Surgical procedure

Surgery for insertion of the devices can be performed under local or general anesthesia and is usually an outpatient procedure. The incision for cosmetic insertion most commonly is made along the lower edge of the areola, in the axilla, or in the inframammary fold. For postmastectomy reconstruction, the existing surgical scar usually is used for access. A generous pocket is made for the implant in a plane either deep to the breast on the pectoral fascia (submammary) or beneath the pectoralis major and/or serratus fascia (submuscular). The implant is then inserted and the incision closed.

Safety, Adverse Effects, and Complications

All of the normal risks of surgery and anesthesia can occur with breast augmentation or reconstruction. Infection, bleeding, change in nipple sensation, malposition (hyposensitivity, hypersensitivity), poor healing, anesthetic accidents, and other complications can occur at a rate that is similar to that in any clean surgery in this area on healthy patients. Concerns specific to the breast implant follow.

Repeat surgery

Most women who have implants achieve satisfactory results from one operation, and the implants remain indefinitely without difficulty. As many as 20% of women may need repeat surgery (often more than once). Reoperation may be required for a host of reasons, and for a few women, these devices become high-maintenance items. To place this in perspective, do not expect more from an implant than from any natural body tissue or organ. These devices can be thought of as new body parts and, like our own organs, they may last a lifetime or cause frequent difficulty throughout life.

Capsular contracture

Often referred to as a complication, this phenomenon best is considered an adverse effect. It is the result of the normal process of scar formation resulting from the repair of separation of tissue. One would not consider the skin scar a complication of a cut despite the spectrum of final appearances. Shrinkage or shortening of a scar is a poorly understood phenomenon that varies dramatically among individuals and at different locations and directions on the same person. Contracture around an implant is probably an aborted attempt at extrusion of a foreign body. In truth, the mystery is why contracture does not occur in everyone.

Contracture is the most common adverse effect of breast implants. To achieve a soft, natural-feeling result, the surgical pocket is made somewhat larger than the implant. Normal wound healing forms a scar lining on the pocket surface termed the capsule, which, under ideal circumstances, retains its original dimensions. The oversized pocket permits full flexibility of the implant, often resulting in a breast so soft that the implant is not palpable and closely mimics normal breast mobility and softness.

For reasons that are unclear and appear to be related to a particular woman’s individual biology, the scar envelope sometimes shrinks and squeezes the implant, producing varying degrees of firmness. This commonly is graded on a scale devised by Baker, as follows:

• Grade I - None: The augmented breast feels as soft as an unoperated breast.
• Grade II - Minimal: The breast is less soft; the implant can be palpated but is not visible.
• Grade III - Moderate: The breast is firmer; the implant is felt easily, and its presence is visible.
• Grade IV - Severe: The implant is firm and often tender, painful, cool, and distorted; its presence is obvious.

Contracture can occur soon after surgery or many years later and may be symmetric, asymmetric, or unilateral. Current theory suggests that low-grade contamination by Staphylococcus epidermidis may be the initiating factor of the contracture, but this is not confirmed.

Capsular contracture is not, in itself, a health risk other than its possible interference with mammography or the risk of surgical correction, if required. However, contractures detract from the quality of the results, with the severity of concern depending upon the individual patient. The best results achieve the ideal of a breast so soft that the implant is undetectable. Yet many women prefer a slightly firm bosom while for others even a severe contracture is only a minor nuisance.

The amount of overlying breast tissue as padding influences both the sense of softness and the appearance. If the tissues are tight, usually the breast has a superior fullness similar to the effect of a push-up bra. The most severe degree of contracture may be unaesthetic or deformed, quite uncomfortable, or chronically painful.

The recent innovation of texturing the implant shell initially showed promise of reducing the incidence of contracture. However, recent data from both US manufacturers have been confusing but suggest that little or no difference exists for saline implants. In contrast, the most recent information concerning gel implants demonstrates statistically less contracture in cosmetic patients (smooth 15%; textured 9%; P <0.01) with the textured variety but does not seem to make any difference in reconstruction (smooth 13%; textured 12%).

An undesirable adverse effect of texturing is an unpleasant rippling of the breast surface, especially if little overlying tissue padding is present, such as in reconstruction of very small breasts. This may be visible and unsightly or just palpable and annoying, depending on the thickness of normal breast tissue and subcutaneous fat available to mask the irregularities. For most women, firmness is a more acceptable compromise than rippling, especially if it is in the cleavage area.

Carcinogenesis

No evidence exists that the silicone used in breast implants is carcinogenic in humans. More than 7 epidemiologic studies confirm this, at least for the 10- to 30-year periods covered by these reports. Three recent large-scale studies and 2 smaller ones have demonstrated that women with implants may have up to 30% less breast cancer than expected statistically when matched with the general population.

Three animal studies show the same protective effect, and one preliminary report suggests that blood from women with implants kills breast cancer cells in tissue culture. Therefore, all evidence suggests that at least for the greater than 30-year time frame that silicone implants have been available, the risk of humans developing cancer from silicone breast implants is negligible, if not nil. Recent studies also demonstrate that 5-year survival rates are not affected by the presence of these devices.

