Breast augmentation has been around since 1962, and both saline and silicone implants were available to women between 1962 and 1992. At that point, the Federal Drug Administration (FDA) placed a moratorium on silicone gel implants, preventing the use of these implants for breast augmentation, because of possible evidence that they caused autoimmune illnesses in women who had received them. Currently, there are two companies in the United States making breast implants: Mentor and McGhan. Currently, both companies are associated with the FDA and have a formal study program to evaluate breast implants. In May 1995, Mentor provided a quick response information service in Santa Barbara, California. They offered information to the public about seventeen major United States and international studies that consistently found no link between implants and autoimmune disease.

In addition, the British government has reviewed the research on implants and has found no evidence of increased risk of connective tissue disease in women with implants. Therefore, they did not change the policy and practice on implants in the United Kingdom. The French government recently lifted its ban on gel implants after reviewing this same research. Although silicone is used in a wide variety of lifesaving devices and technologies, lawsuits from silicone breast implant patients threaten its availability.

The silicone implants currently on the market are more durable than the ones first developed in 1962. The actual capsule itself is thicker and made of solid silicone; the inside of the implant is empty and is usually filled, at the time of surgery, with saline or an antibiotic solution.

Gel implants remain available to patients, but they must be part of an FDA or an FDA–Mentor study and must satisfy specific criteria. There is some speculation, based on recent, overwhelming scientific data, that the FDA may be lifting the moratorium on silicone implants. If so, they would be available to all patients for both reconstructive and cosmetic reasons.

As a practicing plastic surgeon, my thoughts regarding already-placed implants are mixed. Should the breast implants be left in place or removed? Who knows? I have removed implants from patients with autoimmune disease, and their autoimmune disease improved. For others, there was no change. Currently, there have been over twenty-five scientific studies that show no connection between silicone implants and autoimmune disease. Many clinicians who are among the nation's top scientific academicians believe there is no connection between autoimmune disease and saline implants. I therefore believe the various implants are safe, based on current scientific research.

Dr. Joan Campagna, a well-known rheumatologist, is conducting research in this area. The medical community is anxiously awaiting her findings. She currently recommends the placement of saline implants for those interested in breast augmentation. It is true that many medical devices such as heart valves, catheters, and cataract lenses contain Silastic/silicone and do not cause problems for these medical patients.

AUGMENTATION FOR SMALL BREASTS

The most common reason for breast augmentation is to increase the size of small breasts. Patients are either born with small breasts or they lose some breast tissue following breast-feeding, pregnancy, or weight loss. The procedure is relatively easy to perform, and many of these procedures are done each year in the United States and around the world. (See Figs. 12-1 to 12-3.)

AUGMENTATION FOR SMALL BREASTS continued...

The Doctor's Company, a prominent malpractice insurance carrier, has prepared a document which outlines a comprehensive checklist for patients and their plastic surgeons to review and discuss prior to the procedure. I use this form whenever I consult with a patient who wants to undergo breast augmentation. First, I discuss alternative operative procedures. Some older techniques of fat transfer are no longer recommended, because fat grafts can create calcifications that prevent accurate mammographic analysis for breast cancer.

Each plastic surgeon has a unique way of doing the procedure. Usually performed under general anesthesia, it can also be done under IV sedation. At the recommendation of the implant companies, most surgeons place the saline implants underneath the patient's pectoralis major muscle (see Figs. 12-4 and 12-5).

I ask a patient to bring pictures to the initial consultation of what she wants to look like regarding her anticipated outcome and breast size. The idea of "beauty" is personal and varied. The average cup size of a woman who has undergone breast augmentation is approximately a "C" cup. Some women will opt for a "D" or larger, but this needs to be discussed with your plastic surgeon ahead of time. Sometimes, there are constraints on an individual's anatomy, for example, a woman who is very petite would not tolerate a "D" or "DD." The implants would be too large to insert. The most common breast implant size is from 270 to 465 ccs of normal saline.

IF ONE BREAST IS LARGER THAN THE OTHER

Asymmetry (a difference in size between the two breasts) exists in all patients. Sometimes it's a subtle difference; other times, the volume difference is quite obvious. Your plastic surgeon can help correct the discrepancy with implants of different sizes. A complete correction is unlikely if the asymmetry is marked, but breast augmentation using two different sizes of implants can help.

Illustrations by Khosrow Matini, M.D.

