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Informed Consent


This informed consent document has been prepared to help your plastic surgeon 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. 

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 afterward. 

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 federal law. 

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. 

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 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. 

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. 

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. 

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 necessary. 

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). 

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. 

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. 

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 tissue expanders. 

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 has been reported secondary to the use of tissue expanders and breast implants.  The consequences of chest wall deformity are of unknown significance. 

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 complications. 

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. 

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 be obtained. 

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. 



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