Children with early onset scoliosis are often prescribed a treatment in which “growing rods” are implanted in the body along the spine to help straighten out the curvature of the spine as the child grows. The treatment is difficult because, after the initial implant surgery, the child has to undergo additional surgeries about every six months to have the rods lengthened.
The Nuvasive Magec System is a device that uses magnetic technology to allow doctors to extend the rods to accommodate the child’s growth without having to perform additional surgery. The devices have worked well for some children, but for others, it has caused tissue damage, metallosis, and painful revision surgeries.
Growing-Rod Treatment Requires Multiple Surgeries
Scoliosis is an abnormal curvature of the spine that most commonly develops in children between the ages of 10-15 years old. In some cases, however, the condition develops even earlier (between infancy and the age of eight). This is called “early-onset scoliosis (EOS),” and it can be more difficult to treat because of the rapid growth children experience during this period in their lives.
Though some children can be treated with watchful waiting, braces, or casts, in more serious cases, growing-rod surgery is recommended. Doctors place metal rods on one or both sides of the spine, attached above and below the curve, to help stop the progression of the curve, and to prevent additional complications and disabilities.
Growing-rod surgery has revolutionized treatment for EOS, but it comes with its own share of difficulties. The rods have to be lengthened about every six months to accommodate the child’s growth, and that requires surgeons to perform additional surgeries under general anesthesia. Each such surgery presents risks to the child. For some children this can also result in long-term trauma as they start to dread each subsequent surgery.
The Magec System, manufactured by Nuvasive, uses magnetic technology to allow doctors to lengthen the rods in the doctor’s office without surgery. This spares the child and their family from the hardship of repeated surgeries—unless the rods don’t perform as expected.
Studies Show Nuvasive Magec System Increases Risk of Metallosis
The Nuvasive Magec System hasn’t been on the market very long. The FDA approved it in 2014, and again in 2016 with a design upgrade. There have, however, been reports of the rods fracturing, causing tissue damage, and failing to lengthen as expected. These problems require additional revision surgeries, which negates the advertised benefits of the device.
In 2017, researchers reported on five patients who had to have their devices surgically removed. A total of nine rods were analyzed. The results showed that three out of the nine rods had a fractured pin. All of the rods showed surface degradation and had considerable corrosion along the internal mechanism.
The rods themselves are made of titanium, and in some cases, the metal corrodes while it’s in the body. This can cause tissue damage and death and loosening of the rods. It may also result in rods that no longer extend as they should. The researchers concluded that most of the problems they saw were caused by corrosive debris which prevented the rods from functioning normally.
Other studies have acknowledged reports of implant failures associated with metallosis, and the FDA has received reports from patients who’ve experienced implant failure. If your child’s device didn’t perform as expected, requiring revision surgery, you may be eligible to file a Nuvasive Magec System lawsuit to recover damages.
Exclusively focused on representing plaintiffs—especially in mass tort litigation—Roopal Luhana prides herself on providing unsurpassed professional legal services in pursuit of the specific goals of her clients and their families. While she handles complex cases nationwide on behalf of consumers, Ms. Luhana resides with her family in Brooklyn, New York.