This is an informed consent document
which has been prepared to help inform you about laser
resurfacing procedures of skin, 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 surgery as
proposed by your plastic surgeon.
INTRODUCTION
Lasers have been used by plastic surgeons as a surgical
instrument for many years. Laser energy can be used to cut,
vaporize, or selectively remove skin and deeper tissues.
There are many different methods for the surgical use of
lasers.
Conditions such as wrinkles, sun damaged skin, scars and
some types of skin lesions/disorders may be treated with the
CO2 and Erbium laser. Certain surgical procedures may use
the CO2 laser as a cutting instrument. In some situations,
laser treatments may be performed at the time of other
surgical procedures.
Skin treatment programs may be used both before and after
CO2 laser skin treatments in order to enhance the results.
ALTERNATIVE TREATMENT
Alternative forms of treatment include not undergoing the
proposed laser skin resurfacing procedure. Other forms of
skin treatment (chemical peel) or surgical procedures
(dermabrasion or excisional surgery) may be substituted. In
certain situations, the laser may offer a specific
therapeutic advantage over other forms of treatment.
Alternatively, laser resurfacing procedures in some
situations may not represent a better alternative to other
forms of surgery or skin treatment when indicated. Risks and
potential complications are associated with alternative
forms of treatment that involve skin resurfacing(s) or
surgical procedures.
RISKS OF LASER RESURFACING PROCEDURES OF SKIN
There are both risks and complications associated with all
laser treatment procedures of the skin. Risks involve both
items that specifically relate to the use of laser energy as
a form of surgical therapy and to the specific procedure
performed. An individual’s choice to undergo a procedure is
based on the comparison of 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 the risks,
potential complications, and consequences of laser skin
treatment.
Infection- Although infection following laser skin treatment
is unusual, bacterial, fungal, and viral infections can
occur. Herpes simplex virus infections around the mouth, can
occur following a laser treatment. This applies to both
individuals with a past history of Herpes simplex virus
infections and individuals with no known history of Herpes
simplex virus infections in the mouth area. Specific
medications must be prescribed and taken both prior to and
following the laser treatment procedure in order to suppress
an infection from this virus. Should any type of skin
infection occur, additional treatment including antibiotics
may be necessary.
Scarring- Although normal healing after the procedure is
expected, abnormal scars may occur both in the skin and
deeper tissues. In rare cases, keloid scars may result.
Scars may be unattractive and of different color than the
surrounding skin. Additional treatments may be needed to
treat scarring.
Burns- Laser energy can produce burns. Adjacent structures
including the eyes may be injured or permanently damaged by
the laser beam. Burns are rare, yet represent the effect of
heat produced within the tissues by laser energy. Additional
treatment may be necessary to treat laser burns.
Color change- Laser resurfacing may potentially change the
natural color of your skin. Skin redness usually lasts 1-3
months and occasionally 6 months following laser skin
resurfacing. There is the possibility of irregular color
variations within the skin including areas that are both
lighter and darker. A line of demarcation between normal
skin and skin treated with lasers can occur.
Accutane (isotretinoin)- Accutane is a prescription
medication used to treat certain skin diseases. This drug
may impair the ability of skin to heal following treatments
or surgery for a variable amount of time even after the
patient has ceased taking it. Individuals who have taken
this drug are advised to allow their skin adequate time to
recover from Accutane before undergoing laser skin treatment
procedures.
Fire-Inflammable agents, surgical drapes and tubing, hair,
and clothing may be ignited by laser energy. Laser energy
used in the presence of supplemental oxygen increases the
potential hazard of fire. Some anesthetic gases may support
combustion.
Laser smoke (plume)- Laser smoke is noxious to those who
come in contact with it. This smoke may represent a possible
bio-hazard.
Bleeding- Bleeding is rare following laser skin resurfacing
procedures. Should bleeding occur, additional treatment may
be necessary.
Skin tissue pathology-Laser energy directed at skin lesions
may potentially vaporize the lesion. Laboratory examination
of the tissue specimen may not be possible.
