Ashley Milano  |  December 24, 2014

Category: Legal News

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infuse bone graft spinal surgery

Medtronic Infuse is a bone-growth protein that is used in spinal fusion surgery and has been linked to severe, life-threatening side effects, including sterility, nerve damage, and cancer.

One of the most common Infuse bone graft complications is excessive bone growth, which can cause severe nerve damage and other side effects. Medtronic is facing lawsuits over allegations the company paid researchers millions of dollars to produce research that minimized the risks of the Infuse.

What is the Infuse Bone Graft?

The Medtronic Infuse bone graft is a medical device that is intended to be implanted after lower-back (lumbar) spinal surgery. It works by stimulating bone growth in this area.

It was developed as an alternative to traditional bone graft procedures, which involve either the use of bone harvested from the hip or another part of the body, or bone extracted from dead bodies.

The device itself consists of two parts — a sponge-like substance, which is soaked in a biological agent. The biological agent is a synthetic liquid form of bone morphogenetic protein, or BMP.

The device is implanted between vertebrae, and the BMP stimulates the bones to grow. The sponge dissolves and is absorbed into the body.

Although it was only tested and approved for use during anterior lumbar fusion, involving single-level fusion, the Infuse bone graft has been widely used off-label in other spinal surgery, including cervical fusion, thoracic fusion, posterior lumbar fusion (where the lumbar spine is approached from the back instead of through an incision in the abdomen, as is done during an anterior lumbar fusion), as well as during multi-level fusions.

Infuse Bone Graft Side Effects

When used during these unapproved procedures, Medtronic Infuse side effects may cause bone growth in areas where it is not wanted, which may cause:

  • Severe inflammatory reaction
  • Airway compression or breathing problems
  • Nerve impingement resulting in severe back or neck pain
  • Hospitalization with treatment in ICU
  • Need for a feeding tube or tracheotomy
  • Additional surgery to remove excessive bone from the spinal canal
  • Death

Research has also suggested that use of Medtronic Infuse may increase the risk of cancer, as well as cause some men to become sterile.

Medtronic Infuse Bone Graft Lawsuits

Although Medtronic was allegedly aware of risks associated with off-label use, the company has been accused of widespread over-promotion of the Infuse bone graft, encouraging use during spinal fusion surgery that was never properly studied and was known to cause serious side effects.

Medtronic is also accused of engaging in illegal “off-label” promotion of the Medtronic Infuse bone graft. The U.S. Department of Justice (DOJ) has begun a criminal investigation, and the company is currently facing a Congressional investigation. Medtronic admitted to paying a surgeon nearly $800,000 to falsify study information, which produced a favorable review of the Infuse bone graft, all while downplaying the risks of severe side effects.

Patients who suffered from Medtronic Infuse problems after undergoing a cervical spine surgery with the product may have legal recourse to receive financial compensation for damages.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Join a Free Medtronic Infuse Class Action Lawsuit Investigation

An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.