So, you’re thinking of having breast surgery…augmentation, reduction, lift, or perhaps implant exchange. What do you ask your plastic surgeon and how do you know she is qualified? Most importantly, how can you be sure she will take care of you and keep you are safe?

First, you want to make sure your plastic surgeon is Board Certified and a Member of the Aesthetic Society if you are considering any kind cosmetic procedure.

Second, do your research. Insist upon seeing photographs of your plastic surgeons previous patients and ask to speak with them regarding their experience. Check out your surgeon’s website. Does their philosophy and approach resonate with you?

Third, during your consultation, ask yourself if you feel comfortable with your surgeon. Do you trust her? Do you click with her? Do you like her? These impressions are imperative when choosing your surgeon, because your relationship is just as important as the results with which she will provide you. This bond will not only make you feel safer but also provide your doctor with the insight to give you exactly what you want.

Last, ask your friends who they’ve seen. Were they happy with their results? Would they go back? This will help you make an informed decision.

Good luck with your search!!

As women who have had breast implants age along with their silicone or saline breast implants, the number of breast implant failures and problems with deflation, rippling, and capsular contractures continue to increase.

This is not unexpected as the life of a saline implant may only be 10-15 years and the life of a silicone implant 20-25 years. The breasts may become firm or actually very painful and hard, they may become misshapen and asymmetric, they may become malpositioned or start to droop with the breast and become very unsightly for the woman.

Many women keep putting off the inevitable which is to have the breast implant replaced or removed entirely with or without a simultaneous breast lift.

The first thing you should know is that breast implant replacements are safe and may take 1-3 hours of surgery under general anesthesia. The surgery time depends on how much capsular contracture (scarring) there is and whether a breast lift is performed at the same time. Some women opt to have the implants removed and not replaced and have a breast lift to remove the excess breast skin that remains after the implant is removed and want a smaller maintenance free breast in the future. (more…)

So you’ve had a few kids and now you’re 20-40 lbs heavier with breasts that are deflated, stretch marks all over your tummy, belly button & breasts. You have skin that hangs over your pubic area that prevent you from being able to tuck in any shirt or find clothes that fit nicely.

You try to eat well, exercise, and be healthy but all you see are your flat saggy breasts and hanging tummy skin. You get discouraged and depressed and you eat that extra piece of cheesecake because … what’s the use, nothing makes any difference!

Let me tell you, break the vicious cycle and take charge of your life. It is true, you will not be able to make the skin shrink or lift your breasts with diet and exercise but it will make you mentally feel better until you can get a MOMMY MAKEOVER!!

What is a MOMMY MAKEOVER? It can consist of a breast augmentation with a breast lift, tummy tuck with liposuction, and/or brachioplasty to reduce the skin of the arms. You can have all of these surgeries done at one time with one recovery depending on how much excess skin and fat will be taken off.

(more…)

So you’ve been considering a breast augmentation forever but you just don’t know if you will have breasts that look and feel REAL afterward…will he be able to tell that you have breast implants??

Do not worry, let me reassure you that an augmented breast DOES look and feel REAL!

How is that possible…?

Because the implants will become integrated with your own breast tissue and feel like one. They will bounce when you bounce and remain soft. The big difference is that you will have beautiful full round breasts. Of course, you will have firmer breasts, which is one of the reasons you are getting breast implants in the first place. They will remain soft and feel very natural. You want breasts that don’t sit flat on your chest. You want breasts that stand away from your chest and only have a little bit of skin contact with your upper abdomen (to hold only 1 pencil and not an entire pack of pencils)! That is what a breast implant will do for you, firmer, fuller, rounder breasts that are soft and move when you move.

There are now an entire spectrum of different sizes and profiles (height to width ratio) of breast implants that will deliver not only the most proportionate beautiful cup size of your choosing but also the shape that is in keeping with the length of your torso and how soft a drop you wish.

Some women want that full, up, round, in your face breasts that sit high and round. Some women prefer a slope and gentle fall and a slightly lower breast. You can actually bring pictures to your plastic surgeon’s office and discuss the actual contour of breast that you want.

When the swelling resolves, your breasts will be soft, move, bounce and be part of you. No one looking or touching your breasts will be able to tell you have implants…the give away that you MIGHT have breast implants…they will be TOO PERFECT to be real!!

What you decide to say to him is totally up to you, and truthfully you never have to say a word if you don’t want. The scars will fade and can be placed in your own natural creases so they actually look just like a skin crease.

After Breast Augmentation

Before Breast Augmentation

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

The following is an article by Gary S Brody, Professor Emeritus, University of Southern California, Keck School of Medicine.

I hope you find this article interesting and informative on the history and development of breast implants and of silicone use in breast implants. It will be divided into 4 parts on my blog page. It is important to know and understand the controversy that centers around breast implants and especially silicone breast implants.

History of Breast Implants

The number of women in the United States who have breast implants is unknown, but current estimates derived from national surveys range up to more than 6 million. This represents more than 5% of the adult female population. The American Society of Plastic Surgeons (ASPS) collects information annually on plastic surgery procedures performed by its members. In 2008, approximately 307,000 women received breast implants for cosmetic breast augmentation and 111,000 for reconstruction of congenital or postmastectomy deