Medtronic Accused of Concealing Critical Safety Data for Infuse

When Medtronic’s Infuse Bone Graft was first approved by the FDA in 2002, the innovation was hailed as a major breakthrough that could stimulate the formation of new bone mass when used in spinal fusion procedures. Medtronic’s own website waxed poetic about the breakthrough, comparing it to The Anatomy Lecture of Dr. Nicolaes Tulp – a 1632 masterpiece by Rembrandt.

Medtronic’s website also insists that the Infuse Bone Graft has been demonstrated to be safe based on its “10 years of approved market utilization.”

A recent report published by the Star Tribune suggests that this may not necessarily be the case.

Two-year adverse event study

The investigative report discusses the documentation of adverse events from 3,600 patients who had received the Infuse Bone Graft. This documentation effort was conducted by Medtronic’s own employees over a two-year time period. The biotech company was interested in hearing directly from doctors about issues that their patients had experienced.

Some of these issues were relatively minor, while others were quite serious. Four of the patients had lost their lives after receiving the Infuse Bone Graft. Instead of taking action, suggests the Star Tribune, Medtronic shut down the study in the spring of 2008.

“I feel duped”

If the allegations are true, it would mean that Medtronic failed to report possible adverse events to the FDA, which they would have been required to do within 30 days of learning of them. Upon hearing of these allegations, Dr. Charles Rosen lamented his use of Infuse on many of his patients. “I, for one, feel duped,” said the California surgeon, who is also the co-founder of the Association for Medical Ethics.

In a meeting with the investigative reporters from the Star Tribune, executives from Medtronic acknowledged the failure to promptly report adverse events and blamed the problem on an internal misfiling issue. Medtronic executives further claimed that the results of the informal study were indeed reported to the FDA after the data were discovered more than five years after they were misfiled. Medtronic claims that no patients suffered harm as a result of the delayed disclosure and that internal procedures at the biotech company have since been improved.

FDA disclosures

After Medtronic had submitted data to the FDA about the 1,000-plus Infuse Bone graft problems, the FDA later released an extremely brief summary of the data to the public. The agency blacked out the total number of events from this three-sentence summary. The Star Tribune was only able to acquire this data after challenging the FDA’s decision not to disclose it.

Uses of Infuse Bone Graft

The Infuse Bone Graft consists of synthetic concentrated proteins called recombinant human bone morphogenetic proteins (rhBMP-2). In 2002, it obtained FDA approval for a very limited purpose: Anterior lumbar interbody fusion spine surgical procedures that also used Medtronic’s LT-CAGE Lumbar Tapered Fusion Device, known as the Inter Fix Threaded Fusion Device. Furthermore, the approved use was only for skeletally mature patients with degenerative disc disease. Since then, the company has obtained FDA approval for the graft’s use in treating tibial shaft fractures and for its use in sinus augmentation procedures.

However, some critics have questioned the widespread use of Infuse Bone Grafts for a range of other surgical procedures. A study in the journal Spine suggested that at least 85 percent of the 340,000 surgeries performed in the U.S. between 2003 and 2007 that used Infuse Bone Graft were for purposes that had not been reviewed by the FDA for safety or effectiveness. This data is likely to add fuel to the fire regarding recent litigation against Medtronic.

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