What Are the Potential Risks and Complications of Breast Augmentation with Saline and Silicone Breast Implants?
- 1 Bleeding
- 2 Infection
- 3 Seroma
- 4 Pain
- 5 Scarring
- 6 Skin Discoloration/ Swelling
- 7 Sutures
- 8 Delayed Healing
- 9 Alteration in Nipple Sensation
- 10 Implant Displacement and Tissue Stretching
- 11 Asymmetry
- 12 Symastia
- 13 Bottoming Out
- 14 Implant rupture
- 15 Capsular Contracture
- 16 Calcifications
- 17 Silicone Gel Bleed
- 18 Implant Extrusion/ Tissue Necrosis
- 19 Anesthesia
- 20 Damage to Deeper Structures
- 21 Cardiac and Pulmonary Complications
- 22 Breast Disease
- 23 Mammography
- 24 Breast Feeding
- 25 Mondor’s Bands (Cords)
While this is unusual, it is possible to experience a bleeding episode following surgery. If this occurs, emergency treatment to drain accumulated blood, or a blood transfusion, may be required. You can reduce this risk by not taking any aspirin or anti-inflammatory medications for ten days before or after surgery. Non-prescription “herbs” and dietary supplements can also increase the risk of bleeding. The risk of major bleeding, or blood collection, is only about three percent. Most women lose about two test tubes of blood during surgery. Any blood clots that form must be removed in a later surgical procedure.
The risk of wound infection is less than two percent. Most patients receive intravenous antibiotics during surgery and antibiotic medication after surgery, which minimizes this risk. If infections do not respond to antibiotics, the implant may have to be removed, and another one inserted after the infection has healed. . 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. Individuals with an active infection in their body or weakened immune system should not undergo breast augmentation.
Sometimes blood in the depth of the breast tissue can accumulate and form a blood collection, called a Hematoma. Seroma is a fluid that arises from the breakdown of accumulated blood or Hematoma. Seroma and Hematoma can accumulate in the breasts, especially following trauma or vigorous exercise. Additional treatment may be necessary to drain the accumulation of fluid around the breast implants.
All implant patients will experience a degree of pain, as is true of any major surgery. The pain is slightly more pronounced when implants are placed under the muscle. Also, women who have not yet experienced childbirth will probably have a higher degree of pain. Most women report that the pain is greatest in the first 48 hours within surgery. Your cosmetic surgeon will prepare you to address the pain, with a prescription for it prior to your surgery. Prolonged or chronic pain could occur as a result of capsular contraction, nerve entrapment or injury, or even without any specific reason. Removal of implants may not alleviate chronic pain.
The location of a scar depends upon which incision technique is used by your cosmetic surgeon. Patients experience scarring differently – some are more delicate than others, and certain ethnic groups are more prone to scarring. Scars will fade with time, but will always be visible to a degree. Most women accept this as the trade-off for having a fuller and prettier breast.
Skin Discoloration/ Swelling
Some bruising and swelling normally occurs after Breast Augmentation. 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.
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 breast skin or nipple region may not heal normally and may take a long time to heal. Areas of skin or nipple tissue may die. This may require frequent dressing changes or further surgery to remove the non-healed tissue. Individuals who have decreased blood supply to breast 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.
Skin Wrinkling and Rippling
All saline-filled breast implants ripple. Your ability to palpate or even see these skin wrinkles or ripples increased with having very thin skin, very little breast tissue, and when implants are placed over the muscle or in the subglandular pocket. Ripples may be more pronounced in patients who have saline-filled implants with textured surfaces and those who choose extremely large implants. 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. The most common treatment of this is to change from saline to silicone implant which ripples much less.
Alteration in Nipple Sensation
After surgery women can experience reduction in nipple or breast sensation as a result of temporary swelling. After swelling subsides there can be an increase or decrease in nipple sensation. FDA studies of 2000 showed loss of nipple sensation in 8-10% of women at three years and 10% at five years. Hypersensitivity of nipple sensation was reported in five to nine % of women at three3 years and 10% at five years.
In my own practice, approximately five percent of patients lose all feelings in one nipple, 10% lose some feeling, and 85% lose no feelings in their nipples. This has been true however the implants have been inserted.
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.
As is true in nature, no two breasts are identical, even after Breast Augmentation. Some women may require a corrective second surgery if the difference is significant; however it is usually not any more noticeable than when breasts are a somewhat different size in their natural state.
Symastia is when both breasts join each other in a single pocket due to the loss of the cleavage fold. This can happen when the diameter of the two implants is greater than that of the chest, or by excessive thinning out of the skin, or by technical errors during surgery. Fortunately, Symastia occurs very rarely. Unfortunately, its repair is difficult, requiring exchange of implants for smaller ones, and recreation of the cleavage fold with the aid of internal sutures.
