INFORMED CONSENT NEUROMODULATOR
(Botulina Toxin Type A, As Botox Cosmetic, Dysport or Xeomin)
Please review the following consent form prior to your visit. You will have the opportunity to ask your provider any questions you may have regarding this consent and will then be asked to sign a copy in our office.
This is an informed consent document which has been prepared to help your plastic surgeon/injector inform you concerning BOTOX (Botulina Toxin Type A) injection, its risks, and alternative treatments. It is important that you read this information carefully and completely. Please read each page and sign the consent for treatment as proposed by your Clinician.
Clostridia botulina bacteria produce a class of chemical compounds known as "toxins". The Botulina Type A Toxin (BOTOX) is 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
last for approximately three months. BOTOX has been used to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), motor disorders of the facial nerve (VII cranial nerve), and migraines. It has been used in other "off-label" uses for the treatment of facial wrinkles and neck bands caused by specific muscle groups. In 2004, BOTOX was approved by the FDA for cosmetic uses in the face and neck. Certain spastic muscle disorders with the neck and colorectal area have also been treated with this agent.
BOTOX 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. BOTOX cannot stop the process of aging. It can however, temporarily diminish the look of wrinkles caused by muscle groups. BOTOX injections may be performed as a singular procedure or as an adjunct to a surgical procedure.
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 browlift 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 BOTOX (Botulina Type A Toxin) INJECTIONS:
Every procedure involves a certain amount of risk, and it is important that you understand the risks involved. An individual's choice to undergo this procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience the following complications, you should discuss each of them with your plastic surgeon to make sure you understand the risks, potential complications, and consequences of BOTOX injections.
It is possible, though unusual, to have a bleeding episode from a BOTOX injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball during deeper BOTOX injections for crossed eyes (strabismus) has occurred. Should you develop post-injection bleeding, it may require emergency treatment or surgery. Do not take any aspirin or anti-inflammatory medications for seven days before BOTOX injections, as this may contribute to a greater risk of a bleeding problem.
DAMAGE TO DEEPER STRUCTURES:
Deeper structures such as nerves, blood vessels, and the eyeball may be damaged during the course of injection. Injury to deeper structures may be temporary or permanent.
RISKS OF NEUROTOXIN INJECTIONS
CORNEAL EXPOSURE PROBLEMS:
Some patients experience difficulties closing their eyelids after BOTOX injections and problems may occur in the cornea due to dryness. Should this rare complication occur, additional treatments, protective eye drops, contact lenses, or surgery may be necessary.
DRY EYE PROBLEMS:
Individuals who normally have dry eyes may be advised to use special caution in considering BOTOX injections around the eyelid region.
MIGRATION OF BOTOX:
BOTOX may migrate from its original injection site to other areas and produce temporary paralysis of other muscle groups or other unintended effects.
DROOPING EYELID (PTOSIS):
Muscles that raise the eyelid may be affected by BOTOX, should this material migrate downward from other injection areas.
Double vision may be produced if the BOTOX material migrates into the region of muscles that control movements of the eyeball.
Abnormal looseness of the lower eyelid can occur following BOTOX injection.
OTHER EYE DISORDERS:
Functional and irritative disorders of eye structures may rarely occur following BOTOX injections.
The human face and eyelid region is normally asymmetrical with respect to structural anatomy and function. There can be a variation from one side to the other in terms of the response to BOTOX injection.
Discomfort associated with BOTOX injections is usually short duration.
Skin rash and swelling may rarely occur following BOTOX injection.
The long-term effect of BOTOX on tissue is unknown. There is the possibility that additional risk factors may be discovered.
There is the possibility of a poor or inadequate response from BOTOX injection. Additional BOTOX injections may be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those caused by muscle activity.
As with all biologic products, allergic and systemic anaphylactic reactions may occur. Allergic reactions may require additional treatment.
ANTIBODIES TO BOTOX:
Presence of antibodies to BOTOX may reduce the effectiveness of this material in subsequent injections. The health significance of antibodies to BOTOX is unknown.
Infection is extremely rare after BOTOX injection. Should an infection should occur, additional treatment including antibiotics may be necessary.
Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss or gain, sun exposure, or other circumstances not related to BOTOX injections. BOTOX injection does not arrest the aging process or produce permanent tightening of the eyelid region. Future surgery or other treatments may be necessary.
PREGNANCY AND NURSING MOTHERS:
Animal reproduction studies have not been performed to determine if BOTOX could produce fetal harm. It is not known if BOTOX can be excreted in human milk.
Blindness is extremely rare after BOTOX injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. The occurrence of this is very rare.
The effect of BOTOX may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission.
Most health insurance companies exclude coverage for cosmetic surgical procedures and treatments or any complications that might occur from the same. Please carefully review your health insurance subscriber information pamphlet.
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.
The cost of BOTOX injection may involve several charges. This includes the professional fee for the injections, follow up visits to monitor the effectiveness of the treatment, and the cost of the BOTOX material itself. It is unlikely that BOTOX injections to treat cosmetic problems would be covered by your health insurance. Additional costs of medical treatment would be your responsibility should complications develop from BOTOX injections.
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 to 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 surgeon may provide you with additional or different information which is based on all the facts in your particular case and the 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. It is important that you read the above information carefully and have all of your questions answered before signing this informed consent.
CONSENT FOR TREATMENT:
I hereby authorize my Clinician to perform the following procedure or treatment:
BOTOX Injection, as either Botox, Botox Cosmetic, Dysport, or Xeomin.
I have reviewed the following information:
INFORMED CONSENT FOR BOTOX / DYSPORT INJECTION
I recognize that during the course of the operation and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than those above. I therefore authorize the above Physician and or Nurse Injector to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that require treatment and are not known to my physician at the time the procedure is begun.
I consent to the administration of such anesthetics considered necessary or advisable. I understand that all forms of anesthesia involve risk and the possibility of complications, injury, and sometimes death.
I acknowledge that no guarantee has been given by anyone as to the results that may be obtained.
I consent to the photographing or televising of the operation(s) or procedures(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.
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 UNDERTAKE
THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT
THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED