Frequently Asked Questions (FAQ) and answers about the NuVasive MAGEC System®, a magnetic rod for children with scoliosis that is linked to severe side effects.
UPDATE: 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. Click here to read more.
What is scoliosis?
Scoliosis is an abnormal curve to the spine that can worsen as a child grows. When the curve reaches 50º (as measured by an X-ray), doctors generally recommend surgery. If the spine curves more than 50º, there may not be enough room in the chest cavity for their heart, lungs, and other vital organs to grow. This can lead to serious health problems later in life, including problems that can shorten the lifespan.
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. To prevent the scoliosis from getting worse, EOS requires frequent treatments to straighten the spine as the child grows. The child may also need to wear a brace.
What is the MAGEC System?
The MAGnetic Expansion Control (MAGEC) System is a new treatment for children with severe early-onset scoliosis. It was created by NuVasive, Inc., a medical device company in San Diego, California.
How does the MAGEC System work?
The MAGEC System uses non-invasive magnets and a remote-control to extend the titanium rods in a doctor’s office, without surgery. The child is implanted with 2 titanium rods that slide along a guide-rail.
To lengthen the MAGEC rods, a doctor holds the remote-control against the child’s back. Each click of the remote-control activates the magnet and expands the rod 3-7 millimeters at a time. Some children feel pain as the rods are lengthened, but others feel nothing at all.
What is the difference?
In comparison, traditional “growing rods” require surgery every 3-6 months to extend the rod as the child’s spine grows. The surgery involves an incision to open up the child’s back, manually extending the rod by loosening a screw with a screwdriver, expanding the rod, tightening the screw, and closing the incision with stitches. Surgery requires hospitalization for 12-24 hours and days of painful recovery.
How many MAGEC surgeries are necessary?
Surgeons perform the same surgery to attach the MAGEC rods to the child’s spine as they do with traditional “growing rods.” Unless the child experiences complications of the MAGEC rods, they will not need another surgery until they stop growing. Then the MAGEC rods are removed and the child undergoes a final, permanent spinal fusion.
What are the benefits?
- Fewer surgeries: MAGEC patients undergo significantly fewer surgical procedures than traditional “growing rod” patients — but they may need unplanned surgery if something goes wrong, like a rod that fails to extend.
- Less anesthesia: Anesthesia (pain-numbing medication) can cause serious side effects, including brain damage and death. Children who receive the MAGEC System do not need anesthesia when the rods are magnetically extended.
- Less infection risk: Fewer surgeries throughout treatment for scoliosis reduces the patient’s risk of developing infections.
What is the problem?
Magnetically-controlled growing rods have a lower rate of infections than traditional “growing rods,” but they do not completely avoid the need for repeated surgeries, as advertised by NuVasive. This is because some children experience problems with the MAGEC rods.
Furthermore, studies have also found that MAGEC rods significantly increase the risk of metallosis (metal poisoning) or defective metal parts, resulting in unplanned surgeries to replace the MAGEC System. Titanium metallosis could also have permanent long-term side effects.
What are the risks?
- 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
What is metallosis?
Metallosis (metal poisoning) is a serious complication of the MAGEC System. It can occur when titanium rods corrode or break. It can also occur when the metal-on-metal parts grind together and tiny particles of titanium shave off and accumulate in tissues or the bloodstream.
What are the long-term side effects of metallosis?
As titanium metal particles accumulate around the implant, the child can develop tissue damage (necrosis), inflammation, pain, and swelling. This increases the risk that the child will need surgery to remove the MAGEC rods and replace them with traditional rods.
No one knows the long-term side effects of metallosis in children, but high levels of metal in the bloodstream could potentially cause systemic reactions all over the body. The risks of metallosis include:
- Vision and hearing problems
- Cognitive impairment
- Nerve damage
- Heart failure
- Thyroid problems
- Skin rashes
- Unknown long-term effects in children
What studies have investigated MAGEC System complications?
In one recent study, 34 children with the MAGEC System all had significant titanium metallosis around the implant. Furthermore, 53% of the rods had “O-ring seal failure.” The O-ring is supposed to prevent titanium from being released into the body.
“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.”