Visible skin patterns- Laser treatment procedures may
produce visible patterns within the skin. The occurrence of
this is not predictable.
Patient failure to follow through-Patient follow through
following a laser skin resurfacing procedure is important.
Post operative instructions concerning appropriate
restriction of activity, use of dressings, and use of sun
protection need to be followed in order to avoid potential
complications, increased pain, and unsatisfactory result.
Your physician may recommend that you utilize a long-term
skin care program to enhance healing following a laser skin
resurfacing.
Distortion of anatomic features-Laser skin treatments can
produce distortion of the appearance of the eyelids, mouth,
and other visible anatomic landmarks. The occurrence of this
is not predictable. Should this occur, additional treatment
including surgery may be necessary.
Damaged skin- Skin that has been previously treated with
chemical peels or dermabrasion, or damaged by burns,
electrolysis (hair removal treatments), or radiation therapy
may heal abnormally or slowly following treatment by lasers
or other surgical techniques. The occurrence of this is not
predictable. Additional treatment may be necessary.
Unsatisfactory result- There is the possibility of an
unsatisfactory result from these procedures. Laser
resurfacing procedures may result in unacceptable visible
deformities, skin slough, loss of function, and permanent
color changes in the skin. You may be disappointed with the
final result from laser resurfacing.
Skin cancer/skin disorders- Laser skin resurfacing
procedures may not offer protection against developing skin
cancer or skin disorders in the future.
Pain- Very infrequently, chronic pain may occur after laser
skin resurfacing procedures.
Allergic reactions- In rare cases, local allergies to tape,
preservatives used in cosmetics or topical preparations have
been reported. Systemic reactions which are more serious may
result from drugs used during surgery and prescription
medicines. Allergic reactions may require additional
treatment.
Lack of permanent results- Laser or other resurfacing
treatments may not completely improve or prevent future skin
disorders, lesions, or wrinkles. No technique can reverse
the signs of skin aging. Additional surgical procedures may
be necessary to further tighten loose skin.
Delayed healing-It may take longer than anticipated for
healing to occur after laser treatments. Skin healing may
result in thin, easily injured skin. This is different from
the normal redness in skin after a laser treatment.
Unknown risks- There is the possibility that additional risk
factors of laser skin resurfacing may be discovered. The
results of performing skin tightening surgery and laser
resurfacing is unknown in terms of the combination effect of
the two procedures and potential complications, depending on
the area treated. Skin slough, delayed healing and poor
surgical outcome may occur.
Surgical anesthesia- Both local and general anesthesia
involve risk. There is the possibility of complications,
injury, and even death from all forms of surgical anesthesia
and sedation.
ADDITIONAL TREATMENT OR SURGERY NECESSARY
There are many variable conditions which influence the long
term result of CO2 laser skin treatments. Even though risks
and complications occur infrequently, the risks cited are
the ones that are particularly associated with these
procedures. 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 laser skin resurfacing involves several charges
for the services provided. This includes fees charged by
your doctor, the cost of pre and post-operative skin care
medications, surgical supplies, laser equipment and
personnel, laboratory tests, and possible outpatient
hospital charges, depending on where the procedure is
performed. It is unlikely that cosmetic surgery costs would
be covered by an insurance plan. Even if there is some
insurance coverage, you will be responsible for necessary
co-payments, deductibles, and charges not covered.
Additional costs may occur should complications develop from
the surgery. Secondary surgery or hospital day-surgery
charges involved with revisionary surgery or treatments
would also be your responsibility.
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
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.
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 may be selected to perform the following
procedure or treatment:
__________________________________________________
I have received the following information sheet:
INFORMED CONSENT FOR LASER RESURFACING OF THE SKIN
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 involves 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. I consent to the disposal of any tissue, medical devices
or body parts which may be removed.
6. 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 (1-6). I AM SATISFIED WITH THE EXPLANATION.
______________________________________________________
Patient or Person Authorized to Sign for Patient
Date____________________ Witness________________________
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