NUVASIVE RODS LAWSUIT
The American Association of Neurological Surgeons (AANS) reports that scoliosis—an abnormal curvature of the spine—affects about six to nine million people in the United States. The primary age of onset is 10-15 years of age, but the disease can also develop in younger children. When it does so, it’s called “early onset scoliosis (EOS),” and typically requires immediate treatment to prevent further complications down the road.
Though some children can delay or even avoid surgery through the use of braces and casts, if these methods aren’t effective, surgery is generally recommended.
The challenge is to stop the spinal curve from progressing without negatively affecting the child’s growth.
A common surgical treatment involves implanting growing rods that are attached to the spine above and below the curve. Every six months, these rods have to be surgically lengthened to accommodate the child’s growth.
The Nuvasive Magec System was designed to spare children and their families from the need for repeated surgeries. An alternate growing rod solution, it uses magnetic technology to allow doctors to lengthen the rods externally, without having to perform repeated surgeries. In this way, the rods can be adjusted as needed while reducing the risks and potential complications associated with multiple surgeries.
Recent reports, however, have linked the Nuvasive Magic System to other unexpected complications that may land a child back in the operating room. The rod’s internal mechanisms may corrode or fracture, for example, causing tissue damage and requiring additional corrective surgeries. If the rod develops surface degradation, this can also interfere with the magnetic function, meaning that doctors will be unable to lengthen the rods using the external remote control.
Parents and their children thus end up having to endure more hospitalizations and medical costs they didn’t expect, say nothing of the related physical pain and emotional trauma the child endures. Chaffin Luhana lawyers are currently investigating cases in which the Nuvasive Magec System didn’t perform as advertised, in the effort to help families recover damages.
What is Early Onset Scoliosis (EOS)?
The Children’s Hospital of Philadelphia (CHOP) estimates that there are more than 100,000 children in the U.S. diagnosed with scoliosis each year. Most are diagnosed between the ages of 10 and 15. The condition causes the spine to curve abnormally.
While a healthy spine has normal curves at the lumbar region and cervical region, scoliosis causes the spine to curve sideways. It may do so only mildly, or it can be severe enough to cause visible deformity. The child may lean to the right or left, or have shoulders or hips that look uneven.
EOS is defined as scoliosis that is diagnosed between birth and the age of eight and is considered rarer than regular scoliosis. Scientists don’t know what causes it, though in some cases it seems to be connected to cerebral palsy and muscular dystrophy. It can be very serious, however.
Sometimes the curve corrects itself with growth, but other times it only gets worse without treatment. When that happens, the condition can become disabling, reducing the amount of space within the chest and potentially causing lung and breathing problems. If the rib cage starts pressing against the lungs and heart, it can also cause heart damage. Other complications include chronic back pain and an uneven appearance, which can affect self-esteem and personal image.
Treatments for EOS include the following:
- Watchful waiting — sometimes the curve corrects itself as the child grows
- Back braces — most are made of plastic and fit under the clothes, and are worn day and night
- Body casting — similar to braces, these are more rigid options to help correct curvature
- Surgery — if bracing and/or casting fails, surgery is the next option
Traditional scoliosis surgery involves implanting one or two growing rods under the skin and attaching them to the vertebrae above and below the curve. These implants are intended to guide the spine to straighten out as the child grows. They require multiple surgeries, however, as the child has to return to the hospital to have the rods manually lengthened about every six months.
Nevertheless, growing rods have “revolutionized the treatment of EOS,” according to one study, helping children to correct spinal curvature as they grow. The rods and recurrent surgeries can create complications, however, particularly in young children. These include infections, skin problems, wounds healing issues, and spinal fusion. Children can also become traumatized by the need for regular surgeries.
What is the Nuvasive Magec System?
The FDA initially approved the Magec System for EOS in September 2014. At the time, it was designed and manufactured by Ellipse Technologies, Inc., a medical device company headquartered in Irvine, California. The device was approved via the 510(k) fast-track process, which doesn’t require a company to conduct clinical trials to show safety and efficacy.
Instead, Ellipse only had to prove that their product was similar to one already on the market. They compared it to the Harrington Rod System, a spinal rod corrective system that was developed back in the 1950s. Ellipse did report on a retrospective clinical trial that was conducted outside the United States, however. These showed that the Magec System provided the “benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular surgical lengthening procedures in these children.”
In early 2016, Nuvasive acquired Ellipse for over $380 million, and in September 2017, the FDA cleared a redesigned Magec System for sale in the U.S., which had a Nuvasive’s Reline Small Stature system for pediatric use. The system utilizes a titanium adjustable growing road that is surgically implanted and secured to the spine with screws, hooks, or other connectors; and has a handheld external remote controller that’s used by the doctor to lengthen the rods from outside the body. The system also includes a “Magec Wand” that locates the magnet within the rod from outside the body. Nuvasive says this allows for “optimized adjustment control” of the rod when needed.
Instead of having to go to the surgery room and go under anesthesia for adjustments, children implanted with the Magec System are supposed to be able to have the rods adjusted at the doctor’s office. When the child has achieved full growth or when the doctor feels that the rods have completed their purpose, they are surgically explanted.
If everything worked as advertised, this system could be a positive alternative to traditional growth rod treatment. Studies, however, have shown that the Magec System is defective and use of the device may result in the child suffering serious complications and requiring revision surgery to remove and replace the Magec System.
What is the Problem with the Nuvasive Magec System?
As touted by Nuvasive, the main benefit of the Magec System is that it supposedly cuts down on the number of surgeries that children and their families have to go through. Unfortunately, because of potential device defects, that’s not always the case.
Reports of problems associated with the Magec System include the following:
- Metallosis resulting in tissue damage and other complications
- The rods or their parts become corroded
- The rods don’t lengthen as they’re supposed to on subsequent doctor’s visits
- The rods bend or break while inside the child
- The rods become loosened from the spine because the hardware attaching them becomes disengaged
- Part of the rod breaks away from the rest
In a recent 2017 study on the Magec System, researchers examined five patients who had to have their rods removed. There were nine rods total explanted, and when they were analyzed, researchers found that three out of the nine had a fractured pin. All showed evidence of surface degradation, and there was “considerable corrosion along the internal mechanism.”
The researchers concluded that a third of the rods had failed because of pin fracture “secondary to corrosion of the internal mechanism,” meaning that the corrosion caused the fracture. They advised surgeons that if the rods could not be lengthened as expected, it could be because of corrosive debris building up inside the mechanism and preventing normal function.
Because the rods are made of titanium, they may shed metal ions into the surrounding tissues and bloodstream. If these ions get into the bloodstream, they can cause “metallosis,” which results from a buildup of metal debris in the tissues of the body. Symptoms of metallosis include:
- Swelling and inflammation
- Development of tissue damage or pseudo-capsules
- Loosening or dislocation of the implant
In another 2017 study, researchers noted that while there had been some good results published with the Magec System, “there have [also] been recent reports identifying implant failures that may be associated with significant metallosis surrounding the implants.” They urged surgeons to proceed with caution regarding patient selection and selection of the appropriate treatment system, and to closely monitor patients until they stopped growing.
In an earlier 2016 study, among other findings, the researchers reported that two of six patients implanted with the Magec System developed “loss of distraction,” which means that after implantation, the rods could no longer be lengthened without surgery. Additionally, one patient sustained a rod fracture.
Finally, in a January 2018 study, researchers analyzed Magec rods to find out about their modes of failure. They noted that “being more complex than conventional growing rods,” they were “perhaps more likely to succumb to multifarious failure modes,” adding that metallosis had been reported in failed Magec rods.
They then analyzed 34 Magec rods explanted from 18 children at seven spinal centers in the United Kingdom. They found that titanium wear debris inside all of them, with 91 percent showing measurable wear of the extending bar toward the magnet end. They also reported “substantial damage” to the radial bearing in about three-quarters of the rods, with O-ring seal failure in over half. In 44 percent of them, the drive pin was fractured.
The researchers concluded that the high volumes of titanium wear debris and the O-ring seal damage “likely accounts for the metallosis reported” with some Magec rods.
Types of Injuries Associated with the Nuvasive Magec System
Patients implanted with the Nuvasive Magec System may experience the following injuries:
- Tissue damage
- Necrosis (tissue death)
- Premature implant failure
- Skin discoloration
- Unplanned painful revision surgeries
Nuvasive Magec System Lawsuits
Parents and their children have no one to turn to for help with EOS except their doctors, and doctors rely on companies like Nuvasive to be thorough and responsible when it comes to creating medical devices like the Magec System. It appears that the system is not performing as advertised, and Nuvasive has a responsibility to correct the issue immediately. They have not yet issued any recalls or corrective actions, however.
If your child has been forced to go through painful revision surgeries or other corrective surgeries because of a broken or defective NuVasive Magec rod, you may be eligible to file a Nuvasive Magec System lawsuit to recover damages.
The defective medical device attorneys at Chaffin Luhana is now investigating these cases and invites you to call today at 888-316-2311.