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Medtronic Infuse Offers Lots (and Lots) of Risks, and No Clear Benefit

Sep 19, 2013

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Stanford University recently published a study in The Journal of Bone & Joint Surgery regarding the relationship between cancer and Medtronic’s Infuse bone grafting product – which uses a genetically engineered protein called rhBMP-2 to help re-grow bone in the spine, removing the painful need to “harvest” bone from the patient’s own iliac crest.

In sum, the study reveals that a large dose of Medtronic’s Infuse bone graft – 40 mg or more – used in a spinal fusion is enough to cause an increased risk of cancer.

The study used publicly available data from patients with degenerative lower spine conditions who underwent a spinal fusion either using a high dose of Medtronic’s rhBMP-2 or a traditional bone graft, which uses bone harvested from the patient’s own body. The risk of new cancers in each group was noted at two and five years after surgery. At the two-year mark, with 86% follow-up, there were 15 new cancer cases in 11 members of the rhBMP-2 group, while the traditional bone graft group experienced only two new cancers in two patients. At five years, there was again a significantly larger occurrence of cancer seen in the rhBMP-2 group.

Medtronic’s Infuse product has already been linked to cancer – that and a host of other serious adverse events.

Even before the Stanford study and its revelations, two independent studies overseen by Yale University reveal important key findings regarding Medtronic’s Infuse product – namely, that it can result in a litany of harmful, if not fatal, side effects, including retrograde ejaculation, pain and extraneous bone growth, as well as cancer. The results of those studies were published in the June edition of the medical journal Annals of Internal Medicine.

The Yale study’s bottom line is that, in addition to the various adverse events waiting to happen to those implanted with Medtronic Infuse, there is little, if any, difference in the actual effectiveness of Infuse over a traditional bone graft. Meaning in the face of all this risk, there are no clear advantages to Infuse versus harvesting bone for a spinal fusion the traditional way.

But there are other problems with Medtronic Infuse: namely, the off-label use of the product, which is also host to a variety of negative side effects.

The U.S. Food and Drug Administration (FDA) approved Medtronic Infuse in 2002 – specifically for lower spine surgeries in which the surgeon operates on the patient by going in through the front of the body. Infuse was never approved for use on the upper, or cervical, spine, where it has been widely used nevertheless. The consequences of using Medtronic Infuse off-label on the upper spine are so perilous, the FDA issued a safety alert in 2008 outlining the various complications that could result from this off-label procedure: excessive swelling in the neck, compressed airway, difficulty breathing, problems swallowing and nerve damage. Specifically, the FDA noted that it had received reports of “life-threatening complications associated with” Infuse when it was used off-label, in the cervical spine. The agency reiterated that “these products are not approved by FDA for this use.”

One has to wonder: If there is, essentially, no benefit to having a spinal fusion that utilizes Medtronic’s Infuse bone grafting product, and if there is a greater risk you’ll develop cancer if your doctor uses the device in the approved way (never mind what can happen to you via off-label usage), then why does the FDA continue to allow this product to exist on the market?

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