Scoliosis is a condition involving curvature of the spine. The spinal column should appear straight when viewed from the front or the back. In a person with scoliosis, the spine curves sideways, either to the left or to the right.
This condition is diagnosed using X-rays in which the curvature of the spinal column is measured in degrees. If the abnormal curvature is greater than 10%, the patient is diagnosed with scoliosis. Approximately one in every 1,000 people has scoliosis severe enough to require medical intervention.
Early onset scoliosis (EOS) affects children under 10 years of age. As their skeletal structures are still developing, children with EOS are at risk of the deformity worsening. If the curvature becomes severe, it can cause crowding in the thorax (chest cavity) to the extent that it cannot support breathing or growth of the lungs. This condition is known as Thoracic Insufficiency Syndrome (TIS). The NuVasive Magec System is designed for surgical treatment of patients with moderate to severe EOS.
Surgical Treatment of Early Onset Scoliosis
Early treatment of children with EOS is important to help control the progression of the spinal deformity and to aid the growth of the chest cavity. Surgical treatment is aimed at preserving the mobility of the spine and avoiding the correction and fusion procedures performed on adolescent scoliosis patients.
Many surgical treatments for EOS utilize “growing rods,” typically implanted surgically between the ages of 5 and 7. These rods can be surgically distracted (lengthened) as the child grows. After the initial implanting of the rods, the child must undergo additional surgeries for the purpose of distracting the rods.
The NuVasive Magec System is an alternative surgical EOS treatment with “noninvasive growth modulation,” using a magnetic controlled growing rod system, which claims to eliminate the need for additional surgery to distract the rods. However, studies have found that this system does not actually eliminate the need for repeated surgeries as suggested by the company, and it also comes with a significantly higher risk of problems with the surgically implanted device.
Problems with Magnetic Controlled Growing Rod Systems
In a study published in the European Spine Journal, researchers analyzed 9 of the magnetically controlled growing rods that had been retrieved from patients. They found that one-third of these rods had a fractured pin, secondary to corrosion of the internal mechanism.
Researchers who conducted a study published in The Spine Journal (the official journal of the North American Spine Society) found that, although magnetic controlled growing rods have a lower rate of deep and superficial infections than conventional growing rods, they do not completely avoid the need for repeated invasive surgeries as suggested by the manufacturer. The study also found that magnetic growing rods significantly increase the risk of metalwork problems, resulting in unplanned surgeries to replace defective devices.
The U.S. Food and Drug Administration (FDA) has received a number of reports regarding problems with the NuVasive Magec System after surgical implantation in the patient, including:
- Rods not distracting
- Separated rods
- Hardware disengaged
- Bent rods
- Broken rods
- Tissue pigmentation and discoloration
Legal Help with NuVasive Magec System Injuries
NuVasive Specialized Orthopedics, Inc., manufacturer of the NuVasive Magec System, has a responsibility to ensure that the medical devices it produces perform as they should and are safe and do not endanger the health of the patient. If the company has failed to do so, individuals who have suffered injury as a result have a right to seek compensation for their losses.
At Meyers & Flowers, we represent people who have been injured by defective medical devices. If your child has been forced to undergo additional surgery to replace defective metalwork or suffered injuries that you suspect were caused by the NuVasive Magec System, our knowledgeable trial lawyers can help. The first step is to schedule a no obligation consultation for a free case evaluation by one of our attorneys.
Our dedicated legal team has a successful track record recovering substantial settlements and verdicts for our clients. We have been awarded membership in the elite Million Dollar Advocates Forum and our firm has been named among the Best Law Firms of 2017 by U.S. News & World Report. You can have confidence that we have the knowledge, skills, and experience to aggressively pursue the meaningful compensation your family deserves if your child has been harmed by surgical treatment for scoliosis with the NuVasive Magec System.
- European Spine Journal: Analyzing a mechanism of failure in retrieved magnetically controlled spinal rods.
- The Spine Journal: Do magnetic growing rods have lower complication rates compared with conventional growing rods?