This is an informed-consent document that has been prepared to help inform you about augmentation mammaplasty surgery, its risks, as well as alternative treatment(s).
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 and agreed upon by you.
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 correct or improve results of 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 United States Food and Drug Administration (FDA), a woman must be at least 18 years of age for cosmetic breast augmentation with saline-filled breast implants. There is no age restriction on breast reconstruction procedures to restore breast shape after cancer, trauma, or severe breast abnormalities.
Breast enlargement is accomplished by inserting a breast implant either behind the breast tissue or partially or completely 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. When breast implants are inserted during the breast reconstruction process, tissue expanders are used to stretch healthy skin in order to provide coverage for a breast implant. 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 your surgeon’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 that involve sagging of the breast or diminished skin tone (stretch marks) may require additional surgical procedures (breast lift) to reposition the nipple and areola upward and to remove loose skin.
Patients undergoing augmentation mammaplasty surgery must consider the following:
- Breast augmentation or reconstruction with saline-filled implants may not be a onetime surgery.
- Breast implants of any type are not considered lifetime devices. They cannot be expected to last forever. You will likely require future surgery for implant replacement or removal.
- 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.
- Large volume primary augmentation or revision with larger sized implants in excess of dimensional planning for your chest and breast size may increase the risk of complications such as implant extrusion, hematoma, infection, palpable implant folds, and visible skin wrinkling requiring surgical intervention to correct these complications.
Alternative forms of management include not treating the skin laxness and bagginess in the eyelids by surgery. Improvement of skin laxness, fatty deposits and skin wrinkles may be accomplished by other treatments or surgery such as a brow lift when indicated. Other forms of eyelid surgery may be needed should you have 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, laser resurfacing, or other skin treatments. Risks and potential complications are associated with alternative surgical forms of treatment.
INHERENT RISKS OF AUGMENTATION MAMMAPLASTY SURGERY
Every surgical procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. 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 patients do not experience these complications, you should discuss each of them with your plastic surgeon to make sure you understand all possible 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 the surgery.
SPECIFIC RISKS OF SALINE-FILLED BREAST IMPLANTS
Breast implants, similar to other medical devices, can fail. When a saline-filled implant ruptures, the saline material is absorbed by the body, but the shell material remains. Rupture can occur as a result of an injury, from no apparent cause (silent rupture), or during mammography. It is possible to damage an implant at the time of surgery. Damaged or broken implants cannot be repaired. Ruptured or damaged
implants require replacement or removal. Breast implants can wear out, they are not guaranteed to last a lifetime and future surgery may be required to replace one or both implants. An MRI (magnetic resonance imaging) study may be necessary to evaluate the possibility of implant rupture or deflation, yet may not be 100% accurate in diagnosing implant integrity. Saline-filled breast implants may not have the
same contour or feel as silicone-filled breast implants. The shape of your breasts after surgery depends on many factors such as your skin thickness, position, placement of the implants, and technique. You should discuss with your surgeon the possibility of a different and less than desirable contour-shape as well as feel of your result.
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. 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 procedures to treat this condition and it occurs more often in revision augmentation than primary augmentation. Some surgeons believe that preventative antibiotics during dental work and treatment for sinus infections and urinary tract infections may decrease this incidence. Discuss this with your surgeon. There may be an Off-Label FDA use for a drug called Singulair, which may have a softening effect on the capsule.
Implant Extrusion / Tissue Necrosis:
Lack of adequate tissue coverage or infection may result in exposure and extrusion of the implant through the skin. Tissue breakdown (necrosis) has been reported with the use of steroid drugs, after chemotherapy/radiation to breast tissue, due to smoking, microwave diathermy, and excessive heat orcold therapy. In some cases, incision sites fail to heal normally. Atrophy of breast tissue may occur. An implant may become visible at the surface of the breast as a result of the device pushing though layers of skin. If tissue break down occurs and the implant becomes exposed, implant removal may be necessary. Permanent scar deformity may occur.
