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The Nuvasive Magec System is an effective magnetic technology that treats scoliosis using adjustable growing rods. In the past, these growing rods needed to be replaced during follow-up surgeries. However, the latest minimally invasive technology allows the rods to be adjusted using an external remote controller to avoid repeated surgical procedures. The newly redesigned Nuvasive Magec System can treat idiopathic and early-onset scoliosis.
In early September 2016, the Food and Drug Administration cleared the Nuvasive spinal implant system to treat patients suffering from early-onset scoliosis involving comprehensive spinal deformities. Their “RELINE” device is the only available small stature system manufactured with ‘easy to use’ components and small adjustable rods to maximize successful surgical outcomes in the U.S. The FDA 501(K) clearance indicates that the adjustable rods are safe to use with Magnetic Resonance Imaging (1.5 T) devices.
Doctor Suken Shah of the Alfred L. Dupont Hospital for Children stated in prepared remarks that “having clear, defined guidance for conditional MRI compatibility with [the NuVasive Magec System] helps alleviate uncertainty that may have limited surgeons from using the innovative Magec system. This clearance opens up the door for more patients and their families to benefit from this life changing technology.”
In August 2016, the Centers for Medicare and Medicaid Services (CMS) granted Nuvasive’s advanced technology a clearance to use the remotely controlled growth rods, including those in their Magec System.
What is Scoliosis?
Scoliosis is a neuromuscular disorder that causes a sideways curve to the backbone (spine). When the nearly always progressive condition affects most of the spine, curvature can deform the backbone into a C-shape or S-shape, which are considered symptoms of the disorder. Most cases of scoliosis affect the thoracic (chest) area and the lumbar (lower section of the back) area.
Children between 10 and 14 years of age are at the greatest risk for developing scoliosis that can curve the spine from 15 degrees to 50 degrees or more. In some cases, the condition tilts the pelvis.
Scoliosis usually develops from a miscommunication involving the motor-sensory output and input from the lower and upper trunk. It is thought that the brain does not send or receive the correct messages concerning the position or part of the body that needs to move.
There are four specific kinds of scoliosis that include:
- Idiopathic Scoliosis – The idiopathic (unknown origin) form of scoliosis can be defined as adult (18 years and older), adolescent (10 to 18 years old), juvenile (3 to 9 years old) and infantile (birth to three years of age).
- Myelopathic or Neuromuscular Scoliosis – Children with neuromuscular disorders including cerebral palsy and muscular dystrophy can develop myelopathic or neuromuscular scoliosis.
- Congenital Scoliosis – Approximately one of every 10,000 newborns suffer congenital scoliosis that developed in the womb.
- Degenerative Scoliosis – As a degenerative condition, this form of scoliosis usually affects individuals 65 years or older.
The Cause of Scoliosis
Even with advancements in medical technology, doctors, scientists, and researchers have yet to determine a clear cause of scoliosis. However, diagnosticians categorize each specific type as structural or nonstructural. Structural scoliosis, where the curvature the backbone becomes extremely rigid, develops a condition that cannot be reversed. The common causes of structural scoliosis are thought to include:
- Muscular dystrophy
- Cerebral palsy
- Congenital defect at birth
- Down syndrome, Marfan syndrome, or other genetic condition
If the condition is caused by a congenital disorder, the baby will begin to develop scoliosis long before birth. In congenital cases, the vertebrae often fail to divide or grow completely before the child is born. Usually, this condition is not diagnosed until the child was born or later on into the child’s teenage years.
Alternatively, nonstructural scoliosis usually involves a normal working backbone that tends to curve over time. The curvature can be caused by numerous reasons including an appendicitis inflammation, muscle spasm or other online condition.
Before any external or invasive intervention can be performed on the patient to correct scoliosis, the doctor must diagnose the condition by carrying out an extensive physical exam on the patient’s shoulders, hips, ribs, and spine. Many diagnosticians use a Scoliometer (inclinometer) tool that measures the curvature of the patient’s back and the extent of condition’s progression. In many cases, an orthopedic spine specialist or pediatric orthopedist who specializes in scoliosis can make an accurate diagnosis through:
- X-ray Images – The orthopedic surgeon or pediatrician will order x-rays to identify, evaluate, and assess a scoliosis condition. The x-ray can also provide concise information on the angle, location, direction, and shape of the curving backbone.
