NuVasive Magec System: What We Know About Magnetic Growing Rod Safety

NuVasive Magec System: What We Know About Magnetic Growing Rod Safety 2017-12-08T08:47:45-05:00

An international group of researchers have raised concerns about a revolutionary technology for the treatment of severe scoliosis in young children:

  • NuVasive Magec System Growing Rods
  • Linked to metallosis, premature implant failure
  • Our attorneys have opened a full investigation

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Early-onset scoliosis is diagnosed in children under the age of 10, according to the Scoliosis Research Society. At this point, patients have not yet reached skeletal maturity; their spines, in short, will continue to grow. Continued abnormal growth, however, can have consequences. After all, other internal organs need space to grow. But an abnormal curvature in the spine can crowd out these developing organs, including the lungs and the heart. To avert long-term damage, physicians have to correct the spine’s curvature.

Scoliosis Treatments For Young Children

The Cobb Angle is the primary measure of success and failure in scoliosis treatment. First described by Dr. John Cobb in 1948, this measure of the spine’s curvature has been employed for generations to evaluate the effects of therapy.

Cervical X-Ray

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A Cobb angle of at least 10° is sufficient for a diagnosis of scoliosis, but the children who receive Magec growing rods normally have far more severe deformities. Most researchers, including the experts at the Scoliosis Research Society’s Growing Spine Committee, believe that, when diagnosed in a young child, Cobb angles larger than 35° are likely to worsen if left untreated.

That’s when more-serious treatment methods are indicated. And while the vast majority of children will be fitted for plaster casts or braces first, severe deformities often require surgical intervention. Though several surgical methods are currently in use, the next step in treating severe early-onset scoliosis is usually growing rods.

Traditional Growing Rods Come With A Major Downside

Traditionally, surgeons implant one or two rods alongside the spine, to brace the skeletal structure and guide its development. As the child continues to develop, doctors have to operate periodically, manually lengthening the rods to correct the spinal curvature and accommodate further physical growth.

Traditional growing rods can result in significant decreases in the Cobb angle, and should thus be considered an effective scoliosis treatment. But there’s one major downside.

To work correctly, the average child will need to undergo a new lengthening procedure every 6 to 8 months, Boston Children’s Hospital reports. In extreme cases, a single patient can endure 20 or more surgical procedures within the course of treatment.

Magnetic Rods For Scoliosis: The Perfect Solution?

The Magec System, first developed and manufactured by Ellipse Technologies, was created to solve the problem. The invention relies on sophisticated magnet technology.

Each Magec growing rod features a magnet at the center. After being implanted, the rod’s magnet can be activated from the outside, through the use of an external remote controller. A physician locates the magnet, then switches on the remote control, allowing the rod to be lengthened without any surgical intervention.

Can Magec Save Children From Invasive Procedures?

It sounds, for all intents and purposes, like the perfect solution. By allowing for non-surgical distractions, the Magec System promises to save children and their families time, pain, stress and (over the course of treatment) even money.

Though Magec growing rods are far more expensive than traditional implants (about 23-times more expensive), they should actually turn out to be a more cost-effective option in the long-run, orthopedic surgeons at the University of Minnesota have found.

Over Time, Magnetic Scoliosis Rods May Save Money

Cutting down on invasive procedures has a huge impact on a family’s health care costs, the researchers say. The average cost of a Magec lengthening session, the analysts continue, is about 35-times less expensive than a traditional growing rod operation. Over the course of a six-year treatment period, that makes Magec a cheaper method.

National health regulators saw these potential benefits and acted. The Magec System was granted clearance for sale in the European Union on November 17, 2009. A little fewer than five years later, the implant technology gained clearance for US sale from the Food & Drug Administration, according to Shriners Hospitals for Children.

The invention is now sold and marketed under the brand name NuVasive, a company based in San Diego, California.

How Common Are Magec Growing Rods?

Only available at a select group of the nation’s best children’s hospitals, like the Children’s Hospital of Philadelphia and the Cleveland Clinic, Magec growing rods haven’t yet come into general use. We don’t really know how many children in the United States have received the implants, since NuVasive doesn’t release public statistics.

In the United Kingdom, around 125 patients are treated using the Magec System every year, researchers at the Royal Victoria Infirmary say. In a sense, Magec growing rods are still an experimental treatment, with researchers around the globe investigating their efficacy and safety.

Is Magec An Effective Therapy For Early-Onset Scoliosis?

Early results have been mixed.

A number of sources have reported significant improvements in scoliosis, according to authors in a 2017 article for the World Journal of Orthopedics. That’s probably why the United Kingdom’s National Institute for Health and Care Excellence recommended the Magec System as an alternative to traditional growing rods in a 2014 position paper, noting the technology’s cost-saving potential and “gentler” approach to severe cases of scoliosis.

