Concerns over Medtronic’s Infuse Bone Graft valid

Concern over Medtronic’s Infuse Bone Graft, and the various adverse reaction reports is on the rise.

The concerns also raise questions as to whether or not Medtronic’s relationship with doctors which are paid by the company to promote the product via lectures could be interpreted as off-label promotion which is illegal.

While it is true that a doctor has complete authority to prescribe drugs, and medical devices for off-label use (uses for which they were not originally intended, or approved), the manufacturer itself is bound by the uses for which the product was FDA approved.

The concern is that drug companies and medical device manufacturers seem to have found a way around this restriction. The Medtronic allegation is but the latest example.

Concern first surfaced in July when the FDA warned that Infuse had been used off-label for cervical spine surgeries, which treat injuries to the neck. Approximately 38 reports referenced unwanted bone growth that fostered swelling of the neck which in turn compressed the airway and caused patients to have difficulty breathing, swallowing, even speaking.

Unfortunatley it appears that the off-label use of the Medtronic Infuse Bone Graft doesn’t stop there. In a recent expose by the Wall Street Journal, it was reported that potentially many more patients have been compromised by the off-label use of the Bone Graft, generating even more reports of bone growing where it shouldn’t be, within close proximity to nerves or outside the targeted fusion areas. The results can be traumatizing, often resulting in severe pain and repeat surgeries and, in some cases, emergency medical intervention.

And while the FDA reported 38 adverse reactions in July, the Wall Street Journal cited about 200–with roughly 75 percent of those attributed to off-label use.