NuVasive MAGEC Side Effects
NuVasive MAGEC system side effects include pain, tissue death around the implant, inflammation, metallosis and device failure. Some studies estimate up to 57% of patients may suffer from side effects. Biocompatibility issues may cause tissue reactions in devices where the endcap separates from rods.
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MAGEC Rod Complications
Across studies MAGEC rod complication rates vary with anywhere from 18% to 57% of patients suffering complications. Some patients who suffered complications such as device failure, had to undergo revision surgery to replace the faulty rods.
MAGEC rods are effective at treating pediatric scoliosis, but nearly half of the patients suffered complications, according to a 2019 study published in Asian Spine Journal.
Another 2016 study in The Spine Journal concluded, “Medium-term results of [magnetic controlled growing rods] are not as promising as previously reported early results. Hence, MCGRs should be used with caution.”
In February 2020, NuVasive recalled devices because endcaps were separating from rods. In July 2020, the Food and Drug Administration cleared a redesigned rod, the MAGEC Model X rod, and it’s currently the only device available in the United States.
- Implant Failure. Implant failure occurs when it loosens, fractures, corrodes or migrates in the body. Fractured rods may damage nearby tissues or structures.
- Mechanical Component Failure. Rod endcaps may separate.
- Pain. Pain may occur when implants fail. Pain may also occur when rods are adjusted.
- Distraction Failure. The rods may not move when being adjusted. They may also fail to stay at the proper setting in between distractions (adjustments).
- Biocompatibility Concerns. When the endcaps come off rods, the body is exposed to internal components of the rods, which may or may not be compatible with the body and cause reactions.
- Metallosis. Because MAGEC rods are made of titanium they can release microscopic metal particles into surrounding tissues. These particles may cause tissue death and device loosening.
- Unplanned Revision Surgeries. When complications occur, surgeons may have to perform revision surgeries to remove and replace MAGEC rods.
Metallosis and biocompatibility issues are two of the more serious complications because they can lead to the need for surgery. Lawyers are currently accepting MAGEC system lawsuits on behalf of patients who suffered these and other serious complications.
What is Metallosis?
Metallosis, sometimes called metal poisoning, is one of the most common complications cited in MAGEC system studies. Metallosis occurs when metal implant parts release microscopic metal particles into the surrounding tissues and blood because of device wear. It can occur anywhere from weeks to years after metal device implantation.
“MAGEC rods are associated with tissue metallosis in the majority of cases…Until the implications of metal debris in children are known, we urge caution with the use of this implant.” — Rushton, P.R.P. et al. ”
Metal debris causes tissue around the implant to die. Symptoms include: pain, tissue damage, inflammatory reactions, neurologic symptoms and device loosening, which requires surgery to correct.
Researchers have found titanium debris in the tissues surrounding MAGEC rods during revision surgery.
Biocompatibility Complications
Biocompatibility is a term used to describe how a material reacts with living tissue. Medical device makers typically perform testing to make sure the material doesn’t react poorly with tissue.
In April 2021, NuVasive raised concerns that separated MAGEC system endcaps could expose surrounding tissues to materials that NuVasive did not originally test for biocompatibility.
When an implant isn’t biocompatible, it can cause tissue reactions. These can include discoloration and inflammation, which may require implant removal.
In January 2021, the FDA received reports of local tissue reactions that could be connected to endcap separations. The agency is currently working with NuVasive to evaluate biocompatibility testing results for MAGEC rods.
Recommendations for MAGEC Patients With Side Effects
According to the FDA, patients who aren’t having problems with functioning MAGEC rods don’t have to remove them for two years after implantation. These devices are only cleared to stay in the body for two years.
Children who experience back pain or other problems should speak to their medical providers. Providers should examine the patient and take x-rays to check on the MAGEC implant.
The FDA recommends parents or caregivers report device problems through the FDA’s MedWatch Voluntary Reporting Form.
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