A recent study from the National Institutes of Health (NIH) demonstrated the development of myelomas in susceptible strains of rats injected with gel in their peritoneal cavities. This was not observed with oil or elastomer. Eighteen cases are now in a newly established registry at NIH. They are clustered in Los Angeles, Arkansas, and Florida (no new cases have been added since the first 18 were collected 4 y ago).

Monoclonal gammopathy of undetermined significance (MGUS) is found in the serum as a monoclonal immunoglobulin G or immunoglobulin A in 1.5% of the otherwise healthy population. This is believed to have some predictive value in determining the risk of myeloma, since 16% of those with elevated levels develop the disease within 30 years (0.8%/y). A small sample of women with implants has demonstrated an elevated MGUS fraction. However, a search through 4 registries containing more than 20,000 women with more than 120,000 years of risk located only 1 case of myeloma. This information should be considered and studied further, but the evidence is too sketchy to generate alarm. A statistical truism is that “an association does not imply a cause-and-effect relationship.”

Polyurethane-coated implants

The polyurethane coat that covered some implants in the United States before 1991 is known to slowly hydrolyze over several years into unknown breakdown products. Of concern is one constituent of the polymer, 2, 4, toluene diamine (TDA). In studies performed in the 1960s, large doses of TDA fed to highly cancer-prone rats produced hepatomas. When viewed in the light of more modern understanding, the validity of these early experiments is questionable.

TDA never has been documented to be a human carcinogen, but because of this animal evidence, current law, known as the Delaney clause, requires that it be banned by the FDA for use in foods, cosmetics, and implantable devices. (Congress has recently amended this clause to make it more pertinent to scientific reality.) However, no evidence exists that TDA is formed in vivo from polyurethane. While TDA is a building block of polyurethane, it is not produced by hydrolysis, since the molecule is cleaved at the urea fraction rather than at the TDA site. An FDA advisory panel hearing held in July 1991 concluded that the probable cancer risk from polyurethane-coated implants is considered negligible (<1 in 1,000,000).

More recent studies have demonstrated that approximately 80% of women with these devices show traces of TDA in their urine. Traces of TDA also were found in the urine of 11% of the control group, suggesting an environmental source of the chemical. None was found in the blood of patients or controls. Again, the risk of cancer from polyurethane implants was calculated to be less than 1 in 1 million. To date, no cases have been reported in the medical literature of cancer in a woman with polyurethane implants. Because the small but real risks associated with removal are greater than the risk of cancer, the FDA has advised that there is no health related reason that requires removal of these particular devices in asymptomatic women.

CONTINUED ON NEXT BLOG PART 4 HISTORY OF BREAST IMPLANTS

After a long history in breast implants and removal of the silicone breast
implant in 1992, the FDA on November 17, 2006 approved Allergan and Mentor
to again market their silicone breasts implants for primary breast
augmentation in the US. These breast implants differ from the older silicone
breast implants due to the more “cohesive” nature of the silicone, their
outer shell, as well as the styles (shapes) of implants available. Long term
studies were performed on the silicone implants to ensure their safety
leading to their reemergence on the market and ongoing studies currently are
required of the implant manufacturers to ensure the continued long term
safety of the implants.

The newest trends emerging on breast implants center on the development of
cohesive, highly cohesive and form stable gel silicone implants that have
been affectionately termed “gummy bear” implants. These are not widely yet
available in the US, but have been available in Europe since 1994 and in
Canada since 2000 through a special trial program and have been approved for
wide spread use since October 2006. Trials on these implants were also
conducted in the United States and the data are currently being accessed.

Personally, the biggest news on breast implants is the reemergence of
silicone breast implants since November of 2006. They are extremely safe,
more reliable, and in my opinion age better than the saline implants that
there is less “rippling” and palpability in the long term.

You should understand that once you undergo your first breast augmentation surgery
which IS extremely safe, you will be obligated to a few more surgeries of
implant exchange at 10-25 years from the time of breast enhancement. This of
course depends on if the patient becomes pregnant, gains or loses weight and
on the natural aging process of the breast. More importantly, the general
public should understand that the majority of woman who undergo breast
augmentation do not merely desire big breasts, but are inherently
dissatisfied with the shape and perhaps the asymmetry of their breasts and
they desire a more proportionate, shapelier, AND also a slightly larger
volume breast.

Safety

Silicone is probably the most studied implantable material available today. After over 35 well-conducted studies from many countries, it seems certain that this material does not cause disease. The results of more than 7 long-term follow-up studies show that women with implants have a reduced incidence of breast cancer than is otherwise expected in the general population. No hard evidence reveals that a broken implant is harmful. Almost all of the problems that can occur with breast implants, such as infection, hardening, extrusion, and malposition are related to the surgical procedure or the patient’s own biology, not the device.

Benefits and Contraindications

Benefits

Many social subsets of women with various motivations seek this device, especially for cosmetic purposes. However, the prototypical recipient is in her early 30s and is secure and successful in most of her activities, except for this single focus of concern. She is fully aware of the unique ambivalence that society and often family and friends have to an artificial bosom (ie, that breasts are sexy and attractive if natural but somehow frivolous and vain if sought through surgery).

Thus, in contrast to the common cliche, these women seek augmentation despite, rather than because of, social pressures. The depth of this personal need and the importance of this procedure to their sense of wholeness and self-esteem are difficult for even their loved ones and their personal physicians to appreciate. Only the woman and perhaps the plastic surgeon who hears these stories over and over again can understand the power of this need and the significant enhancement of quality of life that these devices provide.

