NuVasive Inc. sells the MAGEC System, a magnetic titanium rod for the treatment of young children with severe scoliosis. Unfortunately, the MAGEC System rods may fail to lengthen, break, cause metallosis, or need unplanned revision surgery.
Need a Texas MAGEC System Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or your child were injured or needed surgery for a defective MAGEC System, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: MAGEC System Linked to Tissue Incompatibility Problems
In July 2021, the FDA issued a Safety Warning after receiving reports of patients who suffered from tissue incompatibility (biocompatibility) problems with NuVasive MAGEC implants. The warning involves the following NuVasive MAGEC devices:
- 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
MAGEC Rods Release Titanium and Metal
January 2018 — A new study of the MAGEC Rod System for children with early-onset scoliosis has found that it “significantly releases titanium and possibly aluminum,” and also releases the metal vanadium.
What is Early-Onset Scoliosis?
Early-Onset Scoliosis (EOS) is a severe curvature of the spine that is diagnosed in children under 10 years old. Left untreated, the spine can curve so much that it compresses the chest cavity and causes life-threatening heart and lung problems — or even premature death.
Young children with severe scoliosis usually require surgery to implant titanium rods that straighten the spine. Traditionally, the child would need to undergo multiple painful, invasive, risky surgeries to remove and replace the titanium rods with longer rods as their spine grows.
What is the NuVasive MAGEC System?
NuVasive Inc., a medical device company based in San Diego, California, created the MAGEC® System — a new treatment for children with scoliosis. Unlike traditional “growing rods,” which require surgery every 3-6 months to mechanically lengthen the rod, the MAGEC System uses non-invasive magnets to lengthen the rod.
How Does it Work?
The MAGEC System uses a powerful magnet to expand the rod by sliding along guide-rails. Every 6 months, the child visits a doctor to have the MAGEC rod lengthened in a “short, non-invasive procedure that takes place in a doctor’s office,” according to advertisements from the Children’s Hospital of Philadelphia.
Unlike traditional “growing rods,” NuVasive claims that the MAGEC System eliminates the need for multiple invasive surgeries, as well as the life-threatening risks associated with surgery. When the child has stopped growing, the MAGEC rod is removed and the child undergoes one last surgery — a spinal fusion to permanently cure their scoliosis.
NuVasive MAGEC System Failures
There are many reports of MAGEC Systems causing severe problems in children. Experts are currently studying the long-term side effects of the MAGEC System. The following complications have been reported:
- Metallosis (metal poisoning in the blood)
- Broken rods
- Rods failing to lengthen or expand
- Rods bending or separating
- Drive pin fracture
- O-ring seal failure
- Anchor failure
- Fractured pin used to stabilize the rod
- Loose hardware
- Revision surgery
MAGEC System Metallosis (Metal Poisoning)
One of the most serious problems is metal poisoning (metallosis) from the MAGEC System. It occurs when the metal-on-metal parts grind together, corrode, break, or wear out prematurely, releasing tiny particles of titanium into the patient’s soft tissues or their bloodstream.
Long-Term Risks of Metallosis
Children with metallosis from the NuVasive MAGEC System may suffer pain, inflammation, swelling, soft-tissue growths called “pseudo-tumors,” necrosis (tissue death), skin discoloration, or need an unplanned revision surgery to remove the MAGEC System.
The long-term side effects of metal poisoning in children are unknown, but may include:
- Vision and hearing problems
- Cognitive impairment
- Nerve damage
- Heart failure
- Thyroid problems
- Skin rashes
- Unknown long-term effects in children
What’s the problem?
If a NuVasive MAGEC System rod breaks, bends, fractures, or does not extend, it will probably need to be removed surgically and replaced with another device.
If the MAGEC System corrodes — or if the metal-on-metal parts grind together — it may cause metallosis (metallosis). This increases the risk of complete failure of the implant, as well as other long-term side effects that will require ongoing medical treatment.
Studies of MAGEC System Metallosis
In a study of 34 children with the MAGEC System, all 34 had evidence of significant metal debris around the implant.
In 53% of the patients, doctors discovered an O-ring seal failure. The Normally, the O-ring seal prevents metal particles from being released into the patient’s body.
Furthermore, failure of the O-ring seal is a risk-factor for metallosis, according to a warning from the researchers:
“The combination of high volumes of titanium wear debris alongside O-ring seal damage likely accounts for the metallosis reported clinically around some MAGEC rods.”
In December 2016, another study found that “metallosis was found during revision in 4 out of 5 patients.” The researchers recommended careful follow-up of patients who have received the MAGEC System, warning that the study highlights concerns with tissue metallosis.
MAGEC System — Unplanned Revision Surgery
NuVasive and many children’s hospitals advertise the NuVasive System as “less surgery for kids with severe scoliosis” — but studies show that many children who get the MAGEC System need surgery.
In one study by the San Diego Spine Foundation, 10 out of 23 children (43%) who received the MAGEC System between 2014 and 2016 required an unplanned revision surgery due to severe complications.
The The Spine Journal also published a study in which 6 out of 8 children (75%) with the MAGEC System needed an unplanned revision surgery — 2 because their rods broke, 1 because the rod drive pin broke, and 1 because the rod failed to lengthen.
Need a MAGEC System Lawyer in Texas?
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