Mild scoliosis is widespread. In the United States, around 2% to 3% of the population has at least some abnormal curvature to the spine, according to the American Association of Neurological Surgeons. Most of these people don’t require medical attention. Severe cases of scoliosis, however, can lead to life-threatening heart and lung disorders later in life. The problem is particularly acute for young children.
While the majority of scoliosis patients will be diagnosed during adolescence, a smaller number will be found to have early-onset scoliosis (EOS), which is diagnosed before the age of ten.
The spine in children over the age of ten has largely finished developing, the Children’s Spine Foundation reports. But a young child’s spine will continue to grow, which is why EOS almost always requires medical intervention.
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Allowing a severe spinal curvature to develop unabated puts kids at risk. Children who aren’t treated for early-onset scoliosis can have trouble gaining weight. Their internal organs are unlikely to develop properly and, in the most extreme cases, the condition can lead to an earlier death.
When braces, casts, and other orthotic devices are not enough to control the severe spinal curvature seen in early-onset scoliosis, surgeons usually rely on growing rods, surgical implants that guide the spine’s development as a child gets older.
But as the spine grows, these rods need to be lengthened (or “distracted”) occasionally. And traditional growing rods can’t just be extended inside a patient’s body. Instead, surgeons are required to perform yet another invasive procedure, removing the old implants and replacing them with longer ones. Even worse, children must undergo these revision surgeries, on average, every six months, according to Columbia University Medical Center.
That means more pain, longer recovery times, higher rates of surgical complications and healthcare-related infections, to say nothing of the emotional toll these revision procedures take on patients and their loved ones.
These issues are well-recognized, and particularly hard on patients who have early-onset scoliosis. San Diego-based medical device manufacturer NuVasive came along to solve the problem. The company’s Magec System received clearance for sale throughout Europe and the United Kingdom in 2009. Seven years later, in September 2016, the US Food & Drug Administration cleared Nuvasive’s implant system for use in the United States.
Unlike traditional growing rods, the NuVasive Magec System relies on magnetic technology to reduce the need for invasive surgeries. Instead of operating inside the patient, doctors can use the system’s external remote control to alter the positioning of each growing rod.
All of this occurs from the outside; it’s the magnetic technology developed by NuVasive, and contained in each implanted growing rod, that hopes to eliminate the progression of spinal deformities. In theory, only one invasive procedure is necessary – the first surgery that puts the Magec growing rods in place. As a result, far fewer operations are required.
The only problem? A growing number of medical researchers are beginning to worry about the Magec System’s safety. In a spate of recent articles, surgeons and mechanical engineers from around the world have highlighted a number of potential problems with the device, including reports of metallosis and premature device failures.
In a 2017 report for the journal Spine, mechanical engineers describe what happened when they analyzed 34 Magec System growing rods that had been removed from 18 child patients.
The rods had been taken out, the researchers note, for a variety of reasons, including “failure of rod lengthening.” But upon cutting the implants open to investigate their internal components, the engineers found “titanium wear debris” inside all 34 of the implant rods. And 91% of the rods exhibited wear on the extending bar.
More than 7 in 10 of the devices showed “substantial damage to the radial bearing,” while in over half of the implants, researchers discovered “O-ring seal failure.” In just under half of the rods, the implant’s drive pin had fractured, but the analysts determined that this was a result of the device’s failure, not the problem’s ultimate cause.
In their conclusion, the researchers focused on the titanium debris found in all 34 of the analyzed devices. This wear, which could in theory release metal particles into surrounding body tissues, may explain the recent reports of metallosis in Magec patients, the paper says.
NuVasive’s Magec System growing rods are made from a titanium alloy, just like most traditional growing rods. But new research suggests that, over time, the titanium components of the Magec System can rub against one another and release ionized metal particles.
Medical researchers have long suspected that metal implants, when allowed to abrade inside a patient, can lead to metallosis, a medical condition that occurs after metal debris begins to build up in the body’s soft tissues. While the diagnosis remains controversial, metallosis is generally accompanied by symptoms of pain, inflammation and tissue damage around the implant site, as well as pseudotumors, collections of inflamed cells that look similar to tumors.
Metallosis is a problem for a number of reasons. Alongside the discomfort it causes patients, the condition can also threaten the integrity of implants, as the healthy tissue that would hold a device in place is slowly eaten away. That’s why a group of San Diego physicians proposed in 2012 that the symptoms of metallosis are leading contributors to the premature failure of metal-based medical implants.
A review of the medical literature on Magec Systems also centered around metallosis reports. Writing in a 2017 edition of the Bone & Joint Journal, a group of doctors from the Royal Victoria Infirmary note that “the MAGnetic Expansion Control (MAGEC) system is used increasingly in the management of early-onset scoliosis. Good results have been published, but there have been recent reports identifying implant failures that may be associated with significant metallosis surrounding the implants.”
The British experts go on to cover a series of studies that have described high device failure rates in young Magec System patients. A 2016 paper led by physicians at the San Diego Spine Foundation explained the experiences of 23 patients who were followed for two years after receiving Magec System implants. Eleven of the children, who on average were around 8 years old at the time of follow-up, suffered complications that required a revision procedure. In two of the patients, a Magec growing rod broke. Issues with the device’s anchorage resulted in two more surgeries. The remaining six revisions were attributed to metallosis and “failure of lengthening.”
An earlier report, published in the Spinal Journal, found a similarly-high need for revision procedures. Of the 8 children included in the study, 6 patients required a total of 8 separate revision procedures after a four-year follow-up period. The rods fractured entirely in two patients.
In June 2017, doctors from France published the results from their analysis of 30 Magec System patients in the European Spine Journal. While the researchers noted that magnetically-controlled growing rods “provide[…] satisfactory deformity correction,” they also link the new technology to a “substantial complication rate.” After an average follow-up period of 18.4 months, the group identified 24 device complications, including 3 “rod breakages” and 6 “failure of […] lengthening.” 9 of the patients required a total of 13 revision surgeries.
Even earlier, the British Scoliosis Society conducted an evaluation of the Magec System’s performance, soliciting reports from 17 medical care facilities that use the device in clinical practice. The research group’s final analysis included data from 11 health care providers who had implanted the Magec System in 195 patients (a total of 369 magnetically-controlled growing rods). Complication rates, again, appear high. Unplanned revision procedures were performed on 22% of the patients and, in 10% of these children, metallosis was diagnosed. 6% of the patients had experienced a growing rod fracture. And in a further 7% of the children, the device’s drive pin had broken.
Like all medical device manufacturers, NuVasive has a legal duty to create implants that work as intended and encourage, rather than threaten, patient health. And, when a product poses acceptable risks, the company has a responsibility to warn patients and health care providers about the danger. While researchers have only begun to look into the safety of NuVasive’s Magec System, their early results have caused some concern in the medical community.
If your child was implanted with a NuVasive Magec System and experienced potential complications, contact our experienced New York product liability attorneys today for a free consultation. Some families may be able to secure financial awards to compensate for the costs of revision surgery, additional medical procedures, physical pain and emotional trauma. Call now to learn more about your child’s legal options – at no cost and no obligation.
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