INFORMED-CONSENT--
BREAST AUGMENTATION MAMMAPLASTY |
| INSTRUCTIONS |
This is an informed-consent document that has been prepared
to help inform you about augmentation mammaplasty, 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 surgery as
proposed by your plastic surgeon.
GENERAL INFORMATION
Augmentation mammaplasty is a surgical operation performed
to enlarge the breasts for a number of reasons:
To enhance the body contour of a woman, who for personal
reasons feels that her breast size is too small.
To correct a loss in breast volume after pregnancy.
To balance breast size, when there exists a significant
difference between the size of the breasts.
To restore breast shape after partial or total loss of the
breasts for various conditions.
To replace existing breast implants for cosmetic or
reconstructive reasons.
Breast implant surgery is contraindicated in women with
untreated breast cancer or pre-malignant breast disorders,
active infection anywhere in the body, or individuals who
are currently pregnant or nursing. Individuals with a
weakened immune system (currently receiving chemotherapy or
drugs to suppress the immune system), conditions that
interfere with blood clotting or wound healing, or have
reduced blood supply to the breast tissue from prior surgery
or radiation therapy treatments may be at greater risk for
complications and poor surgical outcome. According to the
USFDA, a woman must be at least 18 years of age for cosmetic
breast augmentation.
Breast enlargement is accomplished by inserting a breast
implant either behind the breast tissue or under the chest
muscles. Incisions are made to keep scars as inconspicuous
as possible, usually under the breast, around the lower part
of the areola, or in the armpit. Breast implants are
manufactured in a variety of shapes, sizes, and with either
smooth or textured surfaces. The method of implant selection
and size, along with surgical approach for inserting and
positioning breast implants will depend on your preferences,
your anatomy and Su cirujana’s recommendation. The shape
and size of the breasts prior to surgery will influence both
the recommended treatment and the final results. If the
breasts are not the same size or shape before surgery, it is
unlikely that they will be completely symmetrical afterward.
Conditions which involve sagging of the breast or diminished
skin tone (stretch marks) may require additional surgical
Procedimiento (breast lift) to reposition the nipple and areola
upward and to remove loose skin.
Patients undergoing augmentation mammaplasty surgery must
consider the following:
ß Changes that occur to the breasts following augmentation
or reconstruction with implants are not reversible. There
may be an unacceptable appearance to the breast if you later
choose to have breast implants removed.
ALTERNATIVE TREATMENT
Augmentation mammaplasty is an elective surgical operation.
Alternative treatment would consist of the use of external
breast prostheses or padding, or the transfer of other body
tissues to enlarge breast size.
RISKS of AUGMENTATION MAMMAPLASTY SURGERY
Every surgical procedure involves a certain amount of risk
and it is important that you understand the risks involved
with augmentation mammaplasty. Additional information
concerning breast implants may be obtained from the FDA,
package-insert sheets supplied by the implant manufacturer,
or other information pamphlets required by individual state
laws.
An individual's choice to undergo a surgical procedure is
based on the comparison of the risk to potential benefit.
Although the majority of women 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 breast
augmentation. Problems associated with breast implants can
be inherent to this type of implanted medical device or
relate to complications of a surgical procedure. Additional
advisory information regarding this subject should be
reviewed by patients considering surgery that involves
breast implants.
While every patient experiences her own individual risks and
benefits following breast implant surgery, clinical data
suggests that most women will be satisfied with the outcome
of breast implant surgery despite the occurrence of problems
inherent with breast implant surgery.
Inherent Risks of Breast Implants:
Implants- Breast implants, similar to other medical devices,
can fail. Implants can break or leak. Rupture can occur as a
result of an injury, from no apparent cause, or during
mammography. It is possible to damage an implant at the time
of surgery. Damaged or broken implants cannot be repaired.
Ruptured or deflated implants require replacement or
removal.
Capsular contracture- Scar tissue, which forms internally
around the breast implant as a foreign body reaction to seal
off the implant, can tighten and make the breast round,
firm, and possibly painful. Excessive firmness of the
breasts can occur soon after surgery or years later. The
occurrence of symptomatic capsular contracture is not
predictable. The incidence of symptomatic capsular
contracture can be expected to increase over time. Capsular
contracture may occur on one side, both sides or not at all.
It is more common with implant placement in front of the
chest muscle layer. Treatment for capsular contracture may
require surgery, implant replacement, or implant removal.
Capsular contracture may reoccur after surgical Procedimiento
to treat this condition.
Skin wrinkling and rippling- Visible and palpable wrinkling
of implants can occur. Some wrinkling is normal and
expected. This may be more pronounced in patients who thin
breast tissue. Wrinkling and/or folds may be confused with
palpable tumors and questionable cases must be investigated.
An implant may become visible at the surface of the breast
as a result of the device pushing though layers of skin.
Change in nipple and skin sensation- Some change in nipple
sensation is not unusual right after surgery. After several
months, most patients have normal sensation. Partial or
permanent loss of nipple and skin sensation may occur
occasionally. Changes in sensation may affect sexual
response or the ability to breast feed a baby.
