INSTRUCTIONS
This is an informed-consent document that has been prepared to help inform you about Botulina Toxin A
(BTA)-BOTOX®, Dysport, and Xeomin- injections, its risks, as well as alternative treatment(s).
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 treatment as proposed by a Silk, A Medical Spa
professional +10.
and agreed upon by you

GENERAL INFORMATION
Clostridia botulina bacteria produce a class of chemical compounds known as “toxins”. The Botulina Toxin
A is processed and purified to produce a sterile product suitable for specific therapeutic uses. Once the
diluted toxin is injected, it produces a temporary weakness (chemo denervation) of muscle by preventing
transmission of nerve impulses to muscle. The duration of muscle weakness lasts approximately three to
four months.
BOTOX has 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 as of April 2002, it has been FDA-approved for the cosmetic treatment of wrinkles between the brows
caused by specific muscle groups. Other areas of the face and body such as crow’s feet wrinkles and neck
bands may be treated in an “off-label” fashion. BOTOX has also been used to treat migraine headaches,
colorectal disorders, excessive perspiration disorders of the armpit and hands, and musculoskeletal pain
disorders.
BTA 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. BTA cannot stop the process of aging.
It can however, temporarily diminish the look of wrinkles caused by muscle groups. BTA injections may be
performed as a singular procedure or as an adjunct to a surgical procedure.

AALTERNATIVE 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 fillers or fat, or other skin treatments. Risks and potential
complications are associated with alternative forms of medical or surgical treatment.

INHERENT RISKS OF BTA INJECTIONS
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 surgical 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 plastic surgeon to make sure you understand risks, potential complications, limitations,
and consequences of BTA injections. Additional information concerning BTA may be obtained from the
package-insert sheets supplied by Allergan.

SPECIFIC RISKS OF BOTOX (BOTULINA TYPE A TOXIN) INJECTIONS
Incomplete Result:
It is possible to not experience a complete result of targeted muscles. Additional injections to reach the
desired level of result can be performed until the goal is achieved.
Asymmetry:
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 BTA injection.

Drooping Eyelid (Ptosis):
Muscles that raise the eyelid may be affected by BTA, should this material migrate downward from other
injection areas. Should this problem occur, it is temporary and additional treatments such as eye drops may
be necessary.

Pain:
Discomfort associated with BTA injections is usually of short duration.
Migration of BTA:
BTA may migrate from its original injection site to other areas and produce temporary weakness of other
muscle groups or other unintended effects. BTA has been reported to cause swallowing problems in
patients treated for spastic muscle disorders of the neck region (cervical dystonia).
Bleeding and Bruising:
It is possible, though unusual, to have a bleeding episode from a BTA injection. Bruising in soft tissues
may occur. Serious bleeding around the eyeball during deeper BTA injections for crossed eyes
(strabismus) has occurred. Should you develop post-injection bleeding, you may require emergency
treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E,
ginkgo biloba, and other “herbs / homeopathic remedies” may contribute to a greater risk of a bleeding
problem. Do not take these for ten days before BTA injections. If you are taking these medications, please
inform your surgeon prior to proceeding.
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.
Corneal Exposure Problems:
Some patients experience difficulties closing their eyelids after BTA 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.

Unknown Risks:
The long-term effect of BTA on tissue is unknown. The risk and consequences of accidental intravascular
injection of BTA is unknown and not predictable. There is the possibility that additional risk factors may be
discovered.
Dry Eye Problems:
Individuals who normally have dry eyes may be advised to use special caution in considering BOTOX
injections around the eyelid region.
Double-Vision:
Double-vision may be produced if the BTA material migrates into the region of muscles that control
movements of the eyeball.
Eyelid Ectropion:
Abnormal looseness of the lower eyelid can occur following BTA injection.
Other Eye Disorders:
Functional and irritive disorders of eye structures may rarely occur following BTA injections.
Blindness:
Blindness is extremely rare after BTA injections. However, it can be caused by internal bleeding around
the eyeball or needle stick injury. In a period of 10 years of BOTOX administration, complications of blurred
vision, retinal vein occlusion, and glaucoma have been reported in three patients. The occurrence of eye
problems appears to be very rare.
Allergic Reactions:
As with all biologic products, allergic and systemic anaphylactic reactions may occur. Allergic reactions
may require additional treatment.
Antibodies to BTA:
Presence of antibodies to BOTOX may reduce the effectiveness of this material in subsequent injections.
The health significance of antibodies to BTA is unknown.

Infection:
Infection is extremely rare after BTA injection. Should an infection occur, additional treatment including
antibiotics may be necessary.
Skin Disorders:
Skin rash, itching, and swelling may rarely occur following BTA injection.
Neuromuscular Disorders:
Patients with peripheral motor neuropathic disorders (amyotrophic lateral sclerosis, myasthenia gravis, and
motor neuropathies) may be at greater risk of clinically significant side effects from BTA.
Migraine Headache Disorders:
BOTOX has been used to treat forehead muscle groups that are involved with the migraine headache
condition. Patients are advised that results of BTA treatment for migraine headaches may be variable and
improvement in this disorder may not occur following BTA treatments.
Unsatisfactory Result:
There is the possibility of a poor or inadequate response from BTA injection. Additional BTA injections may
be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those
caused by muscle activity. Unsatisfactory results may NOT improve with each additional treatment.

Long-Term Effects:
Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss, weight
gain, sun exposure, pregnancy, menopause, or other circumstances not related to BTA injections. BTA
injection does not stop the aging process or produce permanent tightening of skin. Future surgery or other
treatments may be necessary.
Pregnancy and Nursing Mothers:
Animal reproduction studies have not been performed to determine if BTA could produce fetal harm. It is
not known if BTA can be excreted in human milk. It is not recommended that pregnant women or nursing
mothers receive BTA treatments. Please inform your surgeon prior to proceeding if you are pregnant or
think you could be or if you are nursing.
Drug Interactions:
The effect of BTA may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with
neuromuscular transmission.
DISCLAIMER
Informed-consent documents are used to communicate information about the proposed procedure along
with disclosure of risks and alternative forms of treatment(s), including a decision not to proceed with the
procedure. This document is based on a thorough evaluation of scientific literature and relevant clinical
practices to describe a range of generally acceptable risks and alternative forms of management of a
particular disease or condition. 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 medical spa professional may provide you with additional or different
information which is based on all the facts in 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.
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.