The informed consent may include a discussion of any aspects of the proposed procedure that is experimental or not fully cleared by the FDA. This should also be clearly expressed in the consent form. The consent form will include discussion that elaborates on potential complications and emergencies associated with the procedure. The consent form will need to be signed and dated by the patient as well as the attending surgeon.

Learn the Risks, Review the Options, and Confirm the Indications:

The decision to undergo any procedure is based on fact that the benefit substantially outweighs the risk. Some risk factors are considered general to surgery whereas others are very specific to the procedure. Examples of general surgical risks include adverse reaction to anesthesia, excessive bleeding, the development of scar tissue, infection, stroke, and the chance of death. Your attending spine surgeon may be aware of unique risks associated with the technique that he or she has chosen to use. Risks specifically associated with procedures include pedicle screw failure, fusion failure, kyphoplasty failure, etc. The surgeon should be able to provide an answer for the likelihood of each risk based on a review of the literature and his or her personal experience.

The discussion of reasonable alternative options should not be limited to any specific healthcare discipline, but should include those approaches that have been shown to have positive outcome.