NuVasive MAGEC® System Lawsuit Information
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Did Your Child Suffer Metallosis, Device Breakage, or Revision Surgery after Being Implanted with NuVasive MAGEC System?
The NuVasive MAGEC System is a relatively new device approved for the treatment of Early Onset Scoliosis (EOS), a serious condition in which there is no known cause (idiopathic). Typically, what differentiates EOS from infantile or juvenile scoliosis is that children with EOS may have other health issues such as deformity of the chest wall, spina bifida, cerebral palsy, or other neuromuscular disease. Idiopathic scoliosis is typically categorized based on age-
- Infantile Idiopathic Scoliosis when diagnosed in children up to age 3
- Juvenile Idiopathic Scoliosis when diagnosed in children between the ages of 3 and 8
- Early-onset Idiopathic Scoliosis encompasses idiopathic scoliosis diagnosed from birth to age 8 and is generally accompanied by a secondary issue.
NuVasive MAGEC System for Early Onset Scoliosis Associated with Device Failures, Metal Toxicity, and Revision Surgery
Generally, a young child with EOS will present with one of more of the following symptoms-
- Uneven shoulders, one shoulder blade protrudes more than the other
- Ribs are more prominent on one side
- Uneven hips
- Child leans to the one side
Depending on the severity of the curvature of the spine, the growth of some children will need to be monitored, while other children with EOS will be treated with a brace, serial body casting, or with surgical interventions including the implantation of grow rods.
Traditional Grow Rods vs Magnetically Controlled Grow Rods
Surgical intervention for the treatment of EOS can include attaching grow rods to the vertebrae and spine below and above the curve to guide and straighten the spine as the child develops. This method may be used if the child is too young to undergo a spinal fusion or if the curvature is too severe for non-invasive measures to be effective. While grow rods have been shown to be safe, their use requires the child patient to undergo invasive surgery about every six months to lengthen the rods as they grow and develop. These procedures are risky because they repeatedly expose young children to the dangers of anesthesia and infections.
However, a relatively new type of surgical treatment for children with EOS uses magnetically controlled grow rods (MCGRs) that can be extended using an external remote-control device without the need for general anesthesia or invasive surgery.
The NuVasive MAGEC System requires a surgery to implant the magnetically controlled grow rods, but the rods can be extended every three to six months using a remote control. The titanium rods have a magnetic component that is activated by the remote control to slowly expand, eliminating the need for repeated surgeries to adjust the grow rods.
The MAGEC system has been touted as safer than traditional grow rods because there are fewer surgeries, less anesthesia, and faster recoveries. However, serious adverse events have been associated with the device, including premature device failures, tissue necrosis, metal toxicity, and risky revision surgeries.
These failures and complications are causing researchers to scramble to determine how safe and effective the device actually is, and what harm the device may cause a child patient when complications arise. Researchers and medical experts are analyzing patient data and evaluating adverse event reports to determine the scope of the issues, and already they have warned physicians to be cautious when choosing the MAGEC System for young patients and to be aware of corrosion and degradation issues.
MAGEC Rods Fail to Lengthen
Despite being touted as a safer and more efficient treatment device, the MAGEC system has been associated with device failures. In fact, researchers analyzed 34 grow rods that had been removed from 18 patients in seven different spine centers in the United Kingdom and found measurable wear in the extension bars.
The study, published in the journal Spine, also noted problems and failures with other device components, including-
- Substantial damage to the radial bearing in 25 rods
- O-ring seal failures in 18 rods
- Fractured drive pins in 15 rods.
Study authors reported that these failures may explain why some patients are developing a serious condition called metallosis, a type of metal toxicity.
MAGEC Pin Failures May Be Caused by Corrosion and Degradation of System
Following adverse event reports, researchers began investigating the cause of pin failures in the MAGEC device. They published their findings in the European Spine Journal which said that one-third of MCGRs studied had pins that fractured due to internal corrosion. Study authors reported they have found degradation on the surface of the rods and considerable amounts of internal corrosion. The study advises doctors to consider that a buildup of corrosive debris could cause problems with distraction (lengthening) and cause pins to break.
