This informed consent document has been prepared to help your plastic surgeon
inform you about augmentation mammaplasty, its risks, and alternative
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
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
As a reconstructive technique for various conditions
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
Silicone gel-filled implants are no longer widely available for
purely cosmetic breast augmentation. Silicone
gel-filled implants are available for some conditions within a study protocol
supervised by the United States Food and Drug Administration (FDA). Saline-filled breast implants are still
widely available for cosmetic breast augmentation. The FDA has recently approved the use of
Silicone Breast Implants. Please ask
your doctor for additional information.
All breast implants are subject to device tracking according to
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. The
method of inserting and positioning breast implants will depend on your
preferences, your anatomy and your surgeon’s recommendation.
Augmentation mammaplasty is an elective surgical operation. Alternative treatment would consist of not
undergoing the surgical procedure, 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
may be obtained from the FDA, package insert sheets supplied by the implant
manufacturer, or other information pamphlets required by individual state
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.
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
or blood transfusion. Do not take any
aspirin or anti-inflammatory medications for ten days before surgery, as this
may increase the risk of bleeding.
Infection is unusual after this type of surgery. Should an infection occur, treatment
including possible removal of the implant, antibiotics or additional surgery
may be necessary. It is extremely rare
that an infection would occur around an implant from a bacterial infection
elsewhere in the body.
Scar tissue, which forms internally around the breast 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. Although
the occurrence of symptomatic capsular contracture is not predictable, it
generally occurs in less than 20 percent of patients. 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. Treatment
for capsular contracture may require surgery, implant replacement, or implant
removal. External pressure (closed
capsulotomy) may break up scarring, but can potentially rupture the implant.
CHANGE IN NIPPLE AND
Breasts are usually sore after surgery.
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.
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.
Breast implants, similar to other medical devices, can fail. Implants can break or leak. When a saline-filled implant deflates, its
salt water filling will be absorbed by the body. 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. Breast implants do not have an indefinite
lifespan and will eventually require replacement surgery.
DEGRADATION OF BREAST
It is possible that small pieces of the implant material may separate from
the outer surface of breast implants. This
is of unknown significance.
Lack of adequate tissue coverage or infection may result in exposure and
extrusion of the implant. Skin
breakdown has been reported with the use of steroid drugs or after radiation
therapy to breast tissue. If tissue
breakdown occurs and the implant becomes exposed, implant removal may be
If you are over 35 years of age, pre-operative mammography is recommended
prior to surgery. Post-operative
mammography is performed according to American Cancer Society guidelines. 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 radiologist of the presence of breast implants so that appropriate
mammogram studies may be obtained. Ultrasound,
specialized mammography and MRI studies may be of benefit to evaluate breast
lumps and the condition of the implant(s).
SKIN RIPPLING AND
Visible and palpable wrinkling of implants can occur. Some wrinkling is normal and expected. This may be more pronounced in patients who
have saline-filled implants or thin breast tissue.
PREGNANCY AND BREAST
There is insufficient evidence regarding the absolute safety of breast
implants in relation to fertility, pregnancy or breast feeding. While there is no convincing evidence of
any special danger of breast implants for pregnant women or their children,
studies are continuing to look for possible problems.
Calcium deposits can form in the tissue surrounding the implant and may cause
pain, firmness, and is visible on mammography. Should this occur, additional surgery may
be necessary to correct his problem.
IMMUNE SYSTEM DISEASES
AND UNKNOWN DISORDERS
Some 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. These symptoms include joint pain or
swelling, fever, fatigue, thyroid problems, breast pain and musculoskeletal
pain. A connection between implanted
silicone and connective-tissue disorders has been reported in the medical
literature. To date, there is no
scientific evidence that women with either silicone gel-filled or
saline-filled breast implants have an increased risk of these diseases, but
the possibility cannot be excluded. If
a causal relationship is established, the theoretical risk of immune and
unknown disorders may be low. The effects
of breast implants in individuals with pre-existing connective-tissue
disorders are unknown.
Unlike silicone gel-filled implants, the saline-filled implants
contain salt water. Any risk related
to silicone gel would not be associated with saline-filled implants. However, gel-filled and saline-filled
devices have a silicone rubber envelope.
An increased risk of autoimmune disease is possible even from saline
implants. Reliable medical laboratory
tests to determine antibodies to silicone do not exist. It has not been proved that there is a
relationship between silicone antibodies and disease in women with breast
implants. Currently, there is
insufficient evidence to state that there is a health benefit from removing
breast implant(s) and scar-tissue capsule(s) will alter autoimmune disease or
prevent its potential occurrence.
In very few women who have breast implants, a variety of other
symptoms and conditions have been reported, suggestive of an auto-immune
multiple-sclerosis-like syndrome. Additional
complaints involve the musculoskeletal, skin, nervous, and immune systems. The relationship of breast implants to
these conditions has been hypothesized, although not scientifically proven. Because such disease states are rare, they
are difficult to research. There is
the possibility of unknown risks associated with silicone breast implants and
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 are unknown.
CHEST WALL DEFORMITY
Chest wall deformity has been reported secondary to the use of tissue
expanders and breast implants. The consequences
of chest wall deformity are of unknown significance.
UNUSUAL ACTIVITIES AND
Activities and occupations which have the potential for trauma to the breast
could potentially break or damage breast implants.
In rare cases, local allergies to tape, suture material, or topical
preparations have been reported. Systemic
reactions which are more serious may occur to drugs used during surgery and
prescription medicines. Allergic
reactions may require additional treatment.
Current medical information does not demonstrate an increased risk of breast
disease or breast cancer in women who have breast implant surgery for either
cosmetic or reconstructive purposes. Breast
disease can occur independently of breast implants. It is recommended that all women perform
periodic self examination of their breasts, have mammography according to
American Cancer Society guidelines, and to seek professional care should they
notice a breast lump.
Future removal or replacement of breast implants and the surrounding scar
tissue envelope involves a surgical procedure with risks and potential
Both local and general anesthesia involves risk. There is the possibility of complications,
injury, and even death from all forms of surgical anesthesia or sedation.
Most health insurance companies exclude coverage for cosmetic surgical
operations such as the augmentation mammaplasty or any complications that
might occur from surgery. Some
insurance carriers may exclude breast diseases in patients who have breast
implants. Please carefully review your
health insurance subscriber information pamphlet.
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 any guarantee or warranty expressed or implied, on the results that may
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.
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 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.