Several surveys consistently have demonstrated that 90-95% of women who have undergone cosmetic augmentations are pleased that they did so, even if the results were less than ideal or were accompanied by complications. At the height of the negative media information in 1991, a survey of 300 plastic surgeons revealed that approximately 3% of these women made inquiries about removal due to concern over safety. Less than one half followed through, which is a measure of the great value of this operation.

This estimate is similar to the percentage of women who took advantage of the implant manufacturers’ offer of financial support for implant removal or replacement. Plastic surgeons suspected that the number of requests for removal of gel devices, usually with saline replacement, increased commensurately with the publicity over the multibillion-dollar class action settlement.

The desire of most women to replace their implants with saline (76% according to a recent study by Spear and Bowen) reflects their satisfaction with the enlargement. More recently, as reassuring research on safety has become available, interest in removal appears to have fallen significantly. Current estimates suggest that 85% of removed implants are replaced. A 1998 attempt to study explantation prospectively failed for lack of candidates. Some women, having experienced both gel and saline, are requesting a return to the gel as they felt that it provided a superior result.

More implants are sold on either coast, suggesting the existence of regional differences in body image. This becomes moot when one realizes that women in the Midwest buy larger bras on average than those that are sold on the coasts.

The anxiety generated by the 1990s media scare and dramatic litigation awards has diminished the significant psychological benefit that accrues from implants. This concern seems to be diminishing; as noted below, the number of cosmetic augmentations now appears to exceed premoratorium estimates following the significant dip of the early and mid-1990s. Therefore, all caring physicians must share the truth with their implant patients and reassure those who have chosen to accept whatever risk may be present.

Table 1. Annual Implant Sales by Pairs*
Open table in new window

*1990-1996 figures represent manufacturer’s estimates for all implant sales, including augmentation, reconstruction, and replacement. American Society of Plastic Surgeons (ASPS) and American Society for Aesthetic Plastic Surgery (ASAPS) data represent separately collected and analyzed membership statistics on cosmetic augmentation using different methodologies. These do not include patients of nonmembers, which is substantial. All numbers are approximations.

Contraindications

Aside from the usual medical conditions that would increase the risk of anesthesia, surgery and/or infection, the most significant red flag, as in all cosmetic surgery, is an unrealistic expectation. Women who are emotionally unstable or are requesting the surgery to please another person should be discouraged from undergoing the procedure. However, this should not be considered a blanket contraindication.

Each patient must be individually evaluated and a decision made as to whether the procedure will enhance the quality of her life, her sense of self, and her sense of well-being. Plastic surgeons must develop the skills to evaluate these intangibles and take the time for a proper evaluation. Because it is so subjective, do not expect 100% accuracy in predicting the outcome; guessing correctly 95% of the time is the best that can be expected.

Silicon, Silica, Silicate, and Silicone

Glossary of terms

• Silicon: Silicon is a metal in the same column as carbon in the periodic table. It is the most abundant element on earth and does not occur naturally in its pure metallic state.
• Silica: Silica in its crystalline form is common sand, marble, or quartz. It also occurs in an amorphous form. Very fine, extremely pure, amorphous silica is used as a filler to strengthen solid silicone, such as in the shell of an implant. Each grain of silica is encapsulated tightly in silicone so that even when the elastomer is abraded or torn, no silica is exposed to the body.
• Silicate: In one form, its hydroscopic properties are used to keep the contents of containers dry.
• Silicone: Substances known as silicones are polymers of silicon and oxygen. Silicone has as many forms as its carbon-based sister, oil. Like salad oils versus motor oils, not all are fit for human consumption. Dimethylsiloxane is the building block for most medical-grade silicone products, including breast implants. It can be made extremely pure and modified into products with a multitude of characteristics (see Image 1 below).

  

  The molecular structure of silicone.

Implant characteristics

Keep in mind the difference between elemental silicon and the polymer silicone. Medical-grade silicone is usually a specific, very pure polymer of silicon and oxygen with methyl side groups (dimethylsiloxane). It is one of the least bioreactive materials available for use in medical devices. The shell is made of a rubberlike membrane of fully polymerized silicone with an amorphous (noncrystalline) silica filler added for strength.

Until the moratorium, most implants used were filled with a silicone gel, the physical form of which can be likened to a spongelike matrix or 3-dimensional net filled with various chain-length silicone oils. These form a physical chemical bond resulting in a gel. The shell membrane is slightly permeable to the oils.

Depending upon the brand, age, characteristics, and environmental mechanics of a particular device, small amounts of the oil diffuse or bleed through the shell. For most implants, this is a matter of a few grams. Newer barrier coat devices introduced in the early 1980s bleed at as little as one tenth the rate of the older materials.

This leakage of silicone should be viewed in perspective. Medical-grade silicone is ubiquitous in the environment, and probably everyone in the civilized world has some form of silicone in his or her body. For example, every disposable needle and syringe, as well as intravenous tubing, is lubricated with silicone. (The FDA permits up to 1 mg/cm² of barrel surface.)

