Medtronic INFUSE® Potentially Associated with Cauda Equina Syndrome, Studies Criticized

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INFUSE® is a synthetic type of recombinant human Bone Morphogenetic Protein (rhBMP-2 or BMP2) approved for use in a one type of spinal surgery and some dental procedures. Yet BMP-2 is used off-label in 85 percent of the cases and Medicare is considering stopping coverage of BMP-2.

In these cases, instead of performing the surgery from an “anterior,” or frontal approach, BMP-2 is utilized in a rear or so-called, “posterior,” approach in the spine’s cervical area, as well as for multiple levels of the spine. The BMP-2 powder is designed to be mixed with a specific amount of water for a specific period of time; however, emerging evidence reveals that surgeons may be utilizing too much water or too much BMP-2  during off-label surgical spine procedures and that a lack of precision may be leading to injuries.

U.S. Food & Drug Administration (FDA) data has revealed that at least half of all patients treated with Medtronic INFUSE® suffered complications that include:

  • Uncontrolled bone growth
  • Male sterility
  • Retrograde ejaculation
  • Gastrointestinal problems
  • Nerve injuries
  • Cancers
  • Pain and chronic pain
  • Difficulty Swallowing, breathing, and/or speaking
  • Swelling of the neck resulting in injury or death
  • Infections
  • Cysts

The bone growth product, a sealant, can potentially drip onto the spinal cord or spinal nerves, leading to serious, severe injuries, including Cauda Equina Syndrome, which involves a serious spinal cord narrowing and in which nerve roots below the spinal cord level become severely compressed or inflamed. While several causes of Cauda Equina Syndrome are known, Medtronic INFUSE® use in off-label spinal surgery has been associated with this devastating injury, most probably from the product coming into contact with nerves and other areas of the body. Nerve root damage due to Cauda Equina Syndrome following surgery with Medtronic INFUSE® can lead to: Pain, altered reflexes, and decreased strength and/or sensation. Cauda equina syndrome is considered a surgical emergency and, if left untreated, can lead to permanent loss of bowel and bladder control and leg paralysis.

An article previously published in The Spine Journal revealed that 13 Medtronic-sponsored clinical trials of INFUSE® failed to report serious complications in patients treated with the product. The report raised concerns about the financial ties between Medtronic and the researchers who conducted the 13 studies, prompted a U.S. Senate Committee investigation of Medtronic’s financial ties to INFUSE® researchers, and confirmed that Medtronic paid hundreds of millions of dollars to influence clinical data on the bone growth product.

“This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Dr. Harlan Krumholz, a professor of medicine at Yale University, told MedPage Today when he was told of the government report. “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit. It’s no wonder the public has lost confidence in the drug and device industries,” Krumholz added. Krumholz, who is in charge of a Yale review of INFUSE®, was described by Forbes magazine as “the most powerful doctor you never heard of.”