Medtronic Infuse Bone Graft Lawsuits in Syracuse, New York

The Medtronic Infuse Bone Graft system was marketed as a breakthrough alternative to traditional bone grafts for spinal fusion surgery. However, thousands of patients have suffered severe complications from this defective medical device, including ectopic bone formation, chronic pain, neurological damage, and failed spinal fusions. If you were injured by Medtronic Infuse, our experienced Syracuse Medtronic Infuse lawsuit attorneys at Gillette & Izzo can help you recover compensation.

Call 315-421-1000 today for a free consultation with a spinal implant injury lawyer who understands the devastating impact of failed spinal surgeries.

What Is Medtronic Infuse Bone Graft?

The Medtronic Infuse Bone Graft system uses recombinant human bone morphogenetic protein-2 (rhBMP-2) to promote new bone growth in spinal fusion procedures. The FDA approved Infuse in 2002 for specific “on-label” uses with the LT-Cage in anterior lumbar interbody fusion (ALIF) procedures.

However, according to research published by the National Institutes of Health, Medtronic aggressively marketed Infuse for “off-label” uses in cervical spine surgery, posterior lumbar fusion, and other procedures for which it was never approved. More than 1 million patients have received Infuse bone grafts, with many experiencing serious complications.

Medtronic Infuse Complications and Side Effects

Patients who received Medtronic Infuse bone grafts have reported devastating complications:

Ectopic Bone Formation

One of the most serious problems with Medtronic Infuse is abnormal bone growth outside the intended fusion site. According to medical research, this “ectopic ossification” or “heterotopic bone formation” can cause:

• Spinal canal narrowing (stenosis) compressing nerves

• Nerve root compression causing radiating pain, numbness, and weakness

• Radiculitis and radiculopathy with chronic leg and arm pain

• Myelopathy (spinal cord compression) causing paralysis

• Need for additional surgery to remove excess bone growth

Research from Stanford University linked Infuse to life-threatening complications in cervical spine surgery, including extreme neck swelling resulting in permanent injury and death.

Failed Spinal Fusion (Pseudarthrosis)

Ironically, despite being designed to promote bone fusion, many patients experience fusion failure with Infuse:

• Pseudarthrosis (failure of vertebrae to fuse properly)

• Implant displacement and subsidence (sinking into vertebrae)

• Graft dislodgement requiring revision surgery

• Spinal instability and chronic pain

According to NIH research, the actual incidence of adverse events attributed to Medtronic Infuse is between 10% and 50% depending on the procedure—far higher than Medtronic originally disclosed.

Neurological Complications

Patients have reported severe nerve damage from Medtronic Infuse:

• Chronic back and leg pain (radiculitis)

• Numbness and tingling in extremities

• Muscle weakness affecting mobility

• Bowel and bladder dysfunction from nerve compression

• Permanent neurological deficits

• Paralysis in severe cases

Male Reproductive Complications

Research has linked Medtronic Infuse to urogenital problems in men:

• Retrograde ejaculation (semen enters bladder instead of exiting penis during orgasm)

• Male sterility and fertility problems

• Urinary incontinence

A Stanford University study found these complications occurred at significantly higher rates than Medtronic disclosed.

Life-Threatening Complications from Cervical Use

The FDA issued warnings about using Medtronic Infuse off-label in cervical spine surgery, noting risks of:

• Severe neck swelling compromising the airway

• Difficulty swallowing (dysphagia)

• Difficulty breathing requiring emergency intubation or tracheostomy

• Difficulty speaking

• Hematoma and seroma formation

• Life-threatening inflammation

• Death

According to the FDA, complications from cervical use can occur between 2 and 14 days following surgery, requiring immediate medical attention.

Other Serious Complications

Additional Medtronic Infuse complications include:

• Increased cancer risk with higher BMP-2 doses

• Osteolysis (bone destruction) around the implant

• Infection at the surgical site

• Inflammatory reactions causing tissue damage

• Arachnoiditis (spinal membrane inflammation)

• Implant subsidence into weakened bone

Medtronic’s Concealment of Safety Data

In 2011, research published in The Spine Journal revealed that Medtronic manipulated safety data in industry-sponsored clinical trials. According to NIH research, Dr. Eugene Carragee and colleagues found that 13 of the original Infuse studies failed to acknowledge multiple adverse events.

The research uncovered:

• Originally unpublished adverse events hidden from the medical community

• Internal inconsistencies in clinical trial data

• Exaggerated reports of complications from traditional bone grafts to make Infuse appear safer by comparison

• Downplaying of serious complications like retrograde ejaculation, ectopic bone formation, and cancer risk

• Failure to report life-threatening events associated with cervical spine use

According to the findings, investigators observed “biases that favored study vs. control patients” and noted that adverse event rates were significantly understated.

Off-Label Marketing of Medtronic Infuse

While the FDA approved Medtronic Infuse only for specific anterior lumbar fusion procedures, Medtronic heavily promoted off-label uses. According to medical literature:

• Approximately 85% of Infuse usage was “off-label” for unapproved procedures

• Medtronic paid physicians consulting fees to encourage off-label use

• The company downplayed significantly higher complication rates for off-label procedures

• Cervical spine surgery with Infuse showed 40% risk of adverse events, including life-threatening complications

What Compensation Can a Medtronic Infuse Lawsuit Recover?

Patients injured by Medtronic Infuse bone grafts may be entitled to substantial compensation. Our Syracuse Medtronic Infuse attorneys pursue:

Medical Expenses

• Revision surgery to remove excess bone growth or replace failed fusion

• Extended hospitalization for complications

• Chronic pain management (medications, injections, implants)

• Physical therapy and rehabilitation

• Neurological treatment for permanent nerve damage

• Future medical monitoring and care

Lost Wages and Income

• Time off work for multiple surgeries and recovery periods

• Lost income during extended disability

• Reduced earning capacity if nerve damage prevents returning to previous work

• Permanent disability benefits

Pain and Suffering

• Chronic pain from failed fusion or nerve damage

• Emotional distress from multiple failed surgeries

• Depression and anxiety from permanent disability

• Loss of enjoyment of life and inability to participate in activities

• Loss of consortium (impact on marriage and family)

Punitive Damages

Given Medtronic’s alleged concealment of safety data and manipulation of clinical trial results, courts may award punitive damages to punish this egregious misconduct.