Studies Note “Substantial Complication Rates”

But another group of researchers have come to more worrisome conclusions. In a number of recent studies, surgeons around the world have linked Magec growing rods to “substantial complication rates.”

The medical literature now features multiple reports of premature implant failure, in which a rod broke inside a patient or became useless after the fracture of a key component. Reports of metallosis, a potential reaction to the device’s titanium alloy, have also surfaced in case reviews.

Some analysts even put these two potential risks together, saying that side effects of metallosis may increase the likelihood of an implant failure. Beyond discomfort, pain and anxiety, the reported complications could also increase the risk for an invasive revision procedure, something the Magec System was meant to eliminate.

Metallosis: Causes, Symptoms & Complications

Magec growing rods are constructed from a titanium alloy. So are most traditional rods, but since the Magec System was designed to move inside a patient without surgical intervention, some researchers believe the implant’s metal components can rub together, releasing metal particles into the body.

Scientists have long-suspected that medical implants with metal components can cause a condition known as metallosis, in which the buildup of metal particles causes pain, tissue death and surprising masses of inflamed tissue called pseudotumors.

Metallosis is best-known as a side effect of metal-on-metal hip implants, but a number of reports have also found evidence of the condition in Magec growing rod patients.

Reports Of Metallosis In Magec Patients

In 2016, the British Scoliosis Society polled medical centers in the United Kingdom for data on their experiences using the Magec System in young children. 11 facilities responded, sending in reports on 195 children who had all received Magec growing rods. A total of 43 patients, or 22% of the study’s total population, had undergone “unplanned revision surgeries,” the researchers found. In 23% of these operations, metallosis was diagnosed.

Another warning sign came in April 2016, when English surgeons published a report on two Magec patients in the Spine Journal. In both children, a Magec growing rod’s actuator pin had fractured. The implants were removed and, during revision procedures, doctors noted metallosis in the soft tissues of both patients.

Six months later, a similar report came out in Spine. Led by surgeons at the San Diego Spine Foundation, a team of physicians reviewed the medical records of 23 children who had undergone Magec implantation procedures. While the study only followed these patients for two years, 11 of the patients experienced “implant-related complications.” Two Magec growing rods fractured entirely inside the body. A total of 10 children underwent revision procedures and, in six of these surgeries, metallosis was blamed as a primary contributor.

Does Metallosis Drive Premature Implant Failure?

Metallosis is a problem in and of itself. As the body’s soft tissues begin to collect metal particles, patients can experience severe pain, swelling and inflammation.

While these symptoms are usually isolated to the implant’s location, there is an additional risk that metal particles will enter the bloodstream, circulating throughout the body and causing systemic reactions. But metallosis can have another effect. As doctors note in Clinical Orthopaedics and Related Research, tissue damage related to the accumulation of metal particles around an implant may be a major cause of premature device failure.

Implant Fractures In The Medical Literature

The medical literature has also come to include a number of studies describing premature implant failures in Magec growing rod patients.

In April of 2016, physicians in Wales explained their results after following 8 children who were treated using the Magec System. Though the study only included 4 years of data on these patients, 6 of the children were forced to undergo unplanned revision surgeries in that period. 2 of these operations were blamed on a fractured growing rod, while a 3rd procedure was chalked up to a broken drive pin. A 4th device simply failed to lengthen after being implanted, according to their paper in the Spine Journal.

In December of the same year, the same Welsh team published another report, with almost identical results. This second paper covers 5 other revision surgeries, in which 7 Magec System growing rods were removed from patients. 2 of the implants had broken inside a child’s body. What’s more, the researchers identified evidence of “tissue metallosis” on 6 of the 7 rods. When the implants were cut open, “a significant amount of metal debris was found.”

Fractures May Release Metal Into Patients’ Bodies

A group of mechanical engineers from England found similar results in April 2017, when they cut open over a dozen used Magec growing rods to examine the insides. All of the growing rods contained “titanium wear debris,” according to their paper, published in Spine. 90% also showed evidence of metal wire on the outside.

And, in more than 50% of the implants, the engineers noted “O-ring seal failure.” In short, the O-ring, designed to keep the rod’s internal compartment separate from the patient’s body, had broken. “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,” the researchers conclude.

Help Our Investigation & Share Your Child’s Experience

Our experienced attorneys have been approached by a number of families who are concerned by recent study results on the Magec System for early-onset scoliosis. After fielding their questions, we realized that hundreds of other families may be interested in learning more about the safety of these new growing rods.

As a result, our lawyers have launched a full investigation into Magec growing rods. We want to learn everything there is to know about these devices, and we’re starting with the children and parents who have been directly affected by them. We want to hear your experience. If your child was implanted with Magec growing rods, contact our lawyers today to share your thoughts.

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