Calcification- Calcium deposits can form in the scar tissue
surrounding the implant and may cause pain, firmness, and be
visible on mammography. These deposits must be identified as
different from calcium deposits that are a sign of breast
cancer. Should this occur, additional surgery may be
necessary to remove and examine calcifications.
Implant displacement- Displacement, rotation, or migration
of a breast implant may occur from its initial placement and
can be accompanied by discomfort and/or distortion in breast
shape. Unusual techniques of implant placement may increase
the risk of displacement or migration. Additional surgery
may be necessary to correct this problem.
Surface contamination of implants- Skin oil, lint from
surgical drapes, or talc may become deposited on the surface
of the implant at the time of insertion. The consequences of
this is unknown.
Breast feeding- Breast milk is the best food for babies.
Many women with breast implants have successfully breast fed
their babies. It is not known if there are increased risks
in nursing for a woman with breast implants. A study
measuring elemental silicon (a component of silicone) in
human breast milk did not indicate higher levels from women
with silicone-filled gel implants when compared to women
without implants.. Cow’s milk contains higher levels of
elemental silicon as compared to human milk. Implant
placement techniques that involve incisions through the
nipple and areolar locations may reduce the ability to
successfully breast feed. If a woman has undergone a
mastectomy, it is unlikely that she would be able to breast
feed a baby on the side where the breast was removed.
Unusual activities and occupations- Activities and
occupations which have the potential for trauma to the
breast could potentially break or damage breast implants, or
cause bleeding/seroma.
Inherent Surgical Risk of Breast Implant Surgery:
Bleeding- It is possible, though unusual, to experience a
bleeding episode during or after surgery. Should
post-operative bleeding occur, it may require emergency
treatment to drain accumulated blood (hematoma). Do not take
any aspirin or anti-inflammatory medications for ten days
before surgery, as this may increase the risk of bleeding.
Non-prescription "herbs" and dietary supplements can
increase the risk of surgical bleeding. Hematoma can occur
at any time following injury to the breast.
Seroma- Fluid may accumulate around the implant following
surgery, trauma or vigorous exercise. Additional treatment
may be necessary to drain fluid accumulation around breast
implants. This may contribute to infection, capsular
contracture, or other problems.
Infection- Infection is unusual after this type of surgery.
It may appear in the immediate post operative period or at
any time following the insertion of a breast implant.
Subacute or chronic infections may be difficult to diagnose.
Should an infection occur, treatment including antibiotics,
possible removal of the implant, or additional surgery may
be necessary. Infections with the presence of a breast
implant are harder to treat than infections in normal body
tissues. If an infection does not respond to antibiotics,
the breast implant may have to be removed. After the
infection is treated, a new breast implant can usually be
reinserted. It is extremely rare that an infection would
occur around an implant from a bacterial infection elsewhere
in the body, however, prophylactic antibiotics may be
considered for subsequent dental or other
surgical Procedimiento. In extremely rare instances,
life-threatening infections, including toxic shock syndrome
have been noted after breast implant surgery.
Skin scarring- Excessive scarring is uncommon. In rare
cases, abnormal scars may result. Scars may be unattractive
and of different color than surrounding skin. Additional
surgery may be needed to treat abnormal scarring after
surgery.
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
or sedation.
Allergic reactions- In rare cases, local allergies to tape,
suture material, 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.
Thrombosed veins- Thrombosed veins, which resemble cords,
occasionally develop in the area of the breast and resolve
without medical or surgical treatment.
Pain- Pain of varying intensity and duration may occur and
persist after breast implant surgery. Pain may be the result
of improper implant size, placement, surgical technique,
capsular contracture, or sensory nerve entrapment or injury.
Additional Breast Implant Advisory Information:
Breast cancer- Current medical information does not
demonstrate an increased risk of breast cancer in women who
have breast implant surgery for either cosmetic or
reconstructive purposes. It is recommended that all women
perform periodic self examination of their breasts, have
mammography according to American Cancer Society guidelines,
and seek professional care should they notice a breast lump.
Care must be exercised during breast biopsy Procedimiento to
avoid damaging the breast implant.
Mammography- Breast implants may make mammography more
difficult and may obscure the detection of breast cancer.
Implant rupture can occur from breast compression during
mammography. Inform your mammography technologist of the
presence of breast implants so that appropriate mammogram
studies may be obtained. Patients with capsular contracture
may find mammogram techniques painful and the difficulty of
breast imaging will increase with the extent of contracture.
Ultrasound, specialized mammography and MRI studies may be
of benefit to evaluate breast lumps and the condition of the
implant(s). ). Because more x-ray views are necessary with
specialized mammography techniques, women with breast
implants will receive more radiation than women without
implants who receive a normal exam. However, the benefit of
the mammogram in finding cancer outweighs the risk of
additional x-rays. Patients may wish to undergo a
preoperative mammogram and another one after implantation to
establish a baseline view of their breast tissue.
Second generation effects- A review of the published medical
literature regarding potential damaging effect on children
born of mothers with breast implants is insufficient to draw
definitive conclusions that this represents a problem.
Long term results- Subsequent alterations in breast shape
may occur as the result of aging, weight loss or gain,
pregnancy, or other circumstances not related to
augmentation mammaplasty. Breast sagginess may normally
occur.
Unsatisfactory result- You may be disappointed with the
results of surgery. Asymmetry in implant placement,
displacement, nipple location, unanticipated breast shape
and size may occur after surgery. Breast size may be
incorrect. Unsatisfactory surgical scar location may occur.
It may be necessary to perform additional surgery to improve
your results or remove implants.
Removal / replacement of breast implants- Future revision,
removal, or replacement of breast implants and the
surrounding scar tissue envelope involves surgical
Procedimiento with risks and potential complications. There may
be an unacceptable appearance of the breasts following
removal of the implant.
Capsule Procedimiento- Closed capsulotomy, the process of
forcefully squeezing the fibrous capsule around a breast
implant to break up scarring is not recommended. This may
result in rupture of the breast implant or other
complications.
Immune system diseases and unknown risks- A small number of
women with breast implants have reported symptoms similar to
those of known diseases of the immune system, such as
systemic lupus erythematosis, rheumatoid arthritis,
scleroderma, and other arthritis-like conditions. To date,
after several large epidemiological studies of women with
and without implants, there is no scientific evidence that
women with either silicone gel-filled or saline-filled
breast implants have an increased risk of these diseases.
These diseases appear no more common in women with implants
than those women without implants. The effects of breast
implants in individuals with pre-existing immune system and
connective-tissue disorders are unknown. There is the
possibility of unknown risks associated with silicone breast
implants and tissue expanders.
HEALTH INSURANCE
Most health insurance companies exclude coverage for
cosmetic surgical operations such as the augmentation
mammaplasty and any complications that might occur from
surgery. Most insurance covers the first breast
reconstruction operation. Insurance coverage for future
revision, new breast implants, or additional doctor’s visits
may not be covered, depending on the policy. Health
insurance premiums may be dropped, premiums may increase, or
future coverage may be denied in patients with breast
implants. Please carefully review your health insurance
subscriber information pamphlet and underwriting policies.
ADDITIONAL SURGERY NECESSARY
Should complications occur, additional surgery or other
treatments may be necessary. Even though risks and
complications occur infrequently, the risks cited are
particularly associated with augmentation mammaplasty; other
complications and risks can occur but are even more
uncommon. 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 surgery involves several charges for the
services provided. The total includes fees charged by your
doctor, the cost of implants and surgical supplies,
anesthesia, laboratory tests, and possible outpatient
hospital charges, depending on where the surgery is
performed. Depending on whether the cost of surgery is
covered by an insurance plan, 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 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
AUGMENTATION MAMMAPLASTY, continued 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 Procedimiento
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 AUGMENTATION MAMMAPLASTY
_________________________________________________________.
2. I recognize that during the course of the operation and
medical treatment or anesthesia, unforeseen conditions may
necessitate different Procedimiento than those above. I
therefore authorize the above physician and assistants or
designees to perform such other Procedimiento 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 GoScuptura or any of the staff employed by
GoSculptura as to the results that may be obtained.
If any dispute may arise the surgeon is only liable if
litigation takes place in Argentina, under Argentinean Law.
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 Procedimiento OR METHODS OF
TREATMENT
c. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED
SIGN A OR B
A. I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE
LISTED ITEMS (1-6). I HAVE BEEN ASKED IF I WANT A MORE
DETAILED EXPLANATION, BUT I AM SATISFIED WITH THE
EXPLANATION, AND DO NOT WANT MORE INFORMATION.
_______________________________________________________________
Patient or Person Authorized to Sign for Patient
Date___________________________ Witness
_________________________
________________________________________
B. I CONSENT TO THE TREATMENT OR PROCEDURE AND ABOVE LISTED
ITEMS (1-6). I REQUESTED AND RECEIVED, IN SUBSTANTIAL
DETAIL, FURTHER EXPLANATION OF THE PROCEDURE OR TREATMENT,
OTHER ALTERNATIVE Procedimiento OR METHODS OF TREATMENT AND
INFORMATION ABOUT THE MATERIAL RISKS OF THE PROCEDURE OR
TREATMENT.
_______________________________________________________________
Patient or Person Authorized to Sign for Patient
Date __________________________ Witness
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GoSculptura ofrece paquetes de cirugía plástica en Argentina, como también cirugía plástica en Túnez a precios competitivos con los más importantes cirujanos plásticos certificados por los consejos profesionales en las principales clínicas de cirugía plástica en Argentina, como también clínicas de cirugía plástica en Túnez.
También ofrecemos cirugías de bypass gástrico, cirugías de fertilización in vitro, y odontología cosmética.
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