As researchers continued to investigate the safety and efficacy of MCGRs like the MAGEC system, they discovered that though early study results showed promise, mid-term results were not as good. In fact, researchers warned that MCGRs should be used with caution after finding that of the eight cases analyzed, patients experienced significant issues including-
- 8 revision surgeries
- 4 rod problems
- 3 proximal screws pulled out
- 1 proximal junction kyphosis
Researchers published a study in Spine Journal that even though MCGRs like MAGEC have a lower rate of superficial and deep infection than traditional rods, they have a significantly increased risk of metal problems and unplanned surgeries.
Metal Toxicity Seen in Some Children Implanted with MAGEC System
As was seen with the metal-on-metal hip replacement devices, when metal components of implant devices rub together, they can release metal ions into the body and cause a serious condition called metallosis. Because there is little known about how metallosis or metal toxicity can affect a growing child, this serious adverse event is very troubling. Metal toxicity can cause of a number of serious health problems in adults, such as-
- Cardiomyopathy – disease that affects the heart muscle and makes it more difficult for the heart to pump blood to all areas of the body.
- Cognitive impairment – developmental disorder in which adaptive skills and intellectual functions are affected.
- Hearing problems
- Necrosis – non-reversible death of tissue surrounding the implant, often indicated by a rash.
- Nerve damage
- Pain around the implant
- Vision problems
- Renal function impairment – kidneys don’t function normally.
- Thyroid dysfunction – production of thyroid hormones is impaired, affecting growth, development, and many body functions.
- Osteolysis – destruction of bone
Because devices like MAGEC have been associated with an increased risk of metallosis, and experts simply do not yet know what complications it could cause in developing children, researchers published a Note of Caution in the Bone & Joint Journal urging surgeons to use caution when choosing MCGRs for the treatment of EOS in young patients. Patients who are at risk for metallosis should have their blood tested to check metal levels. Patients with the symptoms of metallosis should seek medical attention as quickly as possible.
Children Forced to Undergo Risky Revision Surgeries When MCGRs Like MAGEC Fail
One of the marketing points of the NuVasive MAGEC System is that it eliminates the need for children to undergo invasive surgeries every time the rods need to be lengthened. Yet, adverse event reports show that children who receive the MAGEC system may experience serious complications like device failures and metal toxicity which force the child to undergo risky revision surgery, so doctors can try to repair the device or remove it completely. Unfortunately, there is no real treatment for metallosis, and as stated, researchers do not know how titanium ions shed into the bloodstream could affect a growing child now and in the future. Because metallosis can also cause tissue necrosis around the implant device, doctors must assess the damage before determining a new treatment method. To make matters worse, the additional surgeries that a child must go through exposes them to increased risks of infections and the dangers of general anesthesia.
Join Our Fight for Justice and See if Your Child Is Entitled to Compensation
We are currently investigating NuVasive MAGEC System device failures in patients who have EOS and we want to hear from parents whose children have been implanted with the device. We have been leading the fight against dangerous device makers for decades and we stand ready to fight for the rights of your child.
Device makers should never take risks with the lives of the public, but it’s even worse when they design and market a device specifically for children when they know or should know that it could cause the child to suffer even more harm than the condition it was designed to treat.
If your child has received the NuVasive MAGEC System for early onset scoliosis, we want to hear from you. Talk to us today to learn if you are eligible to join our fight for justice, and to see if you are entitled to compensation. We don’t let medical device manufacturers get away with putting their bottom line before the lives of children, and we won’t let them get away with risking the health and wellbeing of your child. Contact us today to learn more about how we can help you seek justice and to learn if you and your child are entitled to significant financial compensation.