Medications in stoppered vials contain residual silicone from its use in the manufacturing process. Silicone is hydrophobic and lipophilic; thus, various amounts may be injected along with the medication depending upon the lipid characteristics of the drug used. Because insulin binds to silicone, extrapolative calculations suggest that patients with type I diabetes may inject as much as 25-30 g of silicone over a lifetime.

In its solid form, silicone elastomers are used for pacemaker coatings, tubing, prosthetic joints, hydrocephalus shunts, penile implants, and as the envelope for Norplant and other implanted drug delivery systems. Some testicular and chin implants are similar to breast implants, since both usually are made of a silicone gel in a silicone envelope.

More than 1000 medical products contain silicone as either a component or as a residuum from use in the manufacturing process. Silicone is a nonspecific term for a class of compounds, some of which are highly reactive or toxic. The generic term silicone is similar to the generic term oil, which can include both salad oil and motor oil. Within the subclass of medical-grade material, the formulations vary to some degree with intended use. The body may react differently to some of these formulations.

The designation methicone (as in simethicone or dimethicone) as an ingredient in any medication is simply silicone formulated to comply with FDA regulations for human consumption in items such as medication, foods, and cosmetics. Calcium carbonate, magnesia, simethicone antacid (Di-Gel), and oral simethicone (Mylicon) are examples of medications containing silicone that are marketed over the counter, even in pediatric formulations, with FDA approval. Silicones are used in lipstick, hairspray, food processing, skin creams, and cosmetics and are known to be absorbed through both the bowel and the lungs.

Biologically, medical-grade silicones invoke a straightforward, nonspecific foreign body response, resulting in typical macrophage invasion, giant cell formation, and eventual scarring. Several animal studies suggest that relatively huge volumes of gel injected into the peritoneal cavity of rodents may stimulate an immune response. This is not observed with the oil or solid elastomers. It can be demonstrated only by emulsifying the gel, a condition not seen in the implant. Intact gel does not lend itself to these test procedures.

Despite the many reports in the media, exhaustive evaluations by multiple prestigious scientific bodies such as the Institute of Medicine, the British Ministry of Health, the Spanish Government, a committee of the European Union (EQUAM), Harvard University, the Mayo Clinic, and multiple panels of experts established by various courts have confirmed that no evidence exists of any known or new systemic illness definitively attributed to silicones.

CONTINUED ON NEXT BLOG ON THE HISTORY OF BREAST IMPLANTS PART 3

DR MICHELE KOO, MD, FACS, BOARD CERTIFIED PLASTIC SURGEON, ST LOUIS, MISSOURI 314-984-8331

Most of my patients by the time they call and make an appointment for a breast augmentation consultation have been considering this surgery since their teenage years.

Breast augmentations are very safe and have been performed on woman for 40 plus years. Silicone breast implants are again FDA approved for elective breast enlargements for women 22 years of age and older.

Saline breast implants have always been available for cosmetic breast enlargements and continue to be used safely.

Breast enlargements with breast implants do not necessarily mean that you will be “gi-normous” or that your breasts will be in a different zip code from your body. What it means is that you will be more proportionate for your body and you will feel sexier and more in balance for your height, weight, shoulder and hip circumference. When you are naked or in a swim suit, you will feel more confident and more sexy and in balance. It is about feeling better about your body and being less self conscience not necessarily having breasts that poke out your friends eyes.

I perform the breast enlargement surgery under general anesthesia as an outpatient and the surgery itself takes just under one hour. You will be slightly tired for a few hours after the surgery from the anesthesia but you will have very little pain. You won’t like the tight surgical bra but you must leave the compressive surgical bra on day and night for the first 4 days. You will be allowed to take the bra off and shower after 4 days.

You will return to light cardio activity at 2 weeks and full activity at 4 weeks.

Breast enhancement surgery is safe with minimal recovery. You should not feel that it is only for the wealthy. Breast augmentation with saline or silicone implants is very affordable and we work with a financing company that specializes in cosmetic procedures.

I am extremely honest and straightforward with you about the correct type of breast implant that is best for you depending on your type of original breasts as well as the breasts you want to ultimately have. I will also guide you on your choice of size and style of breast implant that will give you the most natural sexy breasts that are not at all conspicuous and overwhelming for your body. I completely understand woman’s goals of looking sexy but natural with their breasts, that you don’t necessarily want your sexy new breasts to be the center of attention of your body.

DR MICHELE KOO, MD, FACS, BOARD CERTIFIED PLASTIC SURGEON, ST LOUIS, MO 314-984-8331

Before Breast Augmentation

After Breast Augmentation

There are many different sizes and shapes of silicone and saline breast implants which are very safe that can give you very natural looking breasts. You can be pretty much any size you want to be with breast augmentation.

Dr Koo will show you many many before and after pictures of women who have had the same procedure that have breasts that resemble yours. She will also show you pictures of women who have similar height and weight as you to give you a better idea of the shape and size you might want for yourself.  Dr Koo will spend as much time with you as you want to determine what is the perfect breast implant size and shape is for you and whether you should have the breast implant placed under the muscle or breast tissue. These choices are determined by the shape of your breasts, how much breast tissue you have, how low or high you want your breasts and the incision she chooses for your breast augmentation.

She will be able to create the sexiest yet most natural looking and feeling breasts for you with the perfect breast implant for your body.

