Medtronic’s bone graft product, InFuse, is a synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2) that was approved by the U.S. Food & Drug Administration (FDA) in 2002 for specific uses.
Meant to stimulate spine growth in patients suffering from lower spinal degenerative disease, InFuse is approved for use in one type of spinal surgery and some dental procedures. InFuse is not approved for use on the upper, or cervical spine, where it is now widely used in off label procedures. On July 1, 2008 the agency issued a notification warning that InFuse had been associated with serious complications when used in cervical spinal fusions.
As we have long explained, it is illegal for Medtronic, or any device or drug maker, to market a product for uses not approved by the FDA, although physicians are free to prescribe device and drugs for off label purposes.
Infuse has been associated with an array of adverse reactions, including:
- Bone dissolution
- Cauda Equina Syndrome (“Horse Tail” Syndrome)
- Compressed airways
- Difficulty swallowing, breathing, and/or speaking
- Gastrointestinal Problems
- Excessive swelling in the neck
- Increased cancer risks
- Male infertility, sterility
- Nerve injuries and nerve damage
- Pain, chronic pain
- Retrograde ejaculation
- Swelling of the neck resulting in injury or death
- Uncontrolled bone growth
- Worsened back and leg pain
The way in which Medtronic marketed InFuse has been the subject of fierce controversy. For instance, there are concerns over how research was conducted for InFuse, which was Medtronic-funded. Medtronic has also been accused of touting Infuse off label and of downplaying the device’s risks while overstating its benefits. As a result, Medtronic and InFuse have been the subject of a Senate probe, in addition to the FDA warning and independent studies.
The Senate investigators charged that Medtronic intentionally influenced studies to downplay adverse reaction data associated with InFuse, while touting its off label uses. The U.S. Senate Finance Committee found issues with most of the initial Medtronic-supported InFuse research that was used to promote the bone graft product. Also, a special 2011 publication of The Spine Journal was devoted to reports that critiqued InFuse research conducted by surgeons who received millions of dollars from Medtronic and accused Medtronic of not reporting serious complications associated with InFuse.
The two independent and recently published studies revealed that InFuse is not any better than traditional, patient-harvested bone grafting and is also associated with serious adverse events, including increased cancer risks.
Despite all this, Medtronic continues to market InFuse and has not implemented a recall. Most patients and physicians are unaware of the notorious history connected to Medtronic’s InFuse and that traditional bone grafting—in which bone is patient harvested—is an option. Meanwhile, InFuse remains on the market and continues to be used in surgical procedures.