Medtronic researchers sugar coated bone graft results
  • Tue, 07/31/2012 - 12:30pm

In 1999, reports about a breakthrough bone graft product started a commotion when clinical trials went awry. 

The spinal surgery device was intended to grow bone and to help stabilize the spine through fusion of the vertebrae.  However, according to MedPage Today, “Only a few months into the clinical trial of the Medtronic bone morphogenetic protein-2 product known as Infuse, CT scans revealed that unwanted bone had formed in the spinal canal of 70 percent of those who got the substance.”

The trial was supposed to include hundreds of participants suffering from degenerative disc disease, but due to disastrous results, it was terminated after Infuse was implanted in a mere 34 participants.

Once the clinical was halted, it took five years before spine surgeons published paperwork on the study’s unexpected results. Even then, they downplayed the adverse side effect.

“Even though bone formed, no negative outcomes were found,” they wrote.

However, MedPage Today reported that Medtronic knew of two cases in which patients suffered such severe pain from the bone overgrowth that they had to undergo additional surgery.

According to the website, Tulsa, Oklahoma surgeon David Malone said, “It grew back even larger than the first time.”

The original published paper acknowledged that some patients underwent further surgeries following the trial but did not attribute ectopic bone growth as the cause.

“If we can’t trust the scientific medical literature to be accurate, we can’t provide the best patient care,” a physician and professor at Oregon Health and Science University reportedly said.

Two years before the spinal surgeons’ paper was published, Malone sent a letter to the FDA with information regarding the clinical trial and the ectopic overgrowth with Medtronic’s Infuse implants. The FDA went on to approve Infuse based on another clinical trial that utilized a different surgical method, according to MedPage Today.

Years later, in 2008, a group of doctors in Denver found neurological impairment due to ectopic bone forming in the spinal canal of five patients who'd been implanted with Infuse.


About the Contributor

Kaitlin Gill
I report on news regarding product safety concerns for individuals and families.

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