Breast enlargement (augmentation mammoplasty) is the second most-common cosmetic operation performed in the United States--over 364,000 women requested this operation in 2005, up 9% from 2004, and up 260% from 1997 [American Society for Aesthetic Plastic Surgeons Data]. Breast augmentation has been the most common operation performed at Minneapolis Plastic Surgery for the past four years; every year several hundred patients undergo this outpatient one-hour operation in our office surgical facility.

Some women who choose this procedure do so to restore breast volume lost as a result of pregnancy, breast-feeding, weight loss, or aging. Others request this outpatient operation to improve symmetry in breasts that have never matched in size, and many women simply wish the improvement in self-image or clothing fit that fuller breast size gives them.

 Whatever the reason for requesting information about this operation, you must understand that this operation is appropriate for you if and only if:

• You have realistic expectations regarding potential risks vs. benefits
• (for young women) your breast development is complete
• You have decided to undergo this operation to feel better about yourself, not to live up to the expectations of anyone else.
• You are not pregnant or breast-feeding

A BRIEF HISTORY

The modern era in breast augmentation began with the development and surgical implantation of silicone gel breast implants in a woman in 1963. In the thirty years that followed, plastic surgeons worldwide used silicone gel-filled breast implants for both breast reconstruction and elective breast enlargement in well over 1 million women. Saline-filled breast implants were also used during this time, but in only about 15% of all patients receiving implants.

Breast implants were developed and utilized more than a decade before the FDA began regulating medical devices in 1976; the safe and effective use of silicone in these and other medical products such as pacemaker insulation, lubrication for insulin needles, chemotherapy tubing, and artificial joints was well-established before the FDA could evaluate all of them. Because silicone breast implants and many other silicone medical devices were already in use prior to 1976 when the FDA began regulating them, the ongoing use of these products was “grandfathered” by the FDA without formal evaluation and approval. None of these other silicone medical devices has been made unavailable to patients, but lack of formal FDA evaluation and approval of breast implants came into public awareness in the early 1990's.

The lay media has been responsible for a great deal of information and misinformation regarding breast augmentation in the past decade and a half. Many women remember tabloid and TV talk shows' focus on the supposed problems claimed to be associated with silicone gel implants. Despite a lack of scientific data supporting these concerns, in 1992 the FDA restricted the use of silicone gel breast implants in women requesting elective breast augmentation.

At no point have silicone gel implants ever been “taken off the market,” but until November 2006 their use required enrollment in the FDA study that allowed only eligible patients and plastic surgeons access to them under strict guidelines.

Since the FDA restrictions in 1992, numerous scientific studies (over 30 in the past decade) continue to show NO cause-and-effect relationship between silicone gel breast implants and autoimmune-type illnesses (such as rheumatoid arthritis, lupus, scleroderma, or so-called "human adjuvant" diseases).

Since 1992, silicone gel implants have been used by plastic surgeons (including both Dr. Tholen and Dr. Gervais) involved in FDA-approved studies for patients undergoing breast reconstruction, revision in certain breast augmentation patients, and in those patients with congenital breast deformities or requiring breast lift.

After exhaustive review of the past nearly four decades of use, the FDA approved the use of saline-filled implants in May 2000.

Late in 2003, the FDA reviewed all of the available scientific data about silicone gel implants (including very detailed information from implant patients over the past decade), and heard testimony from patients, physicians, and researchers. The expert physician advisory panel to the FDA voted 9-6 to recommend the FDA approve the use of silicone breast implants for primary elective augmentation. However, the FDA deferred its decision, requesting “additional information” before granting approval.

In spring 2005, the FDA again revisited the request by both implant manufacturers for approval of general use of silicone gel implants; the expert physician advisory panel recommended approval for Mentor Corporation’s gel implants. Late in 2005, Both Mentor and Inamed received letters of “[gel implant] product approvable” from the FDA .

On November 17, 2006 the FDA approved the use of silicone gel implants (from both companies) in patients over the age of 22, with certain restrictions, including inclusion in the FDA study that has been ongoing for the past several years.

Opponents of silicone gel implants continue to claim they cause autoimmune illness or are unsafe, but peer-reviewed scientific studies by many researchers and institutions have shown them to be safe and effective for their intended use. The controversy about gel implants has made them one of the most intensely-studied products in the medical marketplace.

