NuVasive MAGEC System Lawyer
The MAGEC System is a magnetic controlled growing rod system that is used to treat Early Onset Scoliosis (EOS) in children. It is manufactured by NuVasive, Inc.
The MAGEC System includes a titanium adjustable growing rod that is surgically implanted and can thereafter be distracted, or lengthened, externally as the child grows. The magnets within the growing rod are controlled by magnets in an External Remote Controller, which allows the physician to control how the rod is lengthened.
NuVasive advertises the MAGEC System as an innovative solution to the challenges of treating EOS. Traditionally, treatment for EOS included growing rods that required additional surgeries to be distracted. These surgeries could be as often as every 6 months.
NuVasive touts the MAGEC System as an alternative to constant surgery. For patients and families, this means minimized risk of infection from open surgical sites, less anxiety and hospital time, reduced medical bills, and less anesthesia exposure to a child’s still developing brain.
However, there have recently been several reports of the MAGEC System failing in various ways, causing children to undergo the additional surgery NuVasive promised would be avoided. To learn more and see if you qualify for a lawsuit against the manufacturers of this device, contact our NuVasive MAGEC System lawyers to discuss your case.
What is Early Onset Scoliosis?
Early Onset Scoliosis is scoliosis that is diagnosed before the age of 10. Scoliosis is an abnormal sideways curvature of the spine.
The distinction between scoliosis and EOS is made because before the age of 10, the spine is still growing, and therefore the treatment must be very different for these young patients.
There are four main causes for EOS:
- Idiopathic – Curvature for which there is no apparent cause
- Congenital – Vertebrae develop incorrectly inutero. Sometimes associated with cardiac and renal abnormalities.
- Neuromuscular – Occurs in the presence of neuromuscular disorders such as spinal muscular atrophy, cerebral palsy, spina bifida, and brain or spinal cord injury.
- Syndromic – Associated with syndromes such as Marfans, Ehlers-Danlos, and other connective tissue disorders. Neurofibromatosis, Prader-Willi, and many bone dysplasias may be associated as well.
If EOS is not treated promptly and progresses to a severe state, the spine curvature can begin to crowd the space within the chest cavity. This can lead to Thoracic Insufficiency Syndrome (TIS), which occurs when the chest cavity cannot support normal breathing or lung growth.
Mild scoliosis can occur and remain undetected because it can develop gradually and may not cause any pain. These are the signs and symptoms that manifest when scoliosis has developed:
- Uneven shoulders
- One shoulder blade appears more prominent than the other
- Uneven waist
- Uneven hips
If scoliosis progresses without treatment, the spine will also rotate or twist in addition to curving sideways. This causes the ribs on one side of the body to stick out further than on the other side.
How Does the NuVasive MAGEC System Treat Scoliosis?
The MAGEC System includes a titanium adjustable growing rod that is surgically implanted and secured using spinal fixation components, including pedicle screws, hooks, and other connectors.
The rod braces the spine during growth to minimize the progression of scoliosis. There is a magnet within the rod that allows it to be adjusted by an External Remote Controller (ERC).
When it is time for the rod to be distracted, the ERC is held over the child’s spine and the magnets cause a magnet in the rod to rotate. The doctor can then control the length of the rod externally.
These noninvasive distractions are meant to be quick and painless, and per the doctor’s instructions, the child can often return to normal activity immediately.
Was the NuVasive MAGEC System Approved by the FDA?
NuVasive, Inc. recently announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MAGEC System.
510(k) clearance means that the device simply needs to have a similar intended use and be at least as safe and effective as a device already on the market. In other words, the technological characteristics must be the same as the predicate device, or if different, must not raise new questions of safety and effectiveness.
The FDA determined that the NuVasive MAGEC System was substantially equivalent to the Harrington rod system, which was developed in the 1950s.
This approval system relies on post-market surveillance to detect issues and defects, rather than preemptive testing.
What are the Defects of the NuVasive MAGEC System?