Bottoming Out is when the majority of the breast tissue slides below the level of the nipple, making it appear that the nipple is sitting too high on the breast. This can occur in two ways. One cause is due to extreme laxity of the breast tissue when the breast substance itself slides down over the implant and sags below the nipple position. The other circumstance is when the implant migrates inferiorly below the level of the nipple, and even at times below the level of the under-breast fold. This occurs as a result of inadequate support of the implant, either by having it placed over the muscle or by having very loss and inelastic breast tissue. To correct this requires a breast lift procedure and the re-establishment of the under-breast fold.
It is a myth that manipulation of breasts, trauma to the chest, falling off a horse, and having sex cause implants to rupture or deflate. This is rather caused by micro-fractures in the implant wall at areas where is a fold in the implant wall. To reduce this chance, we routinely fill the implants as per manufactures recommendations. Another reason for implant leakage is a faulty valve.
Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients. The same studies showed rupture/deflation rates of 6-9% at 3 years and 8-18% at 5 years for reconstruction patients. The newer implants have a less chance of rupture which is about 5-10% at 10 years. As discussed in the earlier section the implants that we use have manufactures warranty against implant rupture.
According to the FDA, placement of the implant through the belly button (TUBA) and closed Capsulotomy damages the implant and increases their rate of rupture.
Several tests are used to evaluate a patient for the rupture of their implant, including Magnetic Resonance Imaging (MRI), mammogram, and ultrasound.
Sometimes, the degree of scarring around the implant is such that the breast begins to feel hard and in extreme cases painful. It may occur in one side, both sides, or not at all. There are four grades of capsular contracture – Baker grades I through IV.
The Baker grading is as follows:
|Grade I||the breast is normally soft and looks natural|
|Grade II||the breast is a little firm but looks normal|
|Grade III||the breast is firm and looks abnormal|
|Grade IV||the breast is hard, painful, and looks abnormal.|
Capsular Contracture may be more common following infection, hematoma, and seroma. However, it is not known for sure why Capsular Contracture happens. The literature also discusses other factors, such as a textured implant surface and submuscular placement of the implant, which may decrease the capsular contracture rate.
Another surgery may be needed to correct Capsular Contracture, usually for grade III or IV. The surgical procedures range from removal of the implant capsule tissue with or without replacement of the implant itself. Capsular contracture may happen again, even after further surgery.
Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rates of grade III or IV Capsular Contracture of 9% at 3 years and 10-11% at 5 years for augmentation patients. The same studies showed rates of grade III or IV capsular contracture of 25-30% at 3 years and 29-36% at 5 years for reconstruction patients.
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.
Silicone Gel Bleed
Small amounts of silicone gel material seep out through the silicone filled implant shell, and coat the outside of the implant. This material can be felt and seen when a silicone implant is being removed by a surgeon. Scientific studies have shown that this silicone does get into the surrounding lymph nodes and blood stream, but no harm has ever been documented experimentally or clinically.
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.
Whether local or general, all anesthesia involves a risk of complications and injury, including death. This is why choosing a cosmetic surgeon who works with a skilled physician trained in anesthesiology, rather than a nurse anesthetist, is your best choice.
Damage to Deeper Structures
There is the potential for injury to deeper structures including nerves, blood vessels and muscles and lungs (pneumothorax) during this 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.
Cardiac and Pulmonary Complications
ulmonary complications may occur secondarily to both 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. Should any of these complications occur, you may require hospitalization and additional treatment. If you experience shortness of breath, chest pain, or unusual heart beats, you should have this evaluated immediately.
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 to seek professional care should a breast lump be detected. Care must be exercised during breast biopsy procedures to avoid damaging the breast implant.
Breast implants may make mammography more difficult and may obscure the detection of breast cancer. Any breast implant can impair the detection of breast cancer, regardless of the type of implant or where it is placed in relation to the breast. 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. You may be advised to undergo a MRI study in the future to verify the condition of your breast implants inside your body.
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 areola 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.
Mondor’s Bands (Cords)
This condition, named after French surgeon Henri Mondor, occurs when the vein appearing to be a tender cord that runs vertically below the inframammary fold becomes inflamed. This usually corrects itself after a few weeks, and following treatment with warm, moist compresses.
Immune System Diseases
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 saline-filled or silicone gel-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 effect 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.
Summary of Saline Breast Augmentation Complication Rate:
(Source: 2004/ A95 Inamed Study, n=901)
N = 901 Patients
3-Year** Complication Rate
5-Year Complication Rate
|Additional Operation (Re-operation)|
|Implant Replacement/Removal for Any Reason|
|Intense Nipple Sensation*|
|Loss of Nipple Sensation*|
|Intense Skin Sensation*|
|Delayed Wound Healing*|
Note: *These complications were assessed with severity ratings. Only the rates for moderate, severe, or very severe (excludes mild and very mild ratings) are shown in this table.
** As reported in original PMA submission.
Dr. S. Sean Younai, MD, FACS