Clostridia botulina bacteria
produce a class of chemical compounds known as “toxins.” The Botulina Type A Toxin (BOTOX COSMETIC) 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 the muscle. The duration of muscle paralysis lasts for
approximately three months.
BOTOX COSMETIC has been used to treat
certain conditions involving crossed eyes (strabismus), eyelid spasm
(blepharospasm), motor disorders of the facial nerve (VII cranial nerve) as
well as facial wrinkles and increased sweating. Certain muscle spastic muscle disorders
with the neck and colorectal areas have also been treated with this agent.
BOTOX COSMETIC 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.
It may also be used for hyperhidrosis (excessive sweating) in areas
such as the axilla (arm-pits), palms, groin,
etc. It should be realized that BOTOX
cannot stop the process of aging. It
can, however, temporarily diminish the look of wrinkles caused by muscle
groups. BOTOX COSMETIC injections may be
performed as a singular procedure or as an adjunct to a surgical procedure.
BOTOX COSMETIC is intended to diminish
dynamic wrinkling; that is, wrinkles that are produced by facial
animation. BOTOX COSMETIC will not affect
static wrinkling nor will it affect fine lines. BOTOX COSMETIC usually takes 5-7 days
to reach its maximal effect.
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
Alternative methods of treating
hyperhidrosis include antiperspirants, surgical sympathectomy
or no treatment at all. Risks and potential complications are associated with
alternative forms of medical or surgical treatment.
RISKS OF BOTOX COSMETIC (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 risks 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
It is possible, though
unusual, to have a bleeding episode from a BOTOX COSMETIC injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball during
deeper BOTOX COSMETIC injections for crossed eyes (strabismus) has occurred. Should you develop post-injection bleeding,
it may require emergency treatment or surgery. Do not take aspirin or anti-inflammatory
medications for seven days before BOTOX COSMETIC injections, as this may contribute to
a greater risk of a bleeding problem.
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.
Some patients experience
difficulties closing their eyelids after BOTOX COSMETIC 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 might be necessary.
Individuals who normally
have dry eyes are advised to use special caution in considering BOTOX COSMETIC
injections around the eyelid region.
Your specific concerns should be address with your plastic surgeon.
MIGRATION OF BOTOX COSMETIC
BOTOX COSMETIC may migrate form its original injection site to other areas
and produce temporary paralysis of other muscle groups or other unintended
raise the eyelid may be affected by BOTOX COSMETIC, should this material
migrate downward from other injection areas.
Double vision may occur if
the BOTOX COSMETIC material migrates into the region of muscles that
control movements of the eyeball.
looseness of the lower eyelid can occur following BOTOX COSMETIC injection
Functional and irritative disorders of eye structures may rarely occur
following BOTOX COSMETIC 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 COSMETIC injection.
associated with BOTOX COSMETIC injections is usually short in duration.
Skin rash and
swelling may rarely occur following BOTOX COSMETIC injections.
The long term
effect of BOTOX COSMETIC 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 a BOTOX COSMETIC injection. Additional BOTOX COSMETIC injections may be
necessary. There will be a charge for
any additional BOTOX COSMETIC injection.
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
Presence of antibodies to
BOTOX COSMETIC may reduce the effectiveness of this material in subsequent
injections. The health significance of
antibodies to BOTOX COSMETIC is unknown.
Infection is extremely
rare after a BOTOX COSMETIC injection. Should
an infection occur, additional treatment, including antibiotics, might be
Subsequent alterations in
face and eyelid appearance may occur as a result of aging, weight loss or
gain, sun exposure or other circumstances not related to BOTOX COSMETIC
injections. BOTOX COSMETIC injections do 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
studies have not been performed to determine if BOTOX COSMETIC could produce fetal
harm. It is not known if BOTOX COSMETIC can be
excreted in human milk.
Blindness is extremely rare
after BOTOX COSMETIC injections. However, it
can be caused by internal bleeding around the eyeball or needle stick injury.
The effect of BOTOX COSMETIC may be potentiated by aminoglycoside
antibiotics or other drugs known to interfere with neuromuscular
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
ADDITIONAL TREATMENT NECESSARY
There are many variable conditions
in addition to risk and potential complications that may influence the
long-term result of BOTOX COSMETIC injections.
Even though risks and complications
occur infrequently, the risks cited are the ones that are particularly
associated with BOTOX COSMETIC 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 warrantee, expressed or
implied, on the results that may be obtained.
The cost of
BOTOX COSMETIC 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 COSMETIC material
itself. Should you require a touch-up,
an additional fee will be charged. It
is unlikely that BOTOX COSMETIC injections to treat cosmetic problems would be covered
by your health insurance. Additional
costs off medical treatment would be your responsibility should complications
develop from BOTOX COSMETIC injections.
Should the patient not attain the
maximal effect, please call the office within two weeks from your last BOTOX
injection. You MUST be seen by your
physician within that period. At the
discretion of your physician, a touch-up will be scheduled, at no additional
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 state of
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