Skin Wrinkling and Rippling:
Visible and palpable wrinkling of implants and breast skin can occur. Some wrinkling is normal and expected with saline-filled breast implants. This may be more pronounced in patients who have saline-filled implants with textured surfaces or thin breast tissue. It may be possible to feel the implant fill valve. Some patients may find palpable valve and wrinkles cosmetically undesirable. Palpable valve, wrinkling and/or folds may be confused with palpable tumors and questionable cases must be investigated.
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.
Chest Wall Irregularities:
Chest wall irregularities have been reported secondary to the use of tissue expanders and breast implants. Residual skin irregularities at the ends of the incisions or “dog ears” are always a possibility when there is excessive redundant skin. This may improve with time, or it can be surgically corrected.
Implant Displacement and Tissue Stretching:
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 (visible rippling of the skin). Unusual techniques of implant placement may increase the risk of displacement or migration. Additional surgery may be necessary to attempt to correct this problem. It may not be possible to resolve this problem once
it has occurred.
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 are unknown.
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.
Change in Nipple and Skin Sensation:
You may experience a diminished (or loss of) sensitivity of the nipples and the skin of your breast. 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.
Anaplastic Large Cell Lymphoma (ALCL):
Women with saline and silicone gel breast implants may have a very small and possibly increased risk of developing anaplastic large cell lymphoma (ALCL) in the scar capsule adjacent to the implant. This is a very rare disease and is currently being investigated as to its relationship to breast implants, and whether this is even a cancer or a Lymphoproliferative Disorder. ALCL is an extremely rare cancer of the immune system which can occur anywhere in the body. The National Cancer Institute estimated 1 in 500,000 women per year in the U.S. are diagnosed with ALCL. ALCL in the breast is even rarer with approximately 3 in 100 million women in U.S diagnosed per year. The relationship between breast implants and ALCL is unclear and is currently under investigation. In most cases, women observed
changes in the look or feel of the area surrounding the implant after their initial surgical sites were fully healed. Patients with breast implants should be followed by a surgeon over time and seek professional care for implant-related symptoms such as pain, lumps, swelling, or asymmetry. Patients should monitor their breast implants with routine breast self exams and follow standard medical recommendations for imaging (e.g. Mammography, Ultrasound, MRI). Abnormal screening results or implant-related symptoms may result in additional costs and expenses for tests and/or procedures to properly diagnose and treat your condition. Tests and procedures could include but may not be limited to: obtaining breast fluid or tissue for pathology and laboratory evaluation and surgery to remove the scar capsule around the breast implant, implant removal or implant replacement.
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. Individuals with a personal history or family history of breast cancer may be at a higher risk of developing breast cancer than a woman with no family history of this disease. 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 a breast lump be detected. In the event that suspicious tissue is identified prior to or during breast surgery, additional tests and therapy with corresponding expenses may be warranted.
GENERAL RISKS OF SURGERY
Certain medical conditions, dietary supplements and medications may delay and interfere with healing. Patients with massive weight loss may have a healing delay that could result in the incisions coming apart, infection, and tissue changes resulting in the need for additional medical care, surgery, and prolonged hospitalizations. Patients with diabetes or those taking medications such as steroids on an extended basis may have prolonged healing issues. Smoking will cause a delay in the healing process, often resulting in the need for additional surgery. There are general risks associated with healing such as swelling, bleeding, possibility of additional surgery, prolonged recovery, color changes, shape changes, infection, not meeting patient goals and expectations, and added expense to the patient. There may also be a longer recovery due to the length of surgery and anesthesia. Patients with significant skin laxity (patients seeking facelifts, breast lifts, abdominoplasty, and body lifts) will continue to have the same lax skin after surgery. The quality or elasticity of skin will not change and recurrence of skin looseness will occur at some time in the future, quicker for some than others. There are nerve endings that may become involved with healing scars from surgery such as suction-assisted lipectomy, abdominoplasty, facelifts, body lifts, and extremity surgery. While there may not be a major nerve injury, the small nerve endings during the healing period may become too active producing a painful or oversensitive area due to the small sensory nerve involved with scar tissue. Often, massage and early non-surgical intervention resolves this. It is important to discuss post-surgical pain with your surgeon.
