This Controversial Medtronic Spine Treatment Was Put In The Spotlight By June 2011 Medical Journal Articles About Serious Risks And Problems With Infuse

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Medtronic bone graft has limited benefit, may cause harm: reviews"  (6/17/13, Reuters)

"Reviewers: Medtronic's controversial Infuse offers little to no benefit"  (6/17/13, Minnesota Public Radio)

(6/18/13)

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The Medtronic Infuse Bone Graft product was under some scrutiny even before the June 2011 edition of The Spine Journal, which was a special issue containing articles that challenged earlier published research backing the widespread use of Infuse.  Among the various problems revealed in those articles was that several clinical studies of the Infuse failed to report serious complications that arose in the device clinical trials.  Further compounding this situation was the somewhat veiled fact that those Infuse clinical trials were conducted by surgeons with strong economic ties to Medtronic.

In response to this special "Infuse issue" of The Spine Journal, Medtronic gave a $2.5 million grant in August 2011 to Yale University to conduct an independent review of all clinical study data that examined the effectiveness and safety of the Infuse Bone Graft product.  The plan for this Yale study review was developed by Harlan Krumholz, M.D., a prominent cardiologist who has been outspoken about the need for full disclosure by drug and medical device companies about their products so that doctors and patients can make decisions based on full knowledge of the risks and benefits of those products.

From the Yale School of Medicine web site:

Medtronic Research Grant to Yale University Establishes New Model for Independent Analysis and Dissemination of Industry Data

Medtronic, Inc. has provided a grant to Yale University to apply the YODA Project model in practice for the first time. Yale will lead independent, systematic reviews of the entire body of scientific evidence regarding the safety and effectiveness of Medtronic’s recombinant bone morphogenetic protein-2 (rhBMP-2) product. The reviews will be conducted independently by two academic teams with full access to all Medtronic’s clinical trial, post-marketing and safety data about rhBMP-2. The results of the reviews are anticipated to be released June 2013.

In addition, the grant supports the dissemination of all Medtronic clinical research data on rhBMP-2 to external investigators, which is also expected for June 2013.

But there is much more involved with the Medtronic Infuse Bone Graft safety issue, a subject which we will be focusing on over the next couple of months leading up to the scheduled release of this Yale Infuse study.

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As a preview, during this Medtronic Infuse series of articles we will be covering:

• Investigative news reports looking into the serious medical complications and side effects associated with the Infuse Bone Graft that were essentially ignored in Medtronic-funded studies;
• A U.S. Senate Finance Committee investigation led by Senators Charles Grassley and Max Baucus concerning the revelations made by those press reports as well as The Spine Journal June 2011 edition featuring the Infuse safety issues;
• A U.S. Justice Department investigation looking into the reportedly 85% "off-label" use of the Medtronic Infuse Bone Graft product, i.e., its use for procedures beyond those officially approved by the FDA, with an emphasis on the allegation that Medtronic actively promoted off-label use of Infuse; and,
• Lawsuits being filed against Medtronic on behalf of patients who have suffered ectopic / excessive / unwanted bone growth, neurological impairment, and other severe side effects of the Infuse Bone Graft product.

In summary, from these several perspectives, during this special series of articles we will examine the serious risks associated with the so-called "blockbuster" Medtronic Infuse Bone Graft product.

Of course, if you have any tips or tidbits about the Infuse Bone Graft which you think deserve more attention, please send them to me by email for consideration to be included in one of these upcoming Infuse articles here on Drug Injury Watch.

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