Risks
Possible Risks of Breast Augmentation and Study Participation
All surgical procedures have a small risk of complications inherent to the surgery itself and to anesthesia.
Major Surgery and Anesthesia Related Risks
· Anesthesia complications including allergic reactions and anaphylaxis
· Cardiac complications such as arrhythmia, myocardial infarction
· Pulmonary complications such as aspiration, atelectasis, pneumonia
· Pulmonary embolus
· Deep venous thrombosis
· Neurologic complications such as stroke, pressure neuropathy
· Death
The most common side effects of breast implants and operative breast procedures include:
Breast Implant Related Risks
· Capsule contracture
The scar tissue or capsule that normally forms around the implant may tighten and squeeze the implant and is called capsular contracture. Capsular contracture is more common following infection, hematoma and seroma. It is also more common with subglandular placement (behind the mammary gland and on top of the chest muscle). Symptoms range from mild firmness and mild discomfort to severe pain, distorted shape, palpability of the implant, and/or movement of the implant.
Additional surgery is needed in cases where pain and /or firmness is severe. This surgery ranges from removal of the implant capsule tissue to removal and possibly replacement of the implant itself. Capsular contracture may happen again after these additional surgeries.
· Capsule calcification and calcium deposits
Deposits of calcium can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery for biopsy and/or removal of the implant to distinguish calcium deposits from cancer.
· Wrinkling/scalloping
Wrinkling, scalloping and folding of the implant shell may occur. If the overlying tissue is thin, they may be palpable and/or visible. Folds may cause thinning and erosion of the overlying tissue, with possible extrusion of the implant. Also, folds may cause shell damage resulting in deflation of the implant.
· Spontaneous failure of the inner shell
Failure of the inner shell of the implant does not cause a decrease in implant fullness, but the implant will feel different (e.g. the edge may feel thicker and more palpable than previously). If this occurs, women should have the implant evaluated by their plastic surgeon. If there is a cosmetic concern, removal, with or without replacement, may be recommended.
· Spontaneous failure of the outer shell
Failure of the outer shell of the implant deflates just the outer cavity. This causes a slight decrease in implant fullness that may or may not be noticeable, but the implant will feel different (e.g. the edge may feel thicker and more palpable than previously). The saline is absorbed by the body. If this occurs, women should have the implant evaluated by their plastic surgeon. If there is a cosmetic concern, removal, with or without replacement, may be recommended.
· Spontaneous deflation
Failure of the inner and outer shells deflates both the inner and outer cavities. This causes a significant decrease in implant fullness that makes the breast appear noticeably smaller. The saline is absorbed by the body. If this occurs, women should have the implant removed, with or without replacement. If the deflated implant is replaced promptly, before the capsule contracts, the procedure may be done using local anesthesia in the area of the original incision, rather than general anesthesia or intravenous sedation.
Implant deflation can occur immediately or slowly over a period of days and is noticed by loss of size or shape of the breast. Some implants deflate in the first few months after being implanted and some deflate after several years. Causes of deflation include damage by surgical instruments during surgery, overfilling or underfilling of the implant with saline solution, capsular contracture, closed capsulotomy, stresses such as trauma or intense physical manipulation, excessive compression during mammographic imaging, umbilical incision placement, and unknown/unexplained reasons. Women should be aware that the breast implant may wear out over time and deflate.
· Seroma
A seroma is an accumulation of fluid around an implant. Symptoms may include swelling and pain. A seroma may contribute to infection or subsequent capsule contracture. The body will absorb small amounts of fluid, but large amounts may have to be drained surgically and may result in a small scar. Implant deflation can occur from surgical draining if damage to the implant occurs during the draining procedure.
· Breast tissue atrophy/chest wall deformity
The pressure of a breast implant may cause the breast tissue to thin and shrink. This can occur while implants are still in place or following implant removal without replacement.
· Interference with mammography
The implant may interfere with finding breast cancer during mammography and also may make it difficult to perform mammography. Therefore, it is essential that women tell their mammography technologist that they have an implant before the procedure. The technologist can use special techniques to minimize the possibility of rupture and to get the best possible views of the breast tissue. Because the breast is squeezed during mammography, it is possible for an implant to rupture during the procedure. More x-ray views are necessary with these special techniques; therefore, women with breast implants will receive more radiation. However, the benefit of the mammogram in finding cancer outweighs the risk of the additional x-rays.
· Dissatisfaction with cosmetic results
Dissatisfying results such as wrinkling, asymmetry, implant displacement (shifting), incorrect size, unanticipated shape, implant palpability, scar deformity and/or hypertrophic (irregular, raised scar) scarring may occur. Careful surgical planning and technique can minimize but not always prevent such results.
Subsequent operation related to breast implant - Women should understand there is a chance they will need to have a subsequent operation(s) at some time related to an implant problem such as capsule contracture, spontaneous deflation, wrinkling or seroma. Many women decide to have the implants replaced, but some women do not. Those who do not may have cosmetically unacceptable dimpling and/or puckering of the breast following implant removal. Implant replacement increases the risk of complications such as capsule contracture and the need for subsequent operations.
Breast Procedure Related Risks
· Hematoma/bleeding
A hematoma is an accumulation of blood around an implant. Swelling, pain and bruising may result. If a hematoma occurs, it will usually be soon after surgery. However, this can also occur at any time after injury to the breast. A hematoma may contribute to infection or subsequent capsule contracture. The body will absorb small amounts of blood, but large amounts may have to be drained surgically and may result in a small scar. Implant deflation can occur from surgical draining if damage to the implant occurs during the draining procedure.