The first thing you should know about breast augmentation is that this will not be your last surgery. You will need to plan for at least 2 or 3 more surgeries in your lifetime depending on your age at the time of your first breast augmentation. Your breast implants will last approximately 20 years whether it is silicone or saline. Dr Koo recommends that you change the silicone implant at about the 20 year mark or when there is a change in the way the breast implants feel or look.

If your saline breast implants rupture, you will notice a change in size within 3-5 days of the rupture. The saline will be absorbed by your body and the ruptured side will be smaller than the breast that has not ruptured. You should then have BOTH breast implants changed and start at time zero with both breasts.

If you have silicone breast implants, you may not have to change your implants until there is a change in the way your breasts look or feel. Dr Koo’s recommendation is to change the breast implants at approximately 20 years or before if there is a problem. If, however, you are not having any problems, you can wait until there is some change.

Mammograms are recommended yearly starting at age 40. If you have a family history of breast cancer you might need a mammogram as early as age 30 or 35 depending on your breast examination. Dr Koo always follows her patients on a yearly basis without further charge and encourages women to see her every year to teach them how to examine their breasts and to educate them as to how their breasts feel with implants in place.

Dr Koo places the implants over and under the muscle and decides which is the perfect position for you depending on how much breast tissue you have, where your breasts fall in relation to the inframammary crease, and your desire to have higher or lower breasts. There are many many subtleties of breast augmentation and the type and placement of the breast implants that Dr Koo will determine for you and guide you for creating the perfect, sexy natural breasts that can be created with breast implants.

Call Dr Michele Koo, MD, FACS, Board Certified Plastic Surgeon, St Louis, Missouri for the most natural looking and feeling breast implanted breasts possible. She will take care of you throughout the years.

For more information about breast feeding and breast implants and the need for breast lifts after children and as the breasts age with implants in place, see the next blog coming up.

DR MICHELE KOO, MD, FACS, ST LOUIS, MISSOURI, 314-984-8331.

Dr Michele Koo, MD, Board Certified Plastic Surgeon, Member of the Aesthetic Society can create beautiful augmented breasts for you with saline or silicone breast implants. Your breasts can be enhanced to full, round, sexy breasts that still look and feel completey soft and natural. Dr Koo can create the breast cleavage that you have always wanted with breast enlargement using breast implants. 

Dr Koo performs the breast enhancement with either an incision under your breasts or around your areola. She places the implants in one of two positions, either under your muscle or under your breasts. Dr Koo will decide the pocket for your breast implants after she examines you and determine which is the perfect surgery for you depending on what you want your breasts to look like.  The surgery is an outpatient procedure under general anesthesia and you will be able to drive the next day and return to an office type occupation after 1 or 2 days. After the surgery you are given a surgical compression bra which you will wear continuously for 4 days. There is very little discomfort after the surgery and Dr Koo does not need to use pain pumps and you may only need tylenol or an anti-inflammatory medication after for the slight pressure that you feel.

You will be able to do light exercising in 2 weeks and full cardio exercising in 4 weeks. You will look awesome in a swim suit in 4 weeks and be ready for any social event with low cut dresses and tops in 2-4 weeks.

The breast implants that are available now are silicone and saline implants and both are perfectly safe. Dr Koo will use either MENTOR or ALLERGAN NATRELLE breast implants depending on the shape and size of your own breasts and what she feels she needs in order to make your breasts the best that they can be.

The surgery takes less than one hour and you will go home that day and feel fine by that afternoon. There is only some minor discomfort and pressure from the tight surgical bra that Dr Koo gives you. Dr Koo then sees you in the office 4 days after the surgery when you will be able to see your beautiful full augmented breasts.

The breast implants whether it is saline or silicone will need to eventually be replaced in 15-20 years. the replacement surgery is relatively minor and takes even less time than the original surgery if you do not need a breast lift or other procedures with your breast implant replacement. You will be able to still undergo mammograms with breast implants in place. Dr Koo’s office, St Louis, Missouri, 314-984-8331, will make sure that you are seen every year in follow-up with Dr Koo for a professional breast examination and that you will have regular mammograms according to recommendations depending on your age.

At the time of your breast augmentation, Dr Koo can also perform a breast lift if necessary or other procedures to correct any breast asymmetry.

Call DR MICHELE KOO, MD, FACS, 314-984-8331, ST LOUIS, MO, to begin your journey to feeling more confident and sexy with your very natural looking and feeling, full, round, sexy breasts after BREAST ENHANCEMENT - BREAST AUGMENTATION WITH BREAST IMPLANTS.

BEFORE BREAST AUGMENTATION 34A

AFTER BREAST AUGMENTATION 34D

DR.  MICHELE KOO, MD, FACS MISSOURI, ILLINOIS, KANSAS, 314-984-8331

Dr Koo feels that there are certain facts that you should know about breast augmentation and breast implants and she wants you to be well informed. The better informed you are, the better your results will be as she will be able to communicate with you as to what your possibilities are. Her time is your time and she wants your surgery to be as perfect as it can be and that the size, shape, and look of your breasts will be exactly what you picture in your mind.

The following is an article in the Plastic and Reconstructive Journal that Dr Koo wants you to have access to by Dr William Adams of University of Texas Southwestern Medical University, December 2008. Dr Koo has her own techniques that are variants what is mentioned in the article but wants you to understand the preparation and techniques that go into determining your ultimate choice of implants, size, position, shape, and look of your breasts.