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 you may require a blood transfusion, though such occurrences are rare. Increased activity too soon after surgery can lead to increased chance of bleeding and additional surgery. It is important to follow postoperative instructions and limit exercise and strenuous activity for the instructed time. Do not take any aspirin or anti-inflammatory medications for at least ten days before or after 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, usually in the first three weeks following injury to the operative area. If blood transfusions are necessary to treat blood loss, there is the risk of blood-related infections such as hepatitis and HIV (AIDS). Heparin medications that are used to prevent blood clots in veins can produce bleeding and decreased blood platelets.
Infection is unusual after surgery. Should an infection occur, additional treatment including antibiotics, hospitalization, or additional surgery may be necessary. It is important to tell your surgeon of any other infections, such as ingrown toenail, insect bite, or urinary tract infection. Remote infections, infection in other part of the body, may lead to an infection in the operated area.
All surgery leaves scars, some more visible than others. Although good wound healing after a surgical procedure is expected, abnormal scars may occur within the skin and deeper tissues. Scars may be unattractive and of different color than the surrounding skin tone. Scar appearance may also vary within the same scar. Scars may be asymmetrical (appear different on the right and left side of the body). There is the possibility of visible marks in the skin from sutures. In some cases scars may require surgical revision or treatment.
Excessive firmness can occur after surgery due to internal scarring. The occurrence of this is not predictable. Additional treatment including surgery may be necessary.
Change in Skin Sensation:
It is common to experience diminished (or loss) of skin sensation in areas that have had surgery. Diminished (or complete loss of skin sensation) may not totally resolve.
Skin Contour Irregularities:
Contour and shape irregularities may occur. Visible and palpable wrinkling of skin may occur. Residual skin irregularities at the ends of the incisions or “dog ears” are always a possibility when there is excessive redundant skin. This may improve with time, or it can be surgically corrected.
Skin Discoloration / Swelling:
Some bruising and swelling will normally occur. The skin in or near the surgical site can appear either lighter or darker than surrounding skin. Although uncommon, swelling and skin discoloration may persist for long periods of time and, in rare situations, may be permanent.
Itching, tenderness, or exaggerated responses to hot or cold temperatures may occur after surgery. Usually this resolves during healing, but in rare situations it may be chronic.
Major Wound Separation:
Wounds may separate after surgery. Should this occur, additional treatment including surgery may be necessary.
Most surgical techniques use deep sutures. You may notice these sutures after your surgery. Sutures may spontaneously poke through the skin, become visible or produce irritation that requires suture removal.
Wound disruption or delayed wound healing is possible. Some areas of the skin may not heal normally and may take a long time to heal. Areas of skin may die. This may require frequent dressing changes or further surgery to remove the non-healed tissue. Individuals who have decreased blood supply to tissue from past surgery or radiation therapy may be at increased risk for wound healing and poor surgical outcome. Smokers have a greater risk of skin loss and wound healing complications.
Damage to Deeper Structures:
There is the potential for injury to deeper structures including nerves, blood vessels, muscles, and lungs (pneumothorax) during any surgical procedure. The potential for this to occur varies according to the type of procedure being performed. Injury to deeper structures may be temporary or permanent.
Fatty tissue found deep in the skin might die. This may produce areas of firmness within the skin. Additional surgery to remove areas of fat necrosis may be necessary. There is the possibility of contour irregularities in the skin that may result from fat necrosis.
Infrequently, fluid may accumulate between the skin and the underlying tissues following surgery, trauma or vigorous exercise. Should this problem occur, it may require additional procedures for drainage of fluid.
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.