BASIC FACTS

• Breast implants do not increase the risk of developing breast cancer.
• Mammography and breast self-examination can be performed on augmented breasts.
• Augmented breasts both look and feel normal in the majority of women.
• Breast implants do not "get hard," nor do they automatically need replacement after ten years.
• Nipple sensation and the ability to breast-feed are preserved in most patients.
• Breast implants (neither gel nor saline) do not cause or increase the risk of developing arthritis, lupus, scleroderma, or connective tissue diseases.
• Saline implant leakage is uncommon, and can be dealt with when it does occur. Silicone gel implants are “cohesive” and do not leak.
• Silicone gel implants are now available for use in first-time breast augmentation patients over the age of 22.

YOUR CONSULTATION

Any patient considering breast augmentation must have a personal consultation, during which she will discuss her individual cosmetic goals and concerns with Dr. Gervais or Dr. Tholen. A complete medical and surgical history will be obtained, and should include information about allergies to any medications. You must inform your surgeon of all prescription or over-the-counter medications, including herbal, vitamin, nutritional supplements, or appetite suppressants. Some of these can interfere with proper blood clotting and increase the risk of bleeding after surgery--you must avoid aspirin or ibuprofen-containing products, Aleve™, additional vitamin E (the dose in a single daily multivitamin is OK), and any herbal remedies for a full two weeks before and after surgery.

Your pregnancy, breast-feeding, and mammographic history is important, as is physical examination of your breasts, skin and muscle tone, and nipple-areola position. If there is excessive ptosis (sagging of the breast skin) or malposition of the nipple-areola complex, a breast lift (mastopexy) procedure may be necessary. After examination, your surgeon will determine the exact type of breast lift that may be necessary, along with the additional incisions and resultant permanent scars. Other conditions such as nipple inversion, tuberous breasts, significant asymmetry, Poland's syndrome, or changes from prior surgery can be corrected or improved. Augmentation with breast lifting requires additional operating time, incisions, and cost, but will be necessary for women with more breast ptosis (drooping or sagging of the breast skin), or nipple position below the inframammary crease.

THE PROCEDURE

There are four types of incision used for augmentation mammoplasty: axillary (armpit), periareolar (around the areola-the dark skin surrounding the nipple), umbilical (belly button), and inframammary (in the skin crease under the breasts). Each of these choices has pros and cons; some surgeons use some or all of these options, whereas others have a preference based on training, experience, or habit.

The armpit incision is often thought to create a "hidden" scar because the scar is not visible on the breast itself. However, the armpit scar can be visible when the arm is raised with a swimsuit, sleeveless top, or strap-type blouse being worn, and this scar may be widened or more visible than other areas because of its presence in a warm, wet, bacteria-rich environment which is constantly being stretched with every arm movement. In addition, dissection from the armpit incision requires the arm be elevated during surgery, raising the position of the breast, and potentially causing malposition of the implant with relation to the crease. A higher proportion of high nipple, "bottoming-out" augmentations are caused by improper pocket creation with this incision raising the breast during surgery. One final consideration with the axillary incision is that dissection from this vantage point may cause a higher likelihood of nipple sensation loss, since the (lateral fourth intercostal) nerve to the nipple runs along this route on the lateral chest wall.

The periareolar incision is generally done from the three o'clock to nine o'clock position at the junction between the normal breast skin and the darker adjacent areolar skin. Usually, this scar can be minimally visible when healed; however, this scar is visible when unclothed and can occasionally be unsightly, wide, thick or irregular, and can give a sharp line of visibility in an area where the areola color normally undergoes a gradual transition from dark to light. In addition, this incision requires cutting through ducts that end at the nipple, as well as the breast tissue itself, in order to create the implant pocket. This can cause internal breast scarring and/or calcification, which can make mammograms more difficult to read. Since the nerve branches to the nipple area are partially cut by this incision, a somewhat higher likelihood of nipple-areola numbness can occur. Ductal bacteria may also increase the possibility of capsular contracture, so cutting through breast ducts is inadvisable, in our opinion.

