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Medtronic INFUSE Bone Graft Off-Label Complications

Posted on December 20th, 2011 by Robert D. Rowland

It is estimated that 900,000 patients may have used the Medtronic INFUSE Bone Graft, a medical device with an active ingredient, rhBMP-2, that’s described as “a “genetically engineered version of a naturally occurring protein that is capable of initiating bone growth in specific, targeted areas of the spine.”

In 2002, the Food and Drug Administration approved INFUSE for only one type of spine surgery – anterior approach lumbar fusion. It has not been approved for any other type of spine surgeries, such as lateral or posterior approach lumbar fusion surgeries, or for surgery on the neck or cervical spine (the portion of the spine that runs from the shoulders to the head).

Despite its limited authorized use, INFUSE has been used off-label in surgeries on the lumbar or cervical spine for many patients. Today, as much as 85% of INFUSE use is off-label. In cases like these, when any drug or medical device is used off-label, the surgeon must fully disclose any and all risks prior to the surgery, so that the patient may make an informed decision as to whether or not to proceed with the surgery.

In June of 2011, a medical journal called The Spine Journal criticized earlier studies by physicians with financial ties to Medtronic that supported the widespread use of INFUSE. The Spine Journal charged “biased and corrupted research,” alleging the studies greatly understated INFUSE’s serious side effects and risks. In fact, in none of the 13 trials funded by Medtronic were any adverse events disclosed.

U.S. regulators and other research has now shown that up to 50% of patients who have received an INFUSE implant have suffered adverse effects, including ectopic bone growth, uncontrolled bone growth, swelling in the neck and throat, infection, inflammatory cyst formation, cancer, and infertility in men.

Have you or a loved one suffered side effects after receiving an INFUSE implant? Contact Robert D. Rowland.