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 package-insert sheets supplied by the implant manufacturer.
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 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 implants may require replacement or removal. Breast implants can wear out, they cannot be expected to last for ever.
Capsular contracture – 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. Treatment for capsular contracture may require surgery, implant replacement, or implant removal. Capsular contracture may reoccur after surgical procedures to treat this condition.
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 or cold therapy. In some cases, incision sites fail to heal normally. An implant may become visible at the surface of the breast as a result of the device pushing though layers of skin. If tissue breakdown 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 can occur. Some wrinkling is normal and expected. This may be more pronounced in patients who have saline-filled implants with textured surfaces or thin breast tissue. Some patients may find wrinkles cosmetically undesirable. Palpable valve, 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.
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 is of unknown significance.
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 procedures. 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 from surrounding skin. Additional surgery may be needed to treat abnormal scarring after surgery.
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.
Surgical anaesthesia – Both local and general anaesthesia involve risk. There is the possibility of complications, injury, and even death from all forms of surgical anaesthesia or sedation.
Delayed healing – Wound disruption or delayed wound healing is possible.
Smokers have a greater risk of skin loss and wound healing complications.
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 procedures 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 procedures with risks and potential complications. There may be an unacceptable appearance of the breasts following removal of the implant.
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 is unknown. There is the possibility of unknown risks associated with silicone breast implants and tissue expanders.
Capsule procedures – 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.
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 breast augmentation; 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.
Deep Venous Thrombosis, Cardiac and Pulmonary Complications: Surgery, especially longer procedures, may be associated with the formation of, or increase in, blood clots in the venous system. Pulmonary complications may occur secondarily to blood clots (pulmonary emboli), fat deposits (fat emboli) or partial collapse of the lungs after general anaesthesia. Pulmonary and fat emboli can be life threatening or fatal in some circumstances. Air travel, inactivity and other conditions may increase the incidents of blood clots travelling to the lung causing a major blood clot that may result in death. It is important to discuss with your surgeon any past history of blood clots of swollen legs 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 pain or unusual heart beats, seek medical attention immediately. Should any of these complications occur, you might require hospitalisation and additional treatments.
Smoking, second-Hand Smoke Exposure, Nicotine Products (Patch, Gum, Nasal spray): Patients who are currently smoking, use tobacco products, or nicotine products are at a greater risk for significant surgical complications of skin dying, delay the healing and additional scarring. Individuals exposed to second hand smoke are also at potential risk for similar complications attributable to nicotine exposure. Additionally, smokers may have a significant negative effect from anaesthesia and recovery from anaesthesia, 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.
It is important to refrain from smoking at least six weeks before surgery and until your surgeon states it is safe to return, if desired.
Female patients information: It is important to inform your surgeon if you use birth control pills, estrogen replacement, or if you believe you may be pregnant. Many medications including antibiotics may neutralize the preventive effects of birth control pills, allowing for conception and pregnancy.
Intimate Relations after Surgery: Surgery involves coagulating of blood vessels and increased activity of any kind may open these vessels leading to a bleed or hematoma. Increased activity that increases your pulse or heart rate may cause additional bruising, swelling and the need for return to surgery and control of bleeding. It is wise to refrain from sexual activity until your surgeon states it is safe.
Medications: There are many adverse reactions that occur as the result of taking over the counter, herbal, and/or prescription medications. Be sure to check with your surgeon about any drug interactions that may exist with medication that you are already taking. If you have an adverse reaction, stop the medication immediately and call your surgeon for further instructions. If the reaction is severe, go immediately to the nearest hospital. When taking the prescribed pain medication after surgery, realize that they can affect your thought process. Do not drive, do not operate complex equipment, do not make any important decisions and do not drink any alcohol while taking these medications. Be sure to take your prescribed medication only as directed.