Karina Basso  |  January 21, 2015

Category: Legal News

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spine surgery doctorMedtronic Inc.’s Infuse Bone Graft product is a popular medical device that supposedly encourages the growth of bones within the human body, particularly those in the spine.

While Infuse can be potentially beneficial to many patients suffering from back pain and other spinal complications, Infuse has come under scrutiny following reports of severe Infuse side effects.

According to various news reports and Infuse bone graft lawsuits, Medtronic’s product has been linked to instances of cancer, excess bone growth, and even male sterility. In 2013, the National Center for Biotechnical Information (NCBI) published a medical report suggesting that the Infuse bone graft system was likely to cause life-threatening problems during revision surgeries.

The Infuse report goes on to say the Medtronic bone graft product contributed to patients’ fibrosis and scarring, thus causing the iliac vein (which connects to several points along the pelvis and back body) to stick to the operation area along the patients’ spine. Should this adhesion occur, the risk of life-threatening vascular injury during a revision surgery is quite high.

Infuse side effects like vascular injury and excess bone growth become more prevalent when the Infuse bone graft product is used for off-label (that is, non FDA-approved) procedures. Off-label use of Infuse has become more and more common within the American medical community because Medtronic has allegedly bribed or paid off doctors to hide Infuse bone graft side effects.

Infuse Bone Graft Side Effects

The Medtronic Infuse bone graft is composed of a growth protein known as recombinant human bone morphogenetic protein-2 (rhBMP-2), which can stimulate bone growth. Because of this protein, Infuse became an FDA-approved treatment for anterior lumbar fusion spine surgery, a surgery performed through the front of a patient’s body.

The FDA has not approved the Infuse bone graft for posterior lumbar fusion procedures, meaning that use of Infuse for a posterior lumbar fusion surgery is considered an unapproved, off-label use.

While it is not illegal for a doctor to use a medical product like Infuse for an off-label procedure, it is illegal for a company like Medtronic to market or promote its medical device for off-label purposes.

Medical professionals and lawyers are particularly concerned with off-label use of Infuse because Infuse complications have most commonly occurred when the Medtronic product was used for an off-label procedure, such as using Infuse bone graft in the cervical spine.

Some reported Infuse side effects include:

  • Trouble swallowing
  • Trouble breathing
  • Trouble speaking
  • Cancer
  • Ectopic and/or uncontrollable bone growth near operation site
  • Nerve injuries resulting in severe, chronic pain
  • Constant, chronic pain in arms and legs
  • Male sterility (also known as retrograde ejaculation)
  • Cauda equina syndrome (CES)
  • Others

Many consumers who have filed Infuse lawsuits or joined Infuse class action lawsuits have alleged that Medtronic attempted to hide Infuse bone graft side effects and complications. Additionally, in June 2011, a group of medical experts specializing in spine and spinal surgical procedures denounced Medtronic, alleging that the company’s Infuse studies failed to detail or report product side effects, including cancer, sterility, bone dissolution, increased back/leg pain, and infection.

These same spine experts published their own study in the Spine Journal, finding that Infuse complications occurred in about 10 percent to 50 percent of patients who received an Infuse treatment. This data was gathered by this spine specialists from 13 different Medtronic-funded Infuse trials running from 2000-2010.

Because of the number of allegations brought forth in opposing Infuse research and by consumers in Infuse bone graft lawsuits, a consolidated class action lawsuit has been established in Minnesota federal court against Medtronic Inc. The company has attempted to dismiss this Infuse bone graft class action lawsuit, but the motion was denied by the judge.

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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