Recently, there have been many reports of failing MAGEC Systems causing dangerous complications in young patients. Studies are now being conducted to determine the long-term effects on these patients as they mature.
The studies are looking at cases where the patient had to undergo unplanned revision surgery, as well as situations where the MAGEC rods were explanted due to serious complications.
These complications include:
- Failure of the rod to lengthen
- Rod fracture
- Drive pin fracture
- O-ring seal failure
- Anchor failure
Any experienced complications from the NuVasive MAGEC System should be documented and discussed with your lawyer.
A study conducted by the British Scoliosis Society found that 43 out of 195 patients (22%) required unplanned revision surgery. Another study done by International Journal for the Study of the Spine found that out of all available data, rod failure as a cause for revision surgery has been reported in as many as 38% of cases.
Many children who experience complications with their NuVasive MAGEC Systems have to undergo either revision surgery to repair the problem, or extraction surgery to remove the device altogether.
These unplanned surgeries discredit NuVasive’s claims that the device is cost-effective and non-intrusive. Children are exposed to increased risk of infection, as well as the unknown risk of increased exposure to anesthesia at a young age. Because the surgeries are unplanned, the financial and emotional stress is heightened for the patient and family.
Is Metallosis Linked to Scoliosis Growing Rods?
There have been recent reports of metallosis caused by scoliosis growing rods in young children. Most growing rods must be lengthened every six months as the child grows. In some cases, metal-on-metal contact occurs as the extending bar is adjusted.
A study conducted on the NuVasive MAGEC System growing rod found that metal-on-metal contact was so prevalent, the diameter of the extending bar had been reduced by the friction. This produced significant titanium debris inside the rod that could easily escape into the child’s body.
Metallosis is one of the more troubling complications of NuVasive MAGEC Systems due to its high prevalence and the unknown nature of long-term side effects.
When there is metal-on-metal contact within a device, the friction can shed metal particles into the body. This causes metal poisoning, or metallosis, which can lead to bone and tissue death, severe pain, and failure of the medical device.
Metal-on-metal contact can occur with MAGEC System rods as distraction occurs. The study conducted by International Journal for the Study of the Spine found that the diameters of the extending bars were reduced in most cases. In some cases, the reduction was so substantial that it could be seen by the naked eye.
In the same study, out of the 34 cases of MAGEC rod explants, all 34 had significant titanium debris inside. Coupled with the frequent failure of the O-ring seal, that debris was likely to escape from inside the rod and enter the surrounding tissues, thus causing metallosis.
Typically, the common symptoms associated with metallosis include:
- Visual impairment
- Auditory impairment
- Cognitive impairment
- Nerve problems
- Heart failure
- Thyroid problems
- Skin rashes
- Loosening or failure of the medical device
However, the long-term effects of high levels of metal ions in children is still unknown. Most studies on metallosis focus on cobalt-chromium ions in adults, but there is little information on the effects of titanium in young children.
There is some evidence suggesting that titanium wear from joint replacements can induce aneuploidy in vitro and in vivo. Recently, links to heart failure have also been reported.
To understand how metallosis from NuVasive MAGEC System may impact your case, contact our attorneys today.
Contact a NuVasive MAGEC System Attorney for Help
As more patients are treated for EOS with the MAGEC System and more reports of complications are filed, NuVasive will be facing legal trouble.
As the manufacturer of the device, NuVasive has a responsibility to its clients and patients. It is the company’s duty to ensure that its products are safe and they perform as designed.
If a patient is injured due to an undocumented complication or device failure, they have a right to seek compensation for their pain and financial losses.
If your child received a MAGEC System implant and later had to undergo revision surgery, you may be entitled to compensation with the help of a NuVasive MAGEC System lawyer
Revision surgery could be necessary if the rod fractures, bends, or fails to distract. In some cases, the device may have to be extracted completely.
If your child develops metallosis from the device, they may have long-term side effects that will require treatment.
In these cases, you and your child could recover compensation for the cost of revision surgery, additional medical treatment, pain and suffering, and more.