· Wound healing delay, tissue necrosis, dehiscence (no exposure)
In some cases, an incision fails to heal normally. Necrosis is the formation of dead tissue around the implant. This may prevent wound healing and require surgical correction and/or implant removal. Permanent scar deformity may occur following necrosis. Factors associated with increased necrosis include infection, use of steroids in the surgical pocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy.
· Wound infection (not peri-prosthetic)
Infection can occur with any surgery. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. An infection may be limited to the skin and breast tissue (not peri-prosthetic) or may involve the implant (peri-prosthetic). In rare instances, toxic shock syndrome has been noted after breast implant surgery, and it is a life-threatening condition that requires immediate medical care. Symptoms include sudden fever, diarrhea, vomiting, dizziness, fainting and/or sunburn-like rash. A doctor should be seen immediately for diagnosis and treatment for this condition.
· Peri-prosthetic infection (no exposure)
An infection may involve the implant (peri-prosthetic). Infections with an implant present are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed, and another implant may be placed after the infection is resolved.
· Septicemia
Severe infection on rare occasions can result in septicemia, an infection that spreads in the blood stream throughout the body.
· Implant exposure/extrusion
Unstable or compromised tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin.
· Skin scar unsatisfactory
Any incision in the skin will leave a scar that is permanent. While plastic surgical techniques make this as inconspicuous as possible, some patients have skin that results in more conspicuous or thick (hypertrophic) scars and/or pigment changes no matter how the incision is repaired. Such scars may be of cosmetic concern.
· Mastopexy unsatisfactory
A breast uplift procedure (mastopexy) may result in unsatisfactory elevation of the breast tissue, position of the nipple, breast shape and/or skin scars.
· Implant position unsatisfactory (malposition)
An implant may be placed in an unsatisfactory position at the implantation procedure or may shift to an unsatisfactory position over time due to gravity, scarring, capsule contracture, stretching and/or thinning of tissues.
· Persistent breast pain
Pain of varying intensity and duration may occur and persist following breast implant surgery. In addition, improper size, placement, surgical technique, or capsular contracture may result in pain associated with nerve entrapment or interference with muscle motion. Women should tell their surgeon about severe pain.
· Nipple/breast sensitivity change
Feeling in the nipple and breast can increase or decrease after implant surgery. The range of changes varies from intense sensitivity to no feeling in the nipple or breast following surgery. Changes in feeling can be temporary or permanent and may affect a woman's sexual response or their ability to nurse a baby.
· Lactation problem
Breast surgery, including breast biopsy and implantation, can have an adverse effect on the adequacy of a woman’s milk supply, although many women with breast implants have nursed their babies successfully.
· Lymphadenopathy
Infection can result in enlargement of regional lymph nodes (lymphadenopathy).
Subsequent operation related to surgical procedure for implant placement - Women should understand there is a chance they will need to have subsequent operations at some time related to problems from the surgical procedure for implant placement. Examples include control of bleeding or treatment of an infection.
Other Reported Conditions and Risks
· Dissatisfaction with implant size selected – bilateral
At any time following implantation, the patient and/or surgeon may become dissatisfied with the size of the implants selected before or at the time of surgery. Changing the size of the implants requires a subsequent operation and also may involve a procedure to adjust the size of the implant capsules.
· Dissatisfaction with implant size selected - unilateral (asymmetry)
At any time following implantation, the patient and/or surgeon may become dissatisfied with the symmetry of size of the breasts due to the size of the implants selected before or at the time of surgery. Changing the size of one or both implants requires a subsequent operation and also may involve a procedure to adjust the size of one or both implant capsules.
· Trauma to implant – surgical procedure
Implant deflation may result from accidental damage to the shell with surgical instruments during procedures such as breast biopsy.
· Trauma to implant – external
Implant deflation may result from external trauma such as from an automobile airbag or the compression required for mammography.
· Breast ptosis - after implant placement due to pregnancy, weight change and/or breast size change
Breast ptosis (droop) is caused by the effects of gravity over time, the effects of pregnancy, change in weight and/or change in breast size. Breast ptosis may be present before or become apparent after implantation. Correction requires a subsequent operation.
· Breast lesion – benign
There is no evidence of increased risk of benign breast tumors associated with breast implants.
· Breast lesion – malignant
Published studies indicate that breast cancer is no more common in women with implants than those without implants.
· Connective tissue disease (CTD) diagnosis
Concern over the association of breast implants to the development of autoimmune or connective tissue diseases, such as lupus, scleroderma, or rheumatoid arthritis, was raised because of cases reported in the literature of small numbers of women with implants. A review of several large epidemiological studies of women with and without implants indicates that these diseases are no more common in women with implants than those in women without implants. However, a lot of women with breast implants believe that their implants caused a connective tissue disease.
· Reproduction problem
There have been concerns raised regarding potential damaging effects on children born of mothers with implants. A review of the published literature on this issue suggests that the information is insufficient to draw definitive conclusions.
· Suicide
An increased rate of suicide has been reported in women with breast implants. The reason for this is unknown, but some studies have found an increased history of psychiatric problems prior to surgery.
Subsequent operation unrelated to breast implant or breast procedure - Women should understand there is a chance they will need to have a subsequent operation(s) at some time for problems unrelated to the implant or the breast procedure. Examples include change in implant size or replacement due to trauma to the implant.
Unforseeable Risks
The use of this study device may involve risks that are presently unforeseen and unknown. Also, any medication may trigger a serious allergic or other reaction and may cause rash, hives, itching, tingling and swelling of the face, lips, tongue, throat and/or vocal cords, difficulty breathing, wheezing, very low blood pressure, seizures (convulsions), loss of consciousness, and possibly death. Medications may cause temporary changes in blood chemistries and other blood tests.
Rare or unknown side effects could possibly occur, including life-threatening reactions.
|