Consent For Spinal Surgery (Page 3 of 4) in pdf

fixation device, bio-implant or fusion enhancer is appropriate.

These devices, or

substances, may consist of screws, hooks, connecting rods, plates, wires, various

polymers, cement, bio-implants (absorbable or non-absorbable) or various bone graft

alternatives, enhancers or extenders. These devices may be anchored by screws or

other attachments inserted into the bony pedicles, intervertebral bodies, the cranium or

the lateral masses of the vertebral bodies.

Rods, plates, or wires may then be

connected to these implanted screws or anchors, thus constructing a rigid framework to

hold the bones immobile until the fusion heals. It is my doctor’s conviction that the use

of these fixation devices will significantly increase the probability that my fusion will heal.

My doctor has completed a fellowship in spinal surgery.

His elected practice is

primarily the evaluation and treatment of spinal disorders. By virtue of his special

training and extensive practice experience, he has developed the knowledge and ability

to safely use these internal fixation devices and bio-substances. Any fixation device

may fail or break. If my fusion does not heal, the graft, screws, wires, rods, cages,

intervertebral devices or plates may break or disengage and there may be loss of spinal

correction. This rarely may cause injury to the surrounding soft tissue structures. When

my doctor implants these devices, there exists the possibility of injury to the bones,

nerves or adjacent tissues such as blood vessels, tendons or ligaments. There also is

the possibility that these devices may need to be removed at a later date. Alternatives

to use of these fixation devices include the use of no internal fixation at all or the use of

a brace or cast. I do not wish to engage in these alternatives.

14. ___

The Food and Drug Administration has not approved screws for use in certain pedicles

of the spine or in several spinal disorders. The use of methyl methacrylate or bone

cement is also not approved by the FDA for use in the spine. These devices and

substances are considered investigational by the FDA. Pedicle screws are approved for

use in the sacrum and various lumbar disorders. It is quite common and legally and

medically appropriate to use FDA approved devices, substances or medications for

uses other than those for which they are specifically approved. My doctor believes that

use of a pedicle fixation device, occipital screw attachment, lateral mass screw, or other

devices or substances within my spine will significantly improve the chances that my

fusion will heal or my condition will approve. In spite of the risks inherent in their use

and in spite of the investigational nature of these devices, I am aware that my physician

strongly believes that he can safely use them to increase the probability that my fusion

will heal.

15. ___

Pre-operative and post operative bracing may be prescribed for any spinal disorder. I

have been instructed on the use of this immobilization device, when I must wear it, and

various activities that are contraindicated during the bracing period. I consent to such

bracing.

16. ___

Donor site complications may result from harvesting my bone should it be necessary

which include numbness and tingling, pain, nerve damage, infection, damage to the

vessels and muscles and pelvic or bony instability due to bone loss.

17. ___

Drs. Byers and Su, due to their experience and expertise in spinal research may ask me

to participate in research protocols sponsored by various spinal research societies,

industry or of his own design. If I decide to participate in such research, I understand I

will be asked to read and sign a separate consent form that has been approved by the

Marin General Hospital Institutional Review Board, a committee that approves and

monitors research in which humans are involved.

Consent For Spinal Surgery Page 3

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