The Medtronic Infuse bone graft has a colorful history from beginning to wherever it ends. For many patients who received the product, the story will never end.
After filing for approval for their Infuse bone graft product in January 2001, Medtronic received expedited review status from the FDA. In July 2002, they were approved to use the Infuse bone graft for an anterior approach lumbar fusion. In just 1.5 years this product went from approval filing to approval. Hence, possibly the reason for the limited usage approval.
Herein begins a story of illegalities, corruption, dishonestly, and much pain and suffering:
In 2004, Medtronic begins promoting off-label use of the Infuse Bone Graft System. If you are not familiar with off-label use, this is not an uncommon practice. It is not uncommon that pharmaceutical and other medical manufacturing entities will promote an off-line use in order to boost sales and profits. However, there are certain lines that should not and must not be crossed. This is where the plot thickens.
The Infuse product was not approved for any spine surgery except the anterior approach lumbar fusion. It was NOT approved for others such as a lateral/posterior approach lumbar fusion or surgery on the neck or cervical spine. Despite this lack of approval, Medtronic paid out over 60 million dollars to promote these “not approved” methods. Fifteen doctors were paid quite handsomely to endorse the use of Infuse.
This physician endorsement and subsequent multi-million dollar promotion helped increase the total sales for the Infuse bone graft system to somewhere in the vicinity of $800 million. Take note that 82.5% of these sales were for off-label use (the not FDA approved kind).
With the increase in off-label sales and uses, therein came the increased reports of problems, side effects, life threatening problems, and thus subsequent lawsuits. Between 2004 and July 2008, complications from off-label use began to roll in.
• Nerve injury
• Uninhibited bone growth
• Sexual side effects
• Neck and throat swelling
There were 280 reports of side effects due to the Infuse system and 38 reports that were life threatening. Three-fourths of these side effects were associated with the off-label uses. Is anyone seeing a problem here?
Well, in July 2008, the FDA must have thought so. They issue a warning regarding off-label Infuse bone graft use. Citing nearly 200 adverse reports of serious complications related to off-label Infuse bone graft use on the cervical spine, they warned of risks.
In November of this same year, the Department of Justice (DOJ) got involved and began investigating Medtronic for illegal advertisements of the Infuse graft. Also, in November 2008, Medtronic paid out 40 million dollars in whistleblower lawsuits related to Infuse.
July 2011 found life not improving for Medtronic when The Spine Journal published negative findings on Medtronic’s integrity. They reported that Medtronic had paid researchers to not report negative findings including bones dissolution, cancer, sterility in men, increased pain in back and legs, and infections. They ignored the fact that in 13 clinical trials paid for by Medtronic across a 10 year time span from 2000 to 2010, these complications occurred in anywhere from 10 – 50% of patients.
The story ends at this point in May of 2012 when the DOJ closed their investigation into the Medtronic practices. Alleging Medtronic paid physicians to publish good Infuse studies, the investigation also claimed failing to reveal that 85% of Infuse sales were dependent on off-label use.