LOCATION OF INCISIONS

The most common incision is an inframammary approach, made just underneath the fold of the breast. Another approach involves the circumareolar area: an incision is made just around the lower part of the areola (the darker area of the nipple). A third approach is to place the implants by inserting them at the underarm or axilla area. (See Fig. 12-6.) All incisions heal relatively well. Your surgeon will discuss the appropriate incision for you. Some surgeons are able to use a special endoscope and place breast implants through a small incision in the belly button (umbilicus). Very few surgeons are currently trained in this technique, however.

TYPES OF IMPLANTS AVAILABLE

Saline implants are currently available to all women interested in breast augmentation. If patients who have previously undergone breast augmentation with silicone implants wish to have them replaced, they can, if they are willing to become part of an ongoing FDA–Mentor study. Occasionally, a woman who has had saline implants and is bothered by problems with them can switch over to silicone, depending on whether she satisfies the criteria for the Mentor or McGhan study: thin skin, severe wrinkling, ptosis, or for breast reconstruction. If a patient has undergone a breast augmentation with saline implants and is unhappy with the "feel" of the implant, she may satisfy the criteria of the FDA–Mentor study to have silicone implants instead. Plastic surgeons must fulfill special requirements of the FDA–Mentor and its local hospital IRB (investigation review board) before they are allowed to place silicone implants.

The Saline Breast Implant versus the Silicone Breast Implant

The advantages and disadvantages of saline and silicone implants are always included as part of the discussion during my preoperative consultation:

Saline Implants: Advantages and Disadvantages

• No known connection with autoimmune disease.
• If it ruptures, your body will absorb the saline fluid.
• Occasionally, patients will feel on the side of the implant a "rippling" of the implant. If the implant is under just breast tissue, you may actually see "rippling." A surgeon must overfill the implant by 10 percent to eliminate some of the rippling.
• The feel of the implant may be firm, whereas silicone implants feel more like breast tissue.
• Safe per the FDA's current recommendation.
• Recommended by most rheumatologists as an alternative to silicone augmentation.
• Less incidence of capsulary contracture (scarring around the implant).

Silicone Implants: Advantages and Disadvantages

• Concern for connection with autoimmune diseases.
• If it ruptures, the body will not absorb the silicone.
• Silicone has been found in the local and distant lymph nodes and may travel to other locations and affect us systemically—how it does, at this point, nobody knows.
• Feels more like breast tissue.
• Increased incidence of capsular-scarring contracture.

INHERENT RISKS

The main goal of this procedure and all procedures is to have satisfied patients who are completely happy with their results. As with any operation, there are some inherent risks, however, the main three being bleeding, infection, and scarring specifically related to the implant capsular contraction formation (scarring around the implant).

INHERENT RISKS continued...

Every single person who undergoes augmentation will have a foreign body reaction to the implant. The degree to which this occurs depends on your own individual response and how you heal. Some women develop so much scar tissue that the implants become quite firm. A classification system called Baker's class I, II, III, and IV is used to classify the severity of the reaction.

Baker's class I shows no scar contracture. Class II and class III are differing degrees of scar contracture. Class IV results in significant, painful, noticeable contraction. If a contracture does occur, it can be improved with placement of the implant under the muscle or switching over to saline implants. When the implant is replaced and/or the scar tissue removed, it is only necessary to use the same incision. The final healing of the incision will probably be no different than before. Currently, there's a smooth-walled implant as well as a textured-wall implant. This textured-wall implant tends to decrease the amount of capsulary contracture around the implant because it disorients the collagen bundles.

Ruptured Implants: What Happens, What Can I Do?

Breast implants can't be expected to last forever. There is always a possibility that an implant will rupture. A breast implant can break due to injury to the breast, or through normal wear over time. Some implants deflate or rupture in the first few months postsurgery, some deflate only after several years, and others remain intact ten or more years after surgery. The older the implant, the more likely it is to rupture. If a patient is involved in a ski accident, hits the steering wheel hard, is assaulted, or the breast implant receives a strong blow, there is a strong possibility that the implant will rupture. A routine mammogram can also rupture an implant.

Researchers are presently conducting studies to determine rupture rates over time. Ruptured implants must be removed surgically.

