NuVasive is a relatively new medical device to treat scoliosis. The NuVasive device uses adjustable growing rods versus the traditional method which required the fixed rods be replaced as the patient's scoliosis is treated and their body adjusts. NuVasive Magec (Magnetic Expansion Control) allows the rods to be adjusted using a remote-controlled device versus a surgical procedure. This product has been marketed as a breakthrough in treating scoliosis. But at what costs?
Children Are the Most Common Sufferers of Scoliosis
Patients with scoliosis endure a lot. Scoliosis is a neuromuscular disorder that causes your spine to develop an unnatural curve. Scoliosis is a progressive condition and, left untreated, can cause permanent physical deformities leading to pain and permanent physical limitations. Typically, patients with scoliosis have the thoracic and lumbar regions of their spine affected the most.
Who gets scoliosis? The condition appears most often during the ages of 10-14 years old. Children can suffer spinal curvatures anywhere from 15 to 50 degrees or more. Some children have curvatures that are so severe it can cause the pelvis to tilt abnormally. The precise cause of scoliosis is unknown yet researchers believe it is caused by a miscommunication in the patient’s motor sensory output. Anyone with a curvature of greater than 10% is often diagnosed with scoliosis. Recent statistics indicate that 1% of people with scoliosis require surgical correction to treat their curvature.
There are two main types of scoliosis: structural and nonstructural. Patients with structural scoliosis typically have spine curvatures that cannot be reversed. Most patients with structural scoliosis have underlying conditions such as genetic conditions (Down Syndrome or Marfan Syndrome), invasive tumors, birth defects (congenital defects), cerebral palsy, and muscular dystrophy. These patients often exhibit symptoms of spinal curvature very early in their childhood. In some instances, patients are born with the condition. Nonstructural scoliosis patients have backbones that are fully functional and then begin to exhibit a curvature that develops slowly over time.
To diagnose scoliosis, the patient’s hips, shoulders, ribs, and spine must be examined. Often, a pediatric orthopedist or spine specialist will use a device called a Scoliometer to measure the curvature. Other times, physicians will use imaging studies such as CT scans, MRI’s or plain film x-rays to make the diagnosis. Once diagnosed, most patients with non-structural neurological scoliosis are treated with a rigid spinal brace to wear almost non-stop until the curvature is corrected.
A specific type of scoliosis called early-onset scoliosis (EOS) affects children less than 10 years old. Left untreated, children with EOS can develop very debilitating and often life-threatening conditions such as lung deformities and serious breathing conditions due to the crowded space in the chest cavity caused by the curvature of the backbone. This is a very serious condition called Thoracic Insufficiency Syndrome (TIS). In addition, children with untreated EOS can suffer permanent impairment of their ability to move and function.
Surgical Treatment Was Often the Only Treatment for Scoliosis
Prior to NuVasive’s Magec system, children with scoliosis curvatures that were too significant to control with bracing and casting were normally treated with growing rods. This most often includes children with curvatures greater than 50-60 degrees. The rods were surgically attached to the child’s spine above and below the curvature and then periodically lengthened during follow-up surgical procedures. This would continue until such time that the child is developed enough to undergo a spinal fusion to permanently correct the curve and affix it in its proper position. The corrective surgeries would typically take place every 6-12 months until around age 13.
The NuVasive Magec System Reduces the Number of Surgeries Required
Enter the NuVasive Magec system. The system is surgically implanted (often using the Reline posterior fixation system) to treat patients with severe spinal curvature deformity conditions. Specifically, the system is designed to treat children with moderate to severe EOS. The Magec system is the only magnetically controlled growing-rod-system cleared by the FDA for pediatric spinal deformity. The FDA cleared the Magec system in September 2014 (and later expanded clearance in 2016) and it has since been implanted in hundreds if not thousands of patients. Many children’s hospitals in Kentucky and around the United States are reviewing and using the Magec system. The system is designed to reduce the number of planned surgeries required to treat patients with early onset scoliosis (EOS). The Magec system uses a single-use spinal rod that is implanted by a surgeon to brace the spine during growth and includes a small internal magnet controlled by an external remote control device. The rod can be lengthened after it is implanted using the external control. This is performed in a physicians office. The ability to lengthen the rods without the need for surgery is a major advantage because it eliminates the need for “distraction” surgeries traditionally required for children being treated for EOS. With over $811 million in revenues reported in 2015, NuVasive is a growing medical device company that is moving into the pediatric specialty care area. Their Magec system has been heavily marketed to the pediatric orthopedic community.
Prior to the approval of the NuVasive Magec System, many children with EOS were treated with growing rods that were surgically implanted around the age of 6. After being implanted, the rods can be lengthened by a surgeon during what is referred to as a distraction surgery. Although NuVasive has marketed its Magec system as a way to eliminate these surgeries, studies have found that this claim is not entirely accurate. Many children with the Magec system still must undergo additional surgeries. In addition, these children often are placed at higher risk for many problems that are not associated with the traditional method of using growing rods to treat EOS. Many prestigious medical journals and researchers have been reviewing and commenting on the Magec system.
Studies Show the NuVasive System Is Prone to Corrosion and Failure
The European Spine Journal published a study that reviewed and analyzed growing rods placed in patients using the Magec system. They found that almost 30% of the rods had a fractured pin as a result of corrosion of the internal mechanism of the Magec device. This alarming finding was also discussed in the medical journal The Spine Journal which found that the magnetic growing rods do not completely avoid the need for repeated surgeries as claimed by NuVasive. The study found that 46.7% of the patients that underwent magnetically controlled growing rods (MCGR) implantation at the mean age of 7.2 years old underwent an unplanned re-operation within the follow-up period (with a mean time to re-operate of 23 months after the initial surgery). They cited causes of the unplanned re-operation as a failure of rod distractions, proximal foundation failure, rod breakage, and infection. Patients with more frequent distractions had a higher rate of re-operation compared with distraction frequencies between 3-6 months (71% vs. 25%). Moreover, the magnetic growing rods increased the risks of issues with the metal construction of the rods requiring surgeries to replace defective parts. The researchers concluded that long-term comparative studies are required to continue to evaluate the effectiveness of the Magec implant.
The medical journal Bone & Joint Journal published an article urging surgeons to apply caution to patients and construct selection if the doctors are considering the Magec system for treatment of children with early onset scoliosis (EOS). To date, the FDA has received numerous reports and complaints regarding the NuVasive Magec System.
Reported Problems With the NuVasive Magec System:
- Broken rods
- Separation of rods
- Hardware becoming loose or disengaged
- Bent or altered rods
- Rods not responding to distraction from the remote control device
- Tissue dislocation
- Metallosis (metal in the patient’s blood)
Our Attorneys Expect Complaints of Device Failures to Continue
These are just a sampling of the complaints associated with the NuVasive Magec device. As a relatively new medical device, there is a high likelihood that more complaints will arise as the devices are used in more children and the devices begin to age. One of the more troubling adverse reports is that of implant failures that may be associated with metallosis surrounding the implant in patients. As with the metal on metal hip replacement lawsuits that have been occurring for years, metallosis is an often insidious condition that once detected, has already caused significant harm in a patient. For this reason, anyone with a child that has been implanted with the Magec system should question their orthopedic surgeon regarding the need for close monitoring of this condition.
In Kentucky and across the United States, medical device manufacturers have a duty to ensure that their products are both safe and perform as advertised. When companies fail to honor these two promises to their patients they may be held liable for a patient’s injuries. Gray & White Law has a long history of success representing people against medical device manufacturers for defectives products and deceptive marketing. Our firm has received the highest rating possible from multiple peer review publications. We are consistently named as Top Lawyers in Kentucky and listed in the Best Lawyers in the United States for our work in complex injury cases. We employ a dedicated team of highly skilled attorneys and nurses to help you with your case. We offer a FREE CASE EVALUATION to determine if you may be eligible to bring a lawsuit for your injuries.
If you suspect that a loved one has been injured by the NuVasive Magec System, we can help.