- Imaging Scan – The doctor may order an MRI (magnetic resonance imaging) scan or CT (computerized tomography) scan to isolate areas of the spine that might be causing the patient’s back pain or discomfort.
Once a doctor has diagnosed the patient as having a neurological scoliosis condition, treatment is usually highly recommended except for individuals with a curved measurement of 24 degrees or less. If the patient’s scoliosis condition measures 25 degrees to 39 degrees, the doctor will likely fit them for a rigid spinal brace to wear nearly around-the-clock. Measurements greater than 40 degrees usually requires surgical intervention.
Spinal fusion or scoliosis surgery options are usually not recommended for children and young adults with backbone curvature measurements of 45 degrees or less because invasive procedures can be risky and result in serious complications. Some of these risks include peripheral nerve deficit, paraplegia, and quadriplegia. In addition, the implants used to correct the curvature can fail by breaking, compressing nerve roots, or piercing the spinal canal.
Adjustable Rods Used to Correct the Spinal Alignment
The major component in a NuVasive Magec System involves a single-use, sterile spinal rod implanted by a surgeon to brace the backbone during growth and bone maturity. The Magec System controls the adjustment of the rod using a small internal magnet and external remote controller. The doctor will periodically lengthen (distract) the adjustable rod noninvasively. This procedure can be conducted in a doctor’s office or outpatient clinic and eliminates the need for follow-up invasive distraction surgeries. If needed, the device can be retracted (adjusted to a shorter position) during a routine office visit.
When successful, this type of planned distraction surgery can reduce the number of follow-up procedures in the years ahead that normally are required to invasively change or extend the length of an implanted rod. This advanced technology can minimize the potential risk associated with multiple surgeries including infections.
According to the Magec Technique Guide, the patient should expect to “have the implanted rod in place for a few months up to two years, depending on spinal deformation severity.” Concluding that the implant is no longer needed requires a physician’s assessment to determine “that the implant has achieved its intended use and is no longer required.” At that point, “the implant may be removed using standard surgical techniques.”
Adjustable Rod System Problems
Studies have shown that there are significant problems with an adjustable rod system that is magnetically controlled. Some published studies show that one out of three implanted rods will develop a fractured pin or have extensive corrosion on the mechanism’s internal parts. A published study in the North American Spine Society Spine Journal revealed that the implantation of the magnetically controlled growing rod is no guarantee the patient will not require repeated invasive surgeries like the manufacturer states. This is because there have been significant problems with the component’s metalwork and other issues that include:
- The rod does not properly distract (extend/expand)
- The hardware fails to engage
- The rods separate unexpectedly
- The rod breaks or bends
- Surrounding tissue becomes discolored or pigmented
Hiring a Lawyer to Assist You in Obtaining Financial Recovery for a NuVasive Magec System
The makers of the NuVasive Magec System, NuVasive Specialize Orthopedics, Inc. are legally bound to protect the consumer against defective medical devices that the company manufactures. However, if any part of the component fails, due to a defective design or faulty manufacturing process, the manufacturer can be held legally responsible for the patient’s damages. In many cases, injured victims will seek financial recompense to cover their losses that could include hospital costs, medical expenses, missed wages from time away from work, pain, suffering, emotional distress and mental anguish.
The reputable Essure attorneys at the Drug Law Center represent clients who have suffered serious injuries caused by bad drugs and defective medical units. If you, or your loved one, have undergone follow-up surgeries because of a defective adjustable rod or the replacement of defective components, we can help. Contact us today to discuss the merits of your case. Let us evaluate your claim for compensation and provide numerous legal options on how to proceed to ensure you have a successful financial resolution.
Working on your behalf, our dedicated, skillful legal team can use our years of experience to aggressively pursue your case for compensation. In addition to holding the manufacturer of the defective device financially responsible, our investigators and legal team can determine if there are other parties at fault for your injuries, including your doctor, surgeon and/or hospital.