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Medtronic Infuse Off-Label Use


Many people who received Medtronic Inc.’s Infuse bone graft in off-label procedures have suffered severe, life-threatening injuries following their surgeries. Infuse bone graft has ONLY been approved for a type of spine surgery called anterior approach lumbar fusion, and two dental surgeries. However, it is known that Infuse has been widely used off-label in spinal procedures where the U.S. Food & Drug Administration (FDA) has not approved its use, including cervical (neck) spine surgery, lateral approach (through the side of the body) spine surgeries, and posterior approach spine surgery. Unfortunately, many patients who underwent an off-label Infuse procedure have experienced disastrous complications.

A new potential adverse side effect of Medtronic’s Infuse bone graft product—whether in use on- or off-label—was recently revealed. In November 2013, the National Center for Biotechnology Information (NCBI) posted on its website a report revealing that Medtronic’s Infuse was found to have been the likely cause of a life-threatening problem during a revision surgery. Specifically, the report blamed Infuse for partially contributing to fibrosis and scarring, which caused the patient’s iliac vein to adhere to the area of the spine that had been previously operated on. The result: a life-threatening vascular injury during revision surgery.

“Spine surgeons should be aware of this potential inflammatory fibrosis in addition to other reported complications related to [Medtronic’s Infuse],” the authors noted.

If you or a loved one suffered a serious injury following surgery with the Medtronic Infuse bone graft, you may be able to seek compensation through a lawsuit. The Medtronic Infuse injury lawyers at Parker Waichman LLP are currently offering free lawsuit evaluations to anyone injured as a result of the off-label use of this product. If you or a loved one would like to discuss such a lawsuit, we urge you to contact one of our Medtronic Infuse lawyers today.

Medtronic Infuse Off-Label Use Injuries


The FDA first issued a warning about Medtronic Infuse in 2008, after it had received dozens of reports of side effects linked to off-label Infuse procedures, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

Medtronic Research


Research indicates that at least 85% of Infuse use is now off-label. According to a 2008 report from The Wall Street Journal, at least 280 reports of side effects involving Infuse had been made to the FDA since Medtronic Infuse was first brought to market. About three-quarters of those reports involved off-label use. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufacturers to market products based on such uses. Unfortunately, off-label use of Medtronic Infuse can have serious consequences for some patients. Injuries and side effects linked to inappropriate use of Infuse include:

  • Acute severe swelling of the neck several days after surgery, resulting in death or permanent injury
  • Cancer – may types including stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, pancreatic
  • Difficulty swallowing
  • Difficulty breathing
  • Difficulty speaking
  • Ectopic or uncontrolled bone growth at or near the site of the surgery (a study found that 75% of Infuse patients experienced ectopic bone growth)
  • Nerve injuries causing severe and chronic pain
  • Ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis)
  • Male sterility (Independent researchers at Stanford University found evidence that Infuse was linked to a complication that causes sterility in men)
  • Retrograde ejaculation, or other uro-genital injuries in male patients.

Legal Help for Victims of Medtronic Infuse

If you or a loved one suffered serious or life-threatening complications following off-label use of the Medtronic Infuse bone graft, you may have valuable legal rights. To discuss your case with one of our Medtronic Infuse lawyers, please fill out our online form, or call 1-800 YOUR LAWYER (1-800-968-7529) today.

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Surgeon Misconduct

LIE Congestion

Medtronic Promoted Off-Label Use of Infuse

Lawsuits allege that surgeons with financial ties to Medtronic promoted the use of Infuse unofficially in a number of unapproved settings. It has also been alleged that Medtronic downplayed many of the side effects associated with off-label use of Infuse. Medtronic's conduct in regards to the marketing and promotion of Infuse is currently being investigated by the U.S. Department of Justice, as well as the U.S. Senate Finance Committee.

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