A process is defined as a group of practices that are completed successively to reach a goal. For 45 years, breast augmentation has been thought of as an isolated surgical procedure; however, well-documented elevated reoperation rates of 15 to 24 percent over 6 years in successive premarket approval studies have resulted in a critical analysis of this procedure. Factors that impact outcomes have been identified and practice recommendations have been established.

Background: Breast augmentation has been an integral part of plastic surgeons’ practices for over 40 years. Although devices have evolved, patient outcomes are still not ideal, as documented in multiple premarket approval clinical trials. Unlike many other areas of surgery, the practice of breast augmentation has suffered from the lack of a defined process for patient management. The purpose of this study was to clinically define and evaluate the process of breast augmentation and analyze patient outcomes using these practices compared with existing premarket approval trial data.

Methods: Three hundred consecutive primary breast augmentations from 2001 to 2005 were followed prospectively. Each patient underwent a defined process of breast augmentation including structured patient education and informed consent; tissue-based preoperative planning consultation; refined surgical technique; and structured postoperative instructions, management, and follow-up.

Results: The mean follow-up was 2.1 years. The most common complications were rippling and palpability, soft-tissue stretch, and hypersensitivity. The overall reoperation rate was 3.7 percent for the entire group and 4.7 percent and 2.9 percent for saline and form-stable cohesive gel implants, respectively.

Conclusions: Optimizing patient outcomes in breast augmentation requires defining the overall process to allow for enhanced patient outcomes. This is the first report that defines and integrates the entire process comprehensively that is validated by outcomes data. This process is transferable to other surgeons and, using this algorithm, patient outcomes in this study were superior to premarket approval clinical trial data. In summary, approaching this procedure with a global process produces superior patient outcomes in breast augmentation.

Dr Michele Koo, MD, Board Certified Plastic Surgeon, St Louis, Missouri, 314-984-8331.

Breast augmentation is an extremely popular and safe surgical procedure that 100’s of thousands of woman have undergone without any complications. The majority of these woman are extremely happy and would choose to have to surgery again if given the choice to do over again. In 2007, the FDA again allowed the use of silicone gel implants for elective breast augmentation for cosmetic reasons.

However, with time and aging of the implant, the breasts may change and the implant become encapsulated (scar formation around the implant). The breasts may become hard and misshapened and painful. The breasts may become too saggy and heavy and extremely uncomfortable for the woman.

Breast implant removal and replacement along with a breast lift is very safe and often a normal sequelae to breast augmentation that is over 15-20 years old. The recommended life of a saline or silicone implant is approximately 15-20 years. Whether a breasts starts to show the changes of encapsulation (hardening) and pain depends on where the original breast implants were placed, the original type of implant, and, of course, the patient herself.

The surgery that needs to be performed to change the breast implants is largely dependent on what was done at the time of the original surgery, whether the implant was placed under the breast or under the muscle, what type of implant was used, and what the breasts look and feel like in its current condition.

A breast implant exchange or a complete breast implant removal without an implant replacement can be performed. If the breasts have become saggy and have fallen so that they are too low on the chest, a breast lift may have to be performed at the same time as the breast implant replacement or removal. All of the above procedures can be performed very safely in one procedure by DR MICHELE KOO, MD of St Louis, MISSOURI, 314-984-8331.

There are a few points that Dr Koo wants you to understand about breast implants and breast augmentation according to an article by John B Tebbets in the Journal of Plastic and Reconstructive Surgery.

Factors That Affect Responses to a Breast Implant

Every medical device implanted into the human body is placed in an environment where certain factors cannot be predicted or controlled by the surgeon or the patient, especially factors related to a patient’s individual wound-healing characteristics and the genetic characteristics of each individual patient’s tissues.

A breast implant has a range of effects when placed into the body, effects that continue for the entire time the device is implanted. Short- and long-term effects of a breast implant in the body depend on three different sets of factors: device-related factors, surgery-related factors, and factors related to the patient’s wound-healing and genetic tissue characteristics. Surgeons and patients have some level of control over device-related and surgery-related factors, including implant type and size, maximal soft-tissue coverage over the implant, and optimal surgical techniques to minimize tissue trauma and bleeding. Neither surgeons nor patients, however, can predict or control patient wound-healing and genetic tissue characteristics.

Factors That No Surgeon or Patient Can Predict or Control

No surgeon or patient can predict or control a patient’s wound-healing characteristics or a patient’s genetic tissue characteristics, factors that can affect outcomes following breast augmentation. Each patient has unique, individual wound-healing and genetic tissue characteristics that influence the interaction between a breast implant and the surrounding tissues. Individual wound-healing characteristics influence the characteristics of the capsule or lining that forms around every breast implant and affect the degree to which that capsule tightens or contracts, which in turn determines whether capsular contracture will cause excessive firmness of the breast or other deformities. A patient’s wound-healing characteristics may also affect the quality of incision scars, the risks of infection or fluid production around an implant, and other factors that can affect the aesthetic result. Genetic and hormonal effects of pregnancy and nursing vary from patient to patient and can affect aesthetic results and outcomes.

A patient’s genetically determined tissue characteristics can affect the response of the patient’s tissue to the implant, including how much the skin will stretch and thin in response to a specific size implant and how the breast tissue overlying the implant will respond. Surgeons and patients can avoid selecting excessively large implants, but even an appropriate-size implant for a patient’s visible tissue characteristics may cause excessive stretch of the breast skin envelope in patients whose tissues do not adequately support the weight. Unfortunately, surgeons have no tests available to predict a patient’s wound-healing or tissue responses to a breast implant. As a result, no surgeon can predict or control the occurrence or severity of capsular contracture, infection, tissue stretch deformities, or other conditions relating to patient wound-healing and tissue characteristics.

Reoperations: The Risks, the Tradeoffs, and the Logic

Every additional reoperation that is required following placement of breast implants imposes additional risks, costs, and tradeoffs to the patient. Some reoperations are medically necessary, but others are not. Severe capsular contracture, infection, and fluid accumulation around an implant are medical reasons to perform an additional operation. A patient’s request for a size change to a larger or smaller implant, though desirable to the patient, is not medically necessary and imposes risks and costs that may not be logical medically. For example, although the risk of infection with implant exchange is small, it is not zero, and for the patient who experiences such a complication, the incidence is 100 percent and may require implant removal without replacement or may produce an uncorrectable deformity.

Every reoperation causes additional surgical trauma and bleeding, and healing after each additional surgery produces more scar tissue, the effects of which are uncontrollable. Seemingly simple operations such as a minor revision for implant malposition or excessive stretch, though usually safe, invoke healing mechanisms that are uncontrollable and can result in exchanging one deformity for another. Logically, reoperations should not be performed for reasons that have no medical necessity or to address relatively mild aesthetic conditions where the risks and effects of the surgery might possibly produce a change that is worse or different compared with the existing condition.

Implant Removal without Replacement: The Logic

Breast implants are not medically necessary devices. Regardless of the efforts and costs to place breast implants, if certain conditions or complications occur, continuing to attempt to salvage the implants or leaving implants in place can cause permanent damage to a patient’s tissues, producing deformities that are uncorrectable.

Once a patient has breast implants, virtually every surgeon and patient wants to keep the implants in place. The positive effects of implants make some patients unwilling to even consider removal without replacement under any circumstances. Removal without replacement must be a joint decision of the patient and surgeon, both of whom must recognize and acknowledge that the aesthetic consequences of removing implants may be far more preferable to possible permanent, uncorrectable deformities and additional reoperations with additional costs and risks if the implants are left in place. Surgeons and patients should define criteria for removal without replacement before the patient has a breast augmentation, and the patient should understand and document her acceptance of these conditions in informed consent documents. A surgeon’s willingness to adhere to stringent criteria for reoperations directly influences reoperation rates, risks, tradeoffs, and costs to the patient.

Unilateral versus Bilateral Implant Removal

When a condition requiring implant removal occurs unilaterally, removal of one implant creates a deformity (asymmetry) that virtually guarantees at least one reoperation to replace the implant. Unilateral implant removal encourages patients and surgeons to prioritize implant replacement, often sooner than is medically optimal. Unilateral implant removal can compromise future decisions and the timing of those decisions. When removal is indicated, bilateral implant removal totally avoids these compromises and eliminates a demand for reoperation based on asymmetry.

Implant Removal without Replacement: The Criteria

Every surgeon must define personal criteria for implant removal without replacement, based on clinical experience, medical indications, and logic. On the basis of more than two decades of experience, I recommend breast implant removal without replacement for the following clinical conditions or situations, and I require that every patient accept and acknowledge these criteria in informed consent documents before the primary augmentation

* Recurrence of capsular contracture after having performed a complete capsulectomy and implant replacement with a new (textured saline if the primary was silicone gel filled) implant for a first capsular contracture of grade III or IV (limits total reoperations for capsular contracture to two).

* Recurrence of stretch deformity (bottoming, lateral malposition) after having performed a previous capsulorrhaphy, partial capsulectomy (if indicated), and exchange to a smaller implant (limits total reoperations for stretch to two).

* Traction rippling or visible implant edges medially when there is no additional tissue coverage available locally (e.g., conversion of submammary to subpectoral), or when pectoralis coverage has been previously compromised by division of medial pectoralis origins.

* Culture-documented contamination or infection of the periprosthetic pocket, regardless of implant type or pocket location (any occurrence of documented infection). This approach optimizes rapid resolution and minimizes inflammatory effects on tissues that occur with prolonged salvage efforts, effects that may produce significant and sometimes uncorrectable tissue deformities over time. Further, this approach minimizes the risks and costs of future reoperations attempting reimplantation, and it eliminates reoperations for recurrent infection or capsular contracture that can occur after attempted reimplantation.

* Recurrent seroma, regardless of negative cultures, after treatment of an initial seroma with exploration, capsulectomy (if indicated), and prolonged drainage.

* Inadequate soft-tissue coverage, when pinch thickness of tissues covering any area of the implant is less than 0.5 cm (except when coverage deficit is medial or superior and can be improved by dual plane or retropectoral implant placement).

* In any situation where two previous reoperations have been performed, for any reason (limits reoperations to three, including removal without replacement).

Criteria to Limit Reoperations

The following criteria have evolved over more than two decades to limit reoperations with their inevitable risks, tradeoffs, and costs:

* No reoperations for implant size exchange if not medically necessary (e.g., a slightly larger implant after performing a capsulectomy, provided adequate soft-tissue coverage is available).

