As of May, 2000, saline-filled breast implant devices have been approved by the United States Food and Drug Administration (USFDA) for use in breast augmentation and reconstruction. Breast implants that contain silicone gel are currently restricted to women who meet eligibility criteria to participate in approved study programs.
Patients undergoing augmentation mammaplasty surgery must consider the following:
- Breast augmentation or reconstruction with saline-filled implants may not be a one time 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.
Augmentation mammaplasty is an elective surgical operation. Alternative treatment would consist of 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 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 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. 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 Saline Breast Implants:
Implants- 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 can wear out, they cannot be expected to last forever.
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. 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.
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. 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. 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 permanent loss of nipple and skin sensation may occur occasionally. Changes in sensation may affect sexual response or the ability to breastfeen a baby.
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 than surrounding skin. Additional surgery may be needed to treat abnormal scarring after surgery.
Surgical anesthesia: Both local and general anesthesia involve risk. There is the possibility of complications, injury, and even death from all forms of surgical anesthesia or sedation.
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.
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.
After the FDA banned the use of silicone breast implants for all patients, with the exception of certain candidates, (underlined in the section discussing silicone implants), the introduction of saline implants to the market stood out as a viable, safer alternative, according to the FDA. There are however certain risks associated with Breast Augmentation that is important for you the patient to be informed of. The most common complications are capsule contracture, hematoma
When breast implants are placed in the body, as well as any other foreign object. The body tends to form a lining around it. This lining is called a capsule and is made out of your own tissue, this capsule is normal and to be expected.
Capsule contracture is the most common complication of breast augmentation surgery. It can happen at any time, but seems more common in the first several months after surgery. At the time of the initial surgery, a pocket is made for the implant. During the healing process, a capsule forms which is comprised of fibrous tissue. Under normal condition, the pocket stays open, allowing the implant to look and feel natural. However in some people, the capsule will tighten, and squeeze the implant. This results in a feeling of hardness, and in a distortion of the way the breast should look.
What causes the capsular contracture?
Germ contamination, infection, seroma, hematoma, and smoking, could all be causes of a capsular contracture. Breast implants placed above the muscle tend to have higher capsular contracture rates, versus breast implants placed behind the muscle (submuscular).
Different grades of capsular contracture
Baker Grade 1- The breast looks and feels soft. It is only when the capsule starts shrinking and contracting further that the capsule contracture occurs. Basically everybody that has breast implants is at this stage.
Baker Grade 2- The breast appears to be a little firm, but still looks natural.
Baker Grade 3- The breast is firm and it starts to look a little distorted in shape.
Baker Grade 4- The breast is hard, and very distorted in shape. The patient is already experiencing pain and discomfort.
How do you treat capsule contracture?
The best, most successful treatment for capsule contracture is an open capsulectomy. In this procedure the surgeon goes in and actually removes the scar capsule. This treatment involves surgery and anesthesia, but is the best way to make sure the capsule is removed in its entirety.
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