If an implant does rupture, one of the following may happen:

• If it is saline, the breast implant will go flat as a pancake, and the leaked saline from the implant will be absorbed by the body instead of being treated as a foreign material (salt water is naturally present in the body). Some patients develop a fever and rash with the rupture of a saline implant, however.
• If it is silicone, the rupture is harder to detect. The breast may lose its overall shape. There may be distortion or an irregular contour. Sometimes a doctor needs to order a mammogram to detect the rupture of an implant, or an MRI, which is a more specific test, to determine if an implant has ruptured. If implants are twelve to thirteen years old, they are likely to be ruptured, and most surgeons will recommend their removal. Typically, in such situations, patients opt for replacement with a newer type of implant.

Additional Surgeries

Any woman with implants must understand that there is a chance that she will need to have additional surgery in the future to replace or remove a ruptured or worn-out implant. Other problems such as capsullary contracture, infection, shifting, and calcium deposits can create the need for surgical removal of existing implants. You must discuss such risks and additional surgeries with your physician.

Increased Difficulty in Breast Cancer Detection

The most important risk for any breast augmentation patient is the possibility that breast cancer in the future will not be easily detected. The implant can interfere with breast cancer detection during mammography. It can hide suspicious-looking patches of tissue in the breast, making it difficult to interpret results.

To avoid this risk, I recommend breast augmentation be done with the breast implant placed underneath the muscle. This helps to improve the detection of breast cancer if a breast mass develops, and actually improves the ability to see the breast tissue during a mammogram. In my practice, I request that patients obtain a mammogram prior to the procedure if they are thirty-five years old or older, or if there is a family history of breast cancer. This is useful in ascertaining a baseline prior to the procedure. Another mammogram is recommended anywhere from six months to a year following the operation to determine if there are any changes. Usually, extra views and special techniques such as the Ecklund view are used during mammography for patients with breast implants in order to see more breast tissue.

There are rare and unsubstantiated, but possible, relationships of implants with connective tissue disorders such as rheumatoid arthritis, lupus, and scleroderma (see the earlier discussion of this connection).

Future Pregnancy and Nursing

There are many patients with breast augmentation who have successfully breast-fed their children. The operation itself does not affect the milk ducts, so architecturally the operation is theoretically safe. If a patient is interested in breast-feeding after augmentation, there should not be any difficulty. Some women are simply not able to breast-feed, however, and this has nothing to do with breast augmentation.

Complications

Complications are always a possibility, as with any operation, although they are rare. The main ones in this case are infection, bleeding, excess or obvious scars, or changes in nipple sensation. With regard to infection, it's very important that the plastic surgeon place you on antibiotics both during and after the procedure. It's important that you take every single antibiotic dose and not miss any. The implant is a foreign object that is being placed into your body under sterile conditions, but if you are prone to infection, you may develop one. If an infection does occur, your surgeon has to be notified right away. Signs of infection include redness, tenderness, drainage from the wound, fever, and chills.

BREAST IMPLANT REMOVAL AND AUTOIMMUNE DISEASE continued...

As this book goes to press, surgeons are removing fewer and fewer silicone breast implants because the scientific data suggests no sure connection between autoimmune disease and breast implants. For those women who do want to switch, though, silicone implants can be replaced with saline.

Still others have the implants removed but not replaced at all. Some of these patients do quite well; others experience some difficulty accepting the fact that they no longer have the fullness they had with the breast augmentation. Sometimes this loss feels very similar to that of a woman who has undergone a bilateral mastectomy, and there can be significant depression that needs to be worked through.

THE FUTURE IMPLANT

At this point in time, saline implants prevail. As mentioned, they are produced mainly by two United States companies: the Mentor Corporation and the McGhan Corporation. These implants must be filled with saline solution during the actual augmentation operations. In addition, there is a European line called a PIP saline implant, which is also available prefilled.

Silicone breast implants are available to plastic surgery patients as long as these patients have had previous silicone breast implants or as long as these patients fit the criteria for inclusion in what is considered an FDA evaluation study or adjunct study, discussed earlier. Approximately six hundred plastic surgeons who actually have access to the implants and are allowed under federal law to use them are currently reviewing silicone breast implants in the United States.

Table 12-1.

Breast Augmentation

Regarding breast augmentation (see Table 12-1), initial recovery time is four days, and complete recovery time is four to six weeks. Here the risk factor is minimal if the patient is in good health. The pain factor is moderate. Most patients are uncomfortable for the first four days. Surgeon's fees for breast augmentation range anywhere from $3,000 to $4,000. Saline breast implants cost anywhere from $950 to $1,300, and silicone breast implants usually cost about $1,800. Additionally, there are costs for anesthesia fees and the use of the operating room.

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