The umbilical incision involves use of an endoscope (lighted tube commonly used to perform tubal ligations, appendectomies, gallbladder removal, and visual evaluations of the stomach or colon) to create a pocket beneath the breast or chest muscle for the implant. The creation of the implant pocket is done by blunt dissection with a temporary tissue expander, and bleeding or inframammary crease malposition can require an additional incision on the breast, which negates the main advantage of using the umbilical approach (no visible breast scar). Very few plastic surgeons utilize this incision for breast augmentation, and the learning curve is difficult, but acceptable results have been shown by reputable, board-certified plastic surgeons, so consideration of all options is reasonable. Silicone gel implants cannot be placed via this incision.

The inframammary incision (beneath the breast in the crease) is the most common one used for breast augmentation. We believe this incision provides the best exposure to create an implant pocket with the least amount of bleeding (and the highest likelihood of controlling this bleeding should it occur), avoids the course of the nerve to the nipple in most cases, does not cut through breast tissue and/or ducts (avoiding the mammographic concerns), and leaves a short scar that is not visible clothed or unclothed unless one lifts the breast or looks from beneath. When reclining, the breast falls to the side and up, and the crease (inframammary) scar can be visible; in most cases it is nearly imperceptible. Both plastic surgeons use dissolving stitches beneath the skin surface: no cross-hatch or railroad-type marks, no sutures to be removed, and just a thin-line scar hidden in the natural inframammary crease.

CHOICE OF IMPLANT

Breast implants come in numerous sizes, configurations, surface characteristics, and fill material. Saline identical to intravenous fluid was the most common type of filler material used in the United States from 1992 to November 2006, when the FDA approved the use of silicone gel-filled implants. Prior to the 1992 FDA action, silicone gel implants were utilized in over 85% of all breast augmentations in this country, and remain the most commonly used implant worldwide. Other types of filler material have been evaluated over the years, and one or more problems are associated with these. For instance, several years ago, soybean oil-filled implants were studied extensively, and were used in many patients in Europe, as well as a few US patients in FDA studies. Breakdown of the oil, rancid smell, and other concerns ultimately led to withdrawal of this implant (Trilucent™) in the US and in Europe. Fat as implant fill material has the same concern, and is not done. Fat graft injections of a patient's own liposuction fat (directly into or beneath the breasts) have been proposed by some physicians. The American College of Surgeons and the American Society of Plastic Surgeons condemn this procedure because it can cause microcalcifications within the breast and interfere with the mammographic detection of breast cancer. A recent study confirms that fat cells removed via liposuction are mostly destroyed and non-living; freezing the fat kills even more cells (ice crystals puncturing cell walls kill the fat cells), so this is worthless and potentially harmful.

Other implant materials are being studied, including a more firm, shaped cohesive silicone gel (the “gummy-bear” implant). This study implant retains its form and innate intactness even when its outer shell is punctured. This implant is more firm (like a “gummy bear” or silicone bathtub seal) than the softer “standard” silicone gel implant, and requires a larger (2½ inch) incision for placement. However, the “standard” silicone gel implants presently used (as part of the more general FDA study since 1992) are softer but also cohesive, and do not leak if the shell is cut or punctured. These silicone gel implants can be inserted via a 1½ inch incision. Cutting either of these types of implants is like cutting Jello—you get two intact parts but leakage does not occur.

With silicone gel implants, microscopic gel molecules can still enter a patient's body, just as liquid silicone does in the patient who has an injection with a needle lubricated with liquid silicone. No scientific study to date has provided credible evidence that silicone has any cause-and-effect relationship with autoimmune diseases or conditions such as rheumatoid arthritis, lupus, scleroderma, or so-called "human adjuvant illnesses." With these studies in mind, silicone gel implants were FDA-approved in November, 2006 for elective first-time cosmetic breast augmentation in this country, in women over the age of 22.

The surface of breast implants can be smooth or textured, and the filler material silicone gel or saline. When gel implants were used prior to the FDA restrictions of 1992, placement above the muscle was also the preferred implant position for many plastic surgeons. Texturing the surface of the gel implant reduced the incidence of capsular contracture in this position (above the muscle and just below the breast). However, after the FDA restriction on gel implants and switch to saline-filled implants, placement above the muscle led to unacceptable wrinkling that could sometimes be felt or seen. This led to most surgeons switching to placement of saline implants below the muscle to increase tissue coverage and reduce these concerns. Even placement of saline-filled implants below the muscle will not always eliminate feeling or seeing implant wrinkles or ripples, particularly in thin patients and/or patients with very small overlying breast tissue. Now that silicone gel implants are again available, more patients will be able to avoid the “water-balloon” feel and visible or palpable rippling seen in some saline implant patients.

Using textured implants below the muscle can cause unnatural adherence to the chest, and restricted natural movement of the breast. In addition, the lack of gel to act as a lubricant inside the implant (saline is a poor lubricant) can allow flexing and creasing of the implant shell surface with each movement or breath of the patient, ultimately leading to a higher risk of failure at one of the low spots in the textured surface, with leakage and deflation of saline implants. The textured implant shell is also thicker, and more palpable. Submuscular placement already reduces the incidence of capsular contracture, so smooth implants in this location are preferable to adherent textured-surface implants. The smooth-shell saline-filled implant is softer, less palpable, less likely to deflate (if properly filled), and has low capsular contracture formation. It also moves with the patient's position, and is therefore more natural and breast-like.

However, smooth-shell silicone gel-filled implants are even more homogeneous with breast tissue, and provide the softest, most breast-like, and natural “feel” of any implant.

Implant shape is another frequent question. The so-called "anatomic" or teardrop-shaped implant has a textured surface and a sloped upper pole with fuller lower pole projection. It has been suggested that this implant has a more natural look than the round implant, and much advertising and marketing has been done to promote this implant to the public. The implant is a good device, but it is more expensive than the smooth, round implant, and whether or not it is truly more "anatomic" is questionable. A recent study has been done comparing actual women with smooth, round implants to women with textured, teardrop-shaped implants. Mammograms were performed in upright and supine (lying-down) positions, and digital tracings computerized and compared. Both the round and teardrop-shaped implants had a sloped, teardrop shape when women were upright. In fact, the two types of implant were indistinguishable on X-ray. But in the supine (lying-down) position, the natural non-augmented breast flattens, drops to the side of the chest, and assumes a round shape, as does the round smooth implant. The teardrop-shaped implant stays teardrop-shaped in the lying-down position, which makes this actually less anatomic than the round implant! Still, in rare situations, the textured or teardrop-shaped implant may be an appropriate choice.

CAPSULAR CONTRACTURE

Breast implants do not become hard, ever.

When an augmentation patient has abnormally hard breasts, the problem is the scar capsule around the implants—for one reason or another, the capsule has thickened and contracted, squeezing the implant into a smaller space and causing the hard “feel.” The human body creates a scar around any kind of foreign body, whether it is a pacemaker, a breast implant, or an artificial hip. Since every person forms scar tissue around any foreign body, every woman undergoing breast augmentation will have a capsule, but fortunately, only a few will develop capsular contracture to a degree that is problematic. If the scar capsule is thin, soft, and pliable around a breast implant, the augmented breast will feel soft. Since all scar tissue contracts, an excessively thick, nonpliable, and contracted scar capsule around a breast implant can make an augmented breast feel hard. Capsular contracture can be mild (Baker grade 1) or severe and visibly deforming (Baker grade 4).

Many studies have been done over the years regarding capsular contracture, and how to control or minimize the likelihood it will occur. With a surface skin cut or surgical incision, despite any surgeon's skill, best efforts, and technique, some patients will heal with a thick, wide, or ugly scar. This occurs rarely, and is slightly more common in dark-skinned races. Vitamin E massage, scar pads, steroid tape or injections, or even scar revision plus any or all of the above can be done to reduce visible surface scars. Radiation treatments have even been used for the most severe surface scars, known as keloids. Fortunately, these are uncommon.

Similarly, internal scar contracture causing firmness or distortion of appearance is also uncommon, occurring in 5-10% of augmentation mammoplasty patients. If this occurs, surgical revision may be necessary, and may in some cases recur despite careful reoperation.