In rare circumstances, your surgical procedure can cause severe trauma, particularly when multiple or extensive procedures are performed. Although serious complications are infrequent, infections or excessive fluid loss can lead to severe illness and even death. If surgical shock occurs, hospitalization and additional treatment would be necessary.
You will experience pain after your surgery. Pain of varying intensity and duration may occur and persist after surgery. Chronic pain may occur very infrequently from nerves becoming trapped in scar tissue or due to tissue stretching.
Cardiac and Pulmonary Complications:
Pulmonary complications may occur secondarily to blood clots (pulmonary emboli), fat deposits (fat emboli) or partial collapse of the lungs after general anesthesia. Pulmonary emboli can be life-threatening or fatal in some circumstances. Inactivity and other conditions may increase the incidence of blood clots traveling to the lungs causing a major blood clot that may result in death. It is important to discuss with your physician any past history of swelling in your legs or blood clots that may contribute to this condition. Cardiac complications are a risk with any surgery and anesthesia, even in patients without symptoms. If you experience shortness of breath, chest pains, or unusual heart beats, seek medical attention immediately. Should any of these complications occur, you may require hospitalization and
Venous Thrombosis and Sequelae:
Thrombosed veins, which resemble cords, occasionally develop in the area of the breast or around IV sites, and usually resolve without medical or surgical treatment. It is important to discuss with your surgeon any birth control pills you are taking. Certain high estrogen pills may increase your risk of thrombosed veins.
In rare cases, local allergies to tape, suture material and glues, blood products, topical preparations or injected agents have been reported. Serious systemic reactions including shock (anaphylaxis) may occur in response to drugs used during surgery and prescription medicines. Allergic reactions may require additional treatment.
Unexpected drug allergies, lack of proper response to medication, or illness caused by the prescribed drug are possibilities. It is important for you to inform your physician of any problems you have had with any medication or allergies to medication, prescribed or over the counter, as well as medications you now regularly take.
Symmetrical body appearance may not result after surgery. Factors such as skin tone, fatty deposits, skeletal prominence, and muscle tone may contribute to normal asymmetry in body features. Most patients have differences between the right and left side of their bodies before any surgery is performed. Additional surgery may be necessary to attempt to diminish asymmetry.
Surgical Wetting Solutions:
There is the possibility that large volumes of fluid containing dilute local anesthetic drugs and epinephrine that is injected into fatty deposits during surgery may contribute to fluid overload or systemic reaction to these medications. Additional treatment including hospitalization may be necessary.
Persistent Swelling (Lymphedema):
Persistent swelling can occur following surgery.
Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained. The body is not asymmetric and almost everyone has some degree of unevenness which may not be recognized in advance. One side of the face may be slightly larger, one side of the face droopier. The breast and trunk area exhibits the same possibilities. Many of such issues cannot be fully corrected with surgery. The more realistic your expectations as to results, the better your results will be in your eye. Some patients never achieve their desired goals or results, at no fault of the surgeon or surgery. You may be disappointed with the results of surgery. Asymmetry, unanticipated shape and size, loss of function, wound disruption, poor healing, and loss of sensation may occur after surgery. Size may be incorrect. Unsatisfactory surgical scar location or appearance may occur. It may be necessary to perform additional surgery to improve your results.
Smoking, Second-Hand Smoke Exposure, Nicotine Products (Patch, Gum, Nasal Spray):
Patients who are currently smoking or use tobacco or nicotine products (patch, gum, or nasal spray) are at a greater risk for significant surgical complications of skin dying and delayed healing and additional scarring. Individuals exposed to second-hand smoke are also at potential risk for similar complications attributable to nicotine exposure. Additionally, smoking may have a significant negative effect on anesthesia and recovery from anesthesia, with coughing and possibly increased bleeding. Individuals who are not exposed to tobacco smoke or nicotine-containing products have a significantly lower risk of this type of complication. Please indicate your current status regarding these items below: