Spinal fusion surgery permanently joins together two or more bones in the spine (called “vertebrae”). Unfortunately, many people have been injured by counterfeit or defective spinal implants.
What is Spinal Fusion?
Every day, the spine needs to support tremendous loads, stresses, and strains. When the spine is unstable, spinal fusion surgery may be necessary to provide support for normal movement. External fixation (braces) may be used to help maintain posture and prevent further injury. Internal fixation (spinal surgery) helps permanently maintain alignment of the spine.
During surgery, the disc(s) between diseased vertebrae are removed and a bone graft is inserted between the bones. Traditionally, bone grafts were harvested from the patient’s hip or cadavers. In recent years, surgeons have started using bio-engineered bone grafts. Surgeons may also use metal devices to stabilize the spine until the bones grow together. Metal plates and rods may be attached to the vertebrae using bone screws, wire, and hooks. These implants may be permanent or temporary.
Spinal fusion surgery is used to treat many medical conditions, including chronic back pain, fractures, trauma, scoliosis, degenerative disc disease, spinal stenosis, herniated discs, infection, tumors, and more.
Types of spinal fusion surgery include:
- Neck fusion: This surgery fuses the cervical vertebrae in the neck when they are damaged as a result of injury or degenerative diseases.
- Back fusion: Also known as “lumbar spinal fusion surgery,” this is a common treatment for back pain, degenerative diseases, and excessive curvature of the spine.
Spinal Fusion Injuries, Complications, and Risks
- Defective implants
- Chronic pain in the bone graft area
- Incomplete fusion
- Breakage of the implants
- Surgery may fail to correct health problems
- Severe swelling
- Infection
- Blood clots
- Nerve or spinal cord damage
- Sexual dysfunction, retrograde ejaculation
- Complications of anesthesia
- And more
Medtronic Infuse Spinal Fusion Lawsuits
The Medtronic INFUSE Bone Graft is a new type of bone graft that uses a metal cage filled with bioengineered human growth protein. When the cage is placed between two vertebrae during spinal fusion surgery, the bone growth protein helps fuse the vertebrae into one bone.
In July 2008, the U.S. Food and Drug Administration (FDA) published a Public Health Notification because using the Infuse “off-label” in then neck was associated with life-threatening swelling. In some cases, patients required emergency surgery or tracheotomies to prevent suffocation and death.
Lawsuits include three whistle-blower complaints accusing the company of paying doctors millions of dollars to promote Infuse. The U.S. Department of Justice (DOJ) also launched a federal criminal investigation.
Medtronic Infuse Bone Graft complications can include:
- Severe swelling of the neck (angioedema)
- Problems breathing, swallowing, or speaking
- Compression of the airway
- Excessive bone growth
- Impinged nerves
- Chronic pain in the back, arms, and legs
- Nerve damage
- Male sterility
- Need for emergency surgery
- Disability
- Death
FDA Warning for Bone Graft Substitutes in Children
January 21, 2014 — Federal health officials are warning against the use of bone-graft substitutes in kids, including products like Medtronic Infuse. The FDA is concerned that bioengineered bone-growth products containing synthetic peptides or recombinant proteins could cause excessive bone-growth.
In children undergoing spinal surgery, this could lead to nerve damage, chronic pain, weakness, and other complications. Despite the risks, a study published in 2012 found that 10% of spinal fusion surgeries in children used bone-graft substitutes. Click here to read more.
Cardiff Anterior Cervical Plate System Problems
The Cardiff Anterior Cervical Plate System (or “ACP System) is a metal plate that is used during spinal fusion surgery. The plate is screwed into a patient’s vertebrae to stabilize the bones after surgery. SeaSpine recalled the ACP System in April 2010 after receiving reports from people who were seriously injured. The FDA has received at least 13 reports of complications, including 11 reports before the products were taken off the market.
Cardiff ACP System complications can include:
- Bone screws backing out
- Locking mechanism may not lock properly or sit naturally in the locking position
- Screw variability
- Clips may bend or break during functionality testing
- Bone screw angulation
- And more
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