Surgical Device Company Failed to Report Its Spinal Implant Causes Cancer

Surgical device company Medtronic paid surgeons millions of dollars to investigate the safety of their spinal implant products. Turns out they cause cancer, but no one reported it.

So the Milwaukee Journal-Sentinel did! They tell the disturbing story in an exhaustive investigative article. The devices in question, called Infuse and Amplify, are used in spinal fusion surgery. Surgeons wedge the devices between vertebrae to correct back irregularities including scoliosis, kyphosis, disc herniation, vertebral fracture and many others. Before the Medtronic devices, patients had to undergo an extra surgery to get replacement bone from their hip or they received donor bone. Infuse and Amplify eliminate that requirement with bone-growth-stimulating proteins. Revenue from Infuse has been about $700 million annually since coming on the market in 2002 (The FDA has declined approval of Amplify, and Medtronic is contesting the decision).

The author of the Journal-Sentinel article, John Fauber, recruited a physician researcher and sifted through 1,000 pages of FDA documents for his investigation to find that the bone-growth protein, called bone morphogenetic protein-2, is not as safe as Medtronic led folks to believe. Even though the surgeons claimed in a 2009 paper there was no significant link between the product and cancer, there totally was.

Failure to report the cancer could easily be attributed to a conflict of interest: For research that led to the 2009 paper, Medtronic paid investigators more than $10 million dollars to study Amplify's safety and effectiveness.

The 2009 paper on the trial was written by six physician authors. The first three authors of the paper - or entities they are associated with - received about $10 million from Medtronic, mostly in royalties, in 2010 alone. The royalties were for other products, not for BMP-2.

Two of the other authors received no compensation from Medtronic in 2010. Another author received between $5,000 and $9,999 for advisory services to the company.

It's bad news for Medtronic, which produces a variety of medical devices including pacemakers, implantable gadgets that thwart seizures, and many other gizmos for facilitating surgery. But it's way worse news for spine patients.

[Milwaukee Journal-Sentinel via Knight Science Journalism Tracker; Image: Medtronic]


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