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INFORMED-CONSENT-BOTOX
INJECTION |
| INSTRUCTIONS |
This is an informed-consent document which has been prepared
to help your plastic surgeon 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 initial each page, indicating that you
have read the page and sign the consent for this procedure
as proposed by your plastic surgeon.
INTRODUCTION
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 lasts for approximately three months.
BOTOX has been used to treat certain conditions involving
crossed eyes (strabismus), eyelid spasm (blepharospasm), and
motor disorders of the facial nerve (VII cranial nerve). It
has been used in other "off-label" uses for the treatment of
facial wrinkles and neck bands caused by specific muscle
groups. 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 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 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.
Bleeding- 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.
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-Double-vision may be produced if the BOTOX
material migrates into the region of muscles that control
movements of the eyeball.
Eyelid Ectropion- 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.
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 BOTOX injection.
Pain- Discomfort associated with BOTOX injections is usually
short duration.
Skin disorders- Skin rash and swelling may rarely occur
following BOTOX injection.
Unknown risks-The long term effect of BOTOX on tissue is
unknown. There is the possibility of additional risk factors
may be discovered.
Unsatisfactory result-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.
Allergic reactions-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- Infection is extremely rare after BOTOX
injection. Should an infection occur, additional treatment
including antibiotics may be necessary.
Long-term effects- Subsequent alterations in face and eyelid
appearance may occur as the result of aging, weight loss of
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- 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.
Drug Interactions- The effect of BOTOX may be potentiated by
aminoglycoside antibiotics or other drugs known to interfere
with neuromuscular transmission.
HEALTH INSURANCE
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.
FINANCIAL RESPONSIBILITIES
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.
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 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.
GoSculptura reminds you that all cosmetic surgery carries a
risk, has limitations which could include disappointment
with the results.
You should agree about the anticipated outcome of your
surgery and concur about your expectations of the results.
You should discuss alternative treatments and thoroughly
understand the risk of the procedures
If any dispute may arise the surgeon is only liable if
litigation takes place in Argentina, under Argentinean Law.
It is important that you read the above information
carefully and have all of your questions answered before
signing the consent.
CONSENT FOR SURGERY/ PROCEDURE or TREATMENT
1. I hereby authorize Dr.__________________ and such
assistants as have been selected to perform the following
procedure or treatment:
_____________________________________________________________
I have received the following information sheet:
INFORMED-CONSENT for BOTOX Injection
_____________________________________________________________
2. 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 assistants or
designees 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.
3. 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.
4. I acknowledge that no guarantee has been given by anyone
including GoSculptura or any of the staff employed by
GoSculptura as to the results that may be obtained. If any
litigation may arise as result of the surgery it can only be
done in Argentina under Argentinean Law and that
GoSculptura, its management or staff can not be held liable
in any way what so ever.
5. 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 (1-5). I AM SATISFIED WITH THE EXPLANATION.
______________________________________________________________
Patient or Person Authorized to Sign for Patient |
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GoSculptura offers packages offering plastic surgery in Argentina as well as plastic surgery in Tunisia competitively priced with leading board certified plastic surgeons in leading plastic surgery clinics in Argentina as well as plastic surgery clinics in Tunisia.
We also offer gastric bypass surgeries, in-vitro fertilization surgeries, and cosmetic dentistry.
Terms And Conditions | Informed Consent
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