Medtronic Infuse Bone Graft

For patients with degenerative disc disease, a spinal fusion procedure can provide welcome relief from back pain. Many patients underwent surgery to have an infuse bone graft procedure for spinal fusion. However, many of those surgeries were for off-label use, and not FDA-approved treatments.

Thousands of patients have filed claims against Medtronic related to infuse bone graft device injuries. If you suffered pain or adverse effects from the medical device, contact an attorney with experience in Medtronic infuse bone graft lawsuits.

What Is the Medtronic Infuse Bone Graft?

The Infuse Bone Graft/Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in patients with degenerative disc disease (DDD) at spinal levels from L2 to S1. The medical device is not recommended for patients with known hypersensitivity to certain proteins and components. This should not be used in patients who are skeletally immature, pregnant women, or with an allergy to titanium or titanium alloys.

The U.S. Food and Drug Administration (FDA) approved the Medtronic Infuse system for anterior lumbar interbody fusion (ALIF). However, Infuse was frequently used for off-label procedures. In one study, researchers found that of 177 spinal fusions, Infuse was used on-label for seven procedures and off-label for 170 procedures.

Some examples of the off-label procedures include:

• Cervical anterior, posterior, and 360 fusions
• Thoracic/lumbar fusion
• Posterior lumbar fusion
• Thoracic/lumbar laminectomy
• Transforaminal interbody lumbar fusion

Thousands of plaintiffs have filed lawsuits against Medtronic for allegedly marketing the medical product for off-label use. Some state attorneys general have also filed lawsuits against Medtronic, alleging fraudulent practices. Even the U.S. Department of Justice investigated Medtronic for illegal kickbacks.

What Is Degenerative Disc Disease?

Degenerative disk disease (DDD) is damage to the spinal bones over time. As you age, the protective discs between the vertebrae can wear down and shrink. This can result in arthritis, disc herniation, or spinal stenosis. Pressure and damage to the spinal cord and spinal nerves can cause severe pain and limit range of motion.

The vertebra of the spine is made up of 33 bones. The bones are divided, from the top of the spine at the neck to the end of the lower spine, as follows:

• Cervical (C1 to C7)
• Thoracic (T1 to T12)
• Lumbar (L1 to L5)
• Sacrum (S1 to S5)
• Coccyx

Degenerative disc pain can vary, based on the individual. Pain can be expressed as nagging, underlying pain, or flare-ups of severe pain. It can also cause pinched nerves and radiating pain from the neck, down the back, and even into the arms and legs.

Physical therapy, medication, and lifestyle changes can help some patients. Other patients require spinal steroid injections. For chronic pain, treatment options include spinal surgery. Spinal surgery stops the movement of the injured segment of the spine. Surgery can also decompress the spinal nerves.

Spinal fusion surgery joins bones of the vertebrae together to stabilize the spine. A spacer cage is inserted into the collapsed disk space during surgery. The cage has bone graft, to fuse the vertebrae together over three to six months. Surgery can also use metal rods to immobilize the area while the graft fuses.

What Are the Side Effects of a Medtronic Infuse Bone Graft Treatment?

There are general risks and side effects of spine surgery, spinal fusion, and Medtronic Infuse treatments. Some medical studies have suggested the use of Infuse has higher rates of:

• Hematomas/seromas
• Nerve damage
• Soft-tissue swelling
• Ectopic bone growth
• Vertebral osteolysis

There is also a high re-operation rate, which requires patients to undergo additional surgery. Any unnecessary surgery introduces additional risks to patients, including surgical infection, anesthesia injuries, or left-behind foreign objects.

Spinal fusion treatment can also put greater stress and load on the vertebrae above and below the fused discs. This can increase the rate of degeneration in those vertebrae, leading to continuing and evolving pain. Patients may also require additional surgeries to repair the degenerating discs.

Can You File a Defective Device Claim After a Bone Graft Injury?

Patients can file a product liability claim against a manufacturer for putting out a dangerous product. Dangerous drug and defective medical device claims include:

• Defective designs
• Defects in the manufacturing process
• Failure to warn

If a medical device company is marketing its device for an unapproved use, patients may not have the information they need to make an informed medical decision. The FDA procedures for clinical trials, side effects, and adverse events relate to on-label use. The extensive off-label use of this device left many patients suffering unexpected side effects.

How Can a Defective Medical Device Attorney Help?

A defective medical device lawsuit can hold the medical device manufacturer accountable for their defective products. A medical malpractice or product liability lawsuit can help you secure compensation for:

• Medical bills
• Loss of income
• Costs of additional surgery
• Pain and suffering

If a loved one dies because of injuries related to spinal graft surgery, you may be able to file a wrongful death lawsuit. A wrongful death claim allows family members to get compensation for loss of financial support, loss of benefits, and funeral expenses. To understand your legal options, contact a bone graft personal injury attorney.