This informed consent document has been prepared to help your injector inform you
about neurotoxin injections and their risks. It is important that you read this information
carefully and thoroughly. Please initial each page, indicating that you have read the
page, and sign the consent for this procedure as proposed by your injector.
General Information
Clostridium botulinum bacteria produce a class of chemical compounds known as
“toxins.” The Neurotoxins are processed and purified to yield a sterile product suitable
for specific therapeutic uses. Once the diluted toxin is injected, it produces a temporary
paralysis of muscle by preventing the transmission of nerve impulses to the muscle. The
duration of muscle paralysis generally lasts three to four months. Continuing treatments
are necessary to maintain neurotoxins’ effect 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 adjunct to a surgical procedure.
NEUROTOXIN INFORMED CONSENT
This informed consent document has been prepared to help your injector inform you
about neurotoxin injections and their risks. It is important that you read this information
carefully and thoroughly. Please initial each page, indicating that you have read the
page, and sign the consent for this procedure as proposed by your injector.
GENERAL INFORMATION
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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 medical or
surgical treatment forms.
RISKS OF NEUROTOXINS
Every procedure involves a certain amount of risk, and you must understand these risks
and the possible complications. In addition, every procedure has limitations. An
individual’s choice to undergo this procedure depends on comparing the risk to the
potential benefit. Although most patients do not experience these complications, you
should discuss each with your injector to ensure you understand the risks, possible
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 injector may provide you
with additional or different information 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 and injectable fillers and botulinum toxins that are
approved for specific use by the FDA, but this proposed use is “Off-Label”, that is not
specifically approved by the FDA. It is important that you understand this proposed use
is not experimental and your physician believes it to be safe and effective. Examples of
commonly accepted “Off-Label” use of drugs or devices include the use of aspirin for
the prevention of heart disease, retinoids for skin care, and injection of botulinum toxin
for wrinkles around the eyes. Botox® is approved for Glabellar frown lines,
Blepharospasm, and would be Off-Label for all other uses.
I acknowledge that I have been informed about the Off-Label FDA status of
Botox®, and I understand it is not experimental and accept its use.
ADDITIONAL TREATMENT NECESSARY
There are many variable conditions in addition to risk and potential complications that
may influence the long- term result of BOTOX injections. Even though risks and
complications occur infrequently, the risks cited are the ones that are particularly
associated with BOTOX injections. Other complications and risks can occur but are
even more uncommon. Should complications occur, additional surgery or other
treatments may be necessary. The practice of medicine and surgery is not an exact
science. Although good results are expected, there is no guarantee or warranty expressed
or implied, on the results that may be obtained.
It is important that you read the above information carefully and have all of your
questions answered before the consent on the next page.
INFORMED CONSENT FOR NEUROTOXIN INJECTIONS
THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF
TREATMENT
THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED
I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVELISTED
ITEMS. I AM SATISFIED WITH THE EXPLANATION.
IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:
- I hereby authorize and such assistants as may be selected to
- perform the following procedure or treatment: BOTOX, JEAUVEAU OR XEOMIN
- INJECTION
- I recognize that during the course of the procedure, unforeseen conditions may
- necessitate different procedures than those above.
- I acknowledge that no guarantee has been given by anyone as to the results that may
- be obtained.
- I consent to be photographed or televised before, during, and after the procedure to
- be performed, including appropriate portions of my body, for medical, scientific or
- educational purposes.
- For purposes of advancing medical education, I consent to the admittance of
observers to the treatment room.
IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:
- THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
- THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF
- TREATMENT
- THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED
- I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVELISTED
- ITEMS. I AM SATISFIED WITH THE EXPLANATION.
