Since the introduction of the product, significant health issues have developed in Infuse patients. While the product was intended to promote bone growth, it has become clear that it does its job too well. As a result, Infuse patients have experienced excessive bone growth, which leads to serious complications. This excess bone growth is known to create pressure on the spinal cord and the nerves surrounding it, which leads to significant reactions including:
Perhaps the area most adversely affected by the Infuse product is the neck, known in medical circles as the cervical spine. As noted in the section concerning the history of the Infuse product, Infuse was only FDA approved for use in one level of the lower (lumbar) spine. At no time has the FDA or any other governmental agency in the United States given approval for the use of the product in the cervical region.
Despite this fact, many patients have had the Infuse product placed in their neck, some at more than one level. Allegations against Medtronic suggest that contrary to FDA rules, they have actively promoted this off-label use of the product. Sadly, many patients were unaware that the use of the product in the cervical region was not FDA approved nor were they advised of the potential side effects.
Predictably, many cervical Infuse patients now suffer from substantial complications, including swelling in the neck and pressure on their throats which adversely affects their ability to swallow food, and even breath. It appears that bone overgrowth has led to a constriction of the throat and airways.
Complications due to lumbar (lower spine) fusion can be just as devastating to a patients health. Burning sensations and pain radiation down one or both legs are common side effects. It would appear that lumbar complications are generally due to excessive bone growth as a result of the usage of too much BMP, however some of the complications can be traced to off-label techniques used to implant the Infuse Product in the body.