* No reoperations for grade II capsular contracture.

* No reoperations for minor stretch deformities [<3 cm of additional widening of the intermammary distance due to lateral envelope stretch, <2 cm of elongation of nipple-to-inframammary fold distance (bottoming) 6 months or more postoperatively regardless of emptying of upper breast or slight excess volume in lower breast].

* No reoperations to adjust nipple-areola position if sternal notch-to-nipple distances are within 1.5 cm bilaterally (for either primary or secondary procedures).

* No implant replacement if patient has previously required bilateral implant removal for any condition or suspected condition, including replacement of saline-filled implants following removal of silicone gel-filled implants to address concerns of connective tissue disease or other undefined symptom complexes or psychological conditions.

* No reoperations if patient is unwilling to sign detailed informed consent documents acknowledging that she understands and accepts that every reoperation involves additional risks, tradeoffs, and costs, that correction of any condition by reoperation is not guaranteed, and that with any reoperation, we may exchange one set of problems or compromises for a different and not necessarily better set of conditions.

Results

The above-described criteria, combined with implant selection based on quantifiable tissue characteristics and more detailed patient education and informed consent were applied in 1662 reported cases using textured, saline-filled breast implants with up to 7 years of follow-up. The resulting overall reoperation rate was 3 percent. Acknowledging the limitations of comparing the studies, this 3 percent overall reoperation rate at up to 7 years compares favorably to the overall reoperation rates of 13 and 21 percent at 3 years in the saline premarket approval studies of Mentor and McGhan and to the 20 percent reoperation rate at 2 years in the most recent silicone gel premarket approval submission by Inamed Corporation.

Discussion

Factors such as the surgeon’s experience, the surgeon’s technical skill, the reasons for reoperations (device-related versus surgery-related), and other factors preclude direct, scientifically valid comparisons between our reoperation rates and those of the premarket approval studies. Nevertheless, the large clinical experience with long-term follow-up reported in our studies includes every reoperation for any reason, similar to the premarket approval study results. In the premarket approval study, capsular contracture was categorized as a device-related reason for reoperation when in fact surgical tissue trauma and bleeding are significant if not major stimuli for capsular contracture. A reoperation is a reoperation, regardless of whether the patient requests it for size change or an improvement in aesthetics. Selective categorizing and analysis to shade interpretation of results and causes is largely nonproductive, if reducing reoperation rates is a goal. By defining and implementing out points and decision and management algorithms, we have dramatically reduced reoperation rates in our practice over the past two decades.

Conclusion

To reduce the rate of reoperations, with their inevitable risks, tradeoffs, and costs to patients, and to reduce the incidence of tissue-compromising deformities resulting from multiple reoperations, surgeons must define strict criteria for reoperations following breast augmentation and for bilateral implant removal without replacement. The criteria described in this article resulted in overall reoperation rates that are substantially lower compared with overall reoperation rates in recent large premarket approval submissions to the Food and Drug Administration. Each surgeon must define criteria according to his or her individual surgical experience and practice characteristics, but current Food and Drug Administration rulings and guidance suggest that continued availability of breast implant devices for patients demands that patients experience lower reoperation rates.

Dr Michele Koo feels very strongly that her patients can benefit from primary breast augmentation for elective cosmetic reasons as well as from breast implant revisions should the need arise. However, as the article above emphasizes, re-operation for breast implants have certain risks and complications that are out of the control of the surgeon and the patient. Dr Koo wants the best outcome for her patients and she feels that the better informed one is when going into the initial surgery, the easier it will be for all subsequent surgeries.

Dr Koo wants her patients to understand that no matter how pleased you may be with the original breast augmentation or revision surgery that once a breast implant is used, that will then obligate you to subsequent surgeries whether it is for an implant replacement after many years, or whether it is due to your breasts changing shape and size after children or weight gain and loss.

BREAST AUGMENTATION SILICONE & SALINE IMPLANTS 

DR MICHELE D KOO, MD, FACS

ST LOUIS, SPRINGFIELD, COLUMBIA, KANSAS CITY

MISSOURI

Before Breast Augmentation 32 B

After Breast Augmentation 34 D

Silicone breast implants have been again approved by the FDA for cosmetic breast augmentation by plastic surgeons. They are safe and may benefit so many woman who seek breast enhancement to feel more confident in themselves and feel better. No matter what your goal is for the look of your breasts, Dr Michele Koo, MD, FACS, 314-984-8331, understands what you want and will be able to deliver the perfect look to meet your goals. Whether you just want a little fullness or very full voluptous breasts, Dr Michele Koo can achieve what you are looking for safely and effectively.  

To quote Rod J. Rohrich, M.D., co-editor of The Plastic Surgery Journal…….

“Nothing reminds me more of my duties as a surgeon than the words of Cicero: Salus populi suprema lex (literally, the safety of the people is the supreme law). The rough American proverbial equivalent that children across America hear every day is, of course, safety first. It’s a simple principle that guides my every action when teaching my students and treating my patients. Unfortunately, it’s a simple principle with a lot of gray areas. Safety can easily transform into paranoia, fear, and lost opportunities if we forget to balance our lives and ethos with well-thought-out risk, chance, and advancement.