Avoidance of most cases of capsular contracture is possible, in our opinion, by careful initial surgery. Any foreign body, such as talcum powder from the surgeon's gloves, cotton fibers from surgical sponges, dust or bacteria from the air of the operating room on the surface of the implant, bacteria from the ducts of the breast, and post-operative bleeding or bruising all can cause an increase in scar formation. This is analogous to a grain of sand in an oyster; in humans, a pearl is not formed, just layers of scar tissue, in response to one or several of these irritants. Every effort is taken to reduce these to an absolute minimum in order to reduce the likelihood of capsular contracture. Both surgeons utilize a minimal-touch, closed system to place and fill the implants, as well as antiseptic irrigation, pinpoint cautery control of capillary bleeding, and avoid sponges in the pocket (or irrigate after use, if needed). Neither surgeon uses drains for breast augmentation. Drains may allow blood or fluid out of the pocket, but of greater concern is that they can allow bacteria in, increasing the risk of contracture or infection severe enough to require implant removal. Careful surgery and control of all bleeding points is preferable to a drain, or a tight surgical bra or elastic wrap after surgery! Intravenous antibiotics are used prior to surgery, and oral antibiotics are continued for several days postoperatively.

As stated earlier, textured saline implants have been shown to have a somewhat higher leak or rupture rate than smooth saline implants. However, even smooth implants can leak or deflate, particularly if they are underfilled. Underfilled implants can develop wrinkles or creases that flex and bend with each movement or breath, and eventually a tiny pinhole can develop to cause leakage or deflation. Proper saline implant fill volumes have been shown to be higher than the label on the manufacturer's box; a 300cc implant filled to 300cc has a higher likelihood of leakage than a 300cc implant filled to 340cc, which is closer to the optimal fill volume. Several studies have confirmed the validity of proper “over”filling; each type of implant has its own optimal overfill volume which your plastic surgeon will then adjust according to your own anatomy and needs. Nationwide 5-year leak rates have ranged from 6.8 - 9.7%; our own leak rates are substantially lower at 2-3%. If leakage or deflation occurs, a simple operation (easily done under local anesthesia if you wish) to open the incision, remove the old implant, and place a new one can be performed without the discomfort or recovery of your initial operation. The cost of the new implant is covered by the manufacturer.

Of course, if you choose silicone gel implants, there is no intraoperative filling, as the implants come completely filled, sealed, and in many different size gradations directly from the manufacturer. Even if the outer shell of the implant were to be damaged or opened, the silicone gel within the implant is cohesive and non-liquid in nature, and cannot “leak” out.

RECOVERY

After an hour or so in the recovery room, you will be discharged to the care of another adult who needs to stay with you for the evening. You will need someone to bring you to your first postoperative recheck, since you should not drive a car for the first two days after surgery, or while taking pain medication.

 RESULTS

Your final appearance will take some time to be achieved, as your muscle, breast tissue, and skin must heal, stretch, soften, and settle over time. Some patients look fabulous days after surgery; others (most) take somewhat longer! You will be sent home in most cases with a Velcro bandeau placed on the upper part of your breasts. This will be worn at night, and in most cases, patients will be asked to remain braless during the day. This will allow your implants to drop into the proper position over time. This time is different for each patient. Do not judge your recovery by the yardstick of a friend's or relative's experience; every patient is unique, and every recovery and result is also unique. Your surgeon will guide you as time goes by, and advise you on how to enhance your result. We offer our patients a lifetime of "no-charge" rechecks, and will keep you apprised of the best advice we are capable of.

Most patients look good in clothing within days after surgery; unclothed, a soft, natural appearance will take longer. Final softening, settling, and sensation return can take several months to as long as a year or so. During this time, or at least as long as your scars are pink, you must avoid tanning booths or any source of ultraviolet exposure in order to reduce the chance of permanently darkening the scars. Vitamin E oil or ointment massage of the scars after three week' time can help to soften and fade them; you should not begin this prior to three weeks after surgery to reduce the tendency to prematurely soften and stretch the scars. If you have a tendency to form thick or heavy scars, your surgeon may instruct you in the use of scar pads or other scar-treatment remedies as other ways of helping to reduce this concern.

All in all, augmentation mammoplasty is a straightforward procedure with a very high satisfaction rate. This information and these recommendations are not intended to be complete or all-inclusive. Postoperative rechecks are designed to monitor your progress and address any specific concerns or questions. Following the guidelines above will help you to achieve the best result that we are capable of obtaining for you.

QUESTIONS

Please feel free to ask questions at any time.

For more information, or to schedule a complimentary consultation with our plastic surgeons, please call: 763-545-0443.

Copyright: Richard H. Tholen, M.D. and Douglas L. Gervais, M.D., 2007