Infuse Bone Graft
The FDA approved Medtronic’s spinal surgery product Infuse in 2002 for a very limited application. Infuse was originally approved for use in a lower back surgery called a lumbar fusion and was later granted approval for use in two different types of dental surgeries. Unfortunately the product was commonly used off-label, which has had dangerous implications for consumers.
The Infuse bone graft contains recombinant human Bone Morphogenetic Protein (rhBMP), which stimulates bone growth and bone formation. It is a genetically modified version of a protein that is normally found in someone’s body.
Patients who have received this product have experienced these adverse side effects:
- Excessive bone growth
- Bone resorption (Dissolution of mineral crystals and breakdown of bones)
- Inflammation, specifically inflammation of the airways and neck
- Back and leg pain
- Neurological Problems
- Retrograde ejaculation
- Urinary retention
These side effects were not well known because they were underreported or unreported in clinical studies. In 2011 The Spine Journal examined 13 studies that promoted Infuse. These studies failed to report serious side effects, even though they were supposed to be peer reviewed. The Spine Journal estimated that adverse events occur at 10 to 50 times the original estimates.
Not surprisingly the authors of these 13 studies had significant financial ties to Medtronic. These financial ties have come under increasing scrutiny as it becomes clear that Medtronic may have manipulated the studies.
According to Medtronic, Infuse has been used for treatment in over a half million patients nationwide. The New York Times noted that in 2010 Medtronic had $15.9 billion in sales and while they do not report on specific products, Infuse has been one of their best sellers.
TorHoerman Law is actively investigating claims that Infuse caused serious medical complications.