Neurotoxin Consent Form 

This is an informed consent document which has been prepared to help your provider inform you about neurotoxin injections and its risks.
It is important that you read this information carefully and completely. Please initial each page, indicating that you have read the page, and sign the consent for this procedure as proposed by your provider and agreed upon by you.

GENERAL INFORMATION
Clostridia botulina bacteria produce a class of chemical compounds known as “toxins”. The Neurotoxins are processed and purified to produce a sterile product suitable for specific therapeutic uses. Once the diluted toxin is injected, it produces a temporary paralysis (chemodenervation) of muscle by preventing transmission of nerve impulses to muscle. The duration of muscle paralysis generally lasts for approximately three to four months.
Continuing treatments are necessary in order to maintain the effect of neurotoxins over time.
Neurotoxins have been approved to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), cervical dystonia (spastic muscle disorder with the neck) and motor disorders of the facial nerve (VII cranial nerve). As of April 2002, it has been FDA approved for the cosmetic treatment of forehead wrinkles caused by specific muscle groups. Other areas of the face and body such as crows feet wrinkles and neck bands may be treated in an “off-label” fashion. 
Neurotoxins have also been used “off-label” to treat migraine headaches, colorectal disorders, excessive perspiration disorders of the armpit and hands, and musculoskeletal pain disorders. Neurotoxin injections are customized for every patient, depending on his or her particular needs. These can be performed in areas involving the eyelid region, forehead, and neck. Neurotoxins cannot stop the process of aging. It can, however, temporarily diminish the look of wrinkles caused by muscle groups. Neurotoxin injections may be performed as a single procedure or as an adjunct to a surgical procedure.

ALTERNATIVE TREATMENTS
Alternative forms of management include not treating the skin wrinkles by any means. Improvement of skin wrinkles may be accomplished by other treatments or alternative types of surgery such as a blepharoplasty, face or brow lift when indicated. Other forms of eyelid surgery may be needed should you have intrinsic disorders affecting the function of the eyelid such as drooping eyelids from muscle problems (eyelid ptosis) or looseness between the eyelid and eyeball (ectropion). Minor skin wrinkling may be improved through chemical skin peels, lasers, injection of filling material, or other skin treatments. Risks and potential complications are associated with alternative forms of medical or surgical treatment.

RISKS OF NEUROTOXINS
Every procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo a cosmetic procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your provider to make sure you understand risks, potential complications, limitations, and consequences of neurotoxin injections.
Risks include but are not limited to: Incomplete Block, Bleeding and Bruising, Damage to Deeper Structures, Corneal Exposure Problems, Dry Eye Problems, Migration of Neurotoxins, Drooping Eyelid (Ptosis), Double Vision, Eyelid Ectropion, Other Eye Disorders, Blindness, Asymmetry, Pain, Allergic Reaction, Antibodies to Neurotoxins, Infection, Skin Disorders, Neuromuscular Disorders, Migraine Headache Disorders, Unsatisfactory Result, Long Term Effects, Pregnancy and/ or nursing complications, Drug Interaction, and any other Unknown Risks.

DISCLAIMER
Informed consent documents are used to communicate information about the proposed surgical treatment of a disease or condition along with disclosure of risks and alternative forms of treatment(s). The informed consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances. However, informed consent documents should not be considered all-inclusive in defining other methods of care and risks encountered. Your plastic surgeon may provide you with additional or different information which is based on all of the facts pertaining to your particular case and the current state of medical knowledge.
Informed consent documents are not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all of the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve.

OFF-LABEL FDA USE
There are many devices, medications injectable fillers and botulinum toxins that are approved for specific use by the FDA, but this proposed use is “Off-Label”, which is not specifically approved by the FDA. It is important that you understand this proposed use is not experimental and your provider believes it to be safe and effective. Examples of commonly accepted “Off-Label” use of drugs or devices include the use of aspirin for prevention of heart disease, retinoids for skin care, and injection of botulinum toxin for wrinkles around the eyes. 
It is important that you read the above information carefully and have all of your questions answered before signing the consent on the next page.

I acknowledge that no guarantee has been given by anyone as to the results that may be obtained.
 I Agree

I consent to be photographed or televised before, during, and after the procedure(s) to be performed, including appropriate portions of my body, for medical, scientific or educational purposes, provided my identity is not revealed by the pictures.
 I Agree
 I do not Agree
IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:
a. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
b. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT
c. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED

I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE-LISTED ITEMS. I AM SATISFIED WITH THE EXPLANATION.

By checking this box, I agree to use electronic records and signatures and I acknowledge that I have read the related consumer disclosure.
 I am the parent/guardian of this patient