causes for early onset scoliosis are often varied or unknown.
According to the British Scoliosis Society, common symptoms of early onset scoliosis include:
- Uneven waistline
- Tilted shoulders
- Waist sticking out
- Clothes not fitting the same
- Difference in hip height
- Rib cage protruding to one side
- Overall appearance of leaning
- Pain associated with physical changes
When symptoms are spotted, a physician will order tests to determine whether early onset scoliosis is the culprit. These tests may involve imaging technology, MRIs, CT scans, and bone scans.
Treatment Methods of Early-Onset Scoliosis
Treating EOS in a timely matter is important. If left untreated, severe cases of scoliosis can worsen over time, potentially impairing heart and lung function as the body becomes misaligned.
For treatment, there is typically a four-tier process, according to the Scoliosis Research Society.
Observation: Children with EOS are monitored with regular visits to a physician and testing as they grow. If the spine’s curvature is mild and does not worsen, intervention may not be necessary.
Bracing: Some patients will benefit from a back brace. The brace is worn for the vast majority of the day and is often successful in halting the worsening of scoliosis. Modern technology has made braces lighter and more effective.
Casting: In cases with children younger than 3 years old, body casting may be recommended. A body cast is placed around the child’s chest and abdomen after manipulation under general anesthesia and has the potential to fully straighten the spine.
Surgery: For the most severe cases, surgery may be required. One of the most common surgical methods involves growing rods. A rod is implanted in the child and helps guide the spine to grow straight. The rods are lengthened during surgery roughly every six months, according to the Children’s Hospital of Philadelphia.
NuVasive MAGEC Scoliosis Treatment
Implanting growing rods in a child is not only a complicated procedure but also requires repeated surgeries that can result in further complications. So, when the U.S. Food and Drug Administration (FDA) approved a design called the NuVasive MAGEC (MAGnetic Expansion Control) System, patients were excited.
The new treatment method uses adjustable growing rods that can lengthen remotely using magnetic technology. In an ideal scenario, one surgery is undertaken to implant the rod and another is done to remove it when the child stops growing. This ultimately reduces the number of repetitive follow-up surgeries needed to lengthen standard rods.
As a result of fewer follow-up surgeries, NuVasive claims that “MAGEC helps reduce associated complication risks from repetitive surgeries, and simplifies the care and journey of an EOS patient.”
NuVasive MAGEC Rod Disadvantages
Although the MAGEC System was touted as a safer and less invasive alternative to other scoliosis treatment methods involving rods, mounting evidence points to substantial complication rates in patients treated with the system.
Researchers have collected clinical data on magnet driven growth rods over the past four years. One report published in the World Journal of Orthopedics in 2017 concluded that the magnet rods showed promise but that the verdict is still out on whether MAGEC is safer than traditional growth rods.
While the early returns have been promising, scientists are wary about the complication rates. In one scientific article published in the European Spine Journal in 2017, researchers noted the “substantial complication rate” of magnet driven growing rods.
MAGEC Rod Complications
One of the biggest complications associated with the MAGEC System is metallosis, a medical condition caused by metal debris entering the tissue and blood. The condition is most commonly associated with metal-on-metal implants, but scientists suspect the metal components in the magnet driven rods of MAGEC may also cause particles to seep into the tissue.
In one of the most recent studies published in Spine in 2018, researchers noted that the complexity of expandable rods means they may be more likely to succumb to failures. After analyzing 34 MAGEC rods from 18 children, they found titanium wear debris inside all of the implant rods. This type of wear could result in metal particles being released into the surrounding tissue.
A group of scientists also issued a note of caution in 2017, saying that “there have been recent reports identifying implant failures that may be associated with significant metallosis surrounding the implants.”
Metallosis can result in inflammation, pain, and swelling in the surrounding tissue. This not only causes discomfort but may even lead to premature failure of MAGEC rods.
Any failure of MAGEC rods, including a device fracture or unexpected wear, could necessitate revision surgery. This creates more potential for unforeseen complications and goes against the claims made by the MAGEC System’s makers.