Minneapolis NuVasive Rods Lawsuit Attorneys
In July 2021, the FDA issued safety communication to NuVasive concerning reported biocompatibility issues with NuVasive’s MAGEC scoliosis spinal rod system. Several studies indicate that the MAGEC system frequently experiences mechanical component failures resulting in severe biocompatibility complications, such as metallosis.
Scoliosis is an abnormal spinal condition that affects six to nine million people in the United States. While the primary age of onset is between 10-15 years old, early onset scoliosis (EOS) can develop in children before the age of 10. The condition is characterized by a side-to-side curve in the child’s spine that, if left untreated, can lead the child to develop severe deformities and respiratory problems.
To prevent such debilitating complications, immediate treatment is required. More often than not, the treatment of EOS in children involves the implantation of growing rods that attach to the spine’s vertebrae above and below the curve. To accommodate the child’s growth, these rods are surgically lengthened approximately every six to twelve months.
The NuVasive MAGEC system is advertised to reduce the need for repeated intrusive surgeries in children affected by EOS by using magnetic technology that allows a doctor to lengthen the rods externally. However, reports have demonstrated that the system’s endcap can separate from the system, exposing the body to noncompatible materials. This device failure can result in significant complications such as corrective surgery and metallosis. In fact, some reports show that up to 57% of patients have experienced complications from this device.
If your child has developed complications from a scoliosis spinal growing systen, contact one of our defective medical device lawyers at GoldenbergLaw for a free consultation. GoldenbergLaw has 35 years of experience handling national contamination cases.
Case Quick Facts
What is Early Onset Scoliosis (EOS)?
EOS is a condition that develops in children under the age of 10. It is a spinal condition that causes an abnormal, side-to-side curve of the spine. It may even cause the spine to twist into an “S” or “C” shape.
The spinal twists are measured on a spectrum depending on the degree of the curve:
- Mild: less than 20 degrees
- Moderate: between 25 degrees and 40 degrees
- Severe: more than 50 degrees
Most cases of EOS are deemed “idiopathic,” meaning doctors are not able to determine the condition’s cause. However, although the cause may be unknown, EOS often develops rapidly and aggressively. If left untreated, the condition can leave the child with severe chest deformities and respiratory problems.
How is EOS Treated?
The goal of EOS treatment is slow the spinal curve’s progression before eventually correcting it. Treatment includes:
While there are non-surgical treatment options such as observation, bracing, and casting, it is likely that a child diagnosed with EOS will require surgery.
Traditional EOS surgery involves implanting growing rods under the skin that are anchored to the vertebrae above and below the spinal curve. The growing rods help straighten the spine as the child grows. However, the rods need to be surgically lengthened every six to twelve months.
How does the NuVasive MAGEC system work?
The NuVasive MAGEC system was approved by the FDA in September 2014. It was designed to help children suffering from EOS avoid multiple surgeries to lengthen the growing rods.
The MAGEC system consists of a titanium adjustable growing rod that is lengthened by an external remote controller utilizing magnetic technology. The magnetic technology allows a doctor to lengthen the rod externally, instead of requiring multiple invasive surgeries, in a manner that would not inhibit long-term growth.
NuVasive alleges that its MAGEC system benefits young patients by:
- Reducing the number of surgeries required to treat EOS
- Minimizes the risk of infection
- Reduces anxiety for the child-patient
However, recent studies indicate that the MAGEC system often fails to operate as advertised, reducing the alleged benefits and causing severe complications.
What are the problems with the MAGEC System?
NuVasive’s MAGEC system was first recalled in February 2020 due to reports of mechanical failures. After receiving FDA clearance for a modified version of the MAGEC system in July 2020, NuVasive received safety communication from the FDA in July 2021 after additional reports of mechanical failures and biocompatibility issues associated with the MAGEC system.
A Newcastle University study shows that magnetically controlled growing rods are more complex than traditional growing rods and, subsequently, more likely to succumb to product failure. The product failures associated with the MAGEC system are:
- Endcap separation
- Metal particle release
- Rod breakage
- Fixation failure
- Fractured driver pin
- Screw breakage
These failures have been associated with several complications. These complications include:
- Biocompatibility Concerns: when the body’s tissue becomes exposed to the internal components of the rods
- Metallosis: when metallic ions and particles from the titanium rods enter the bloodstream, causing serious pain and necrosis of surrounding tissue
- Revision Surgeries: when the rods fail to lengthen as they’re supposed to, or when they become disengaged or broken
GoldenbergLaw Can Help
If your child has experienced complications from a scoliosis surgery, please contact GoldenbergLaw. We will deliver the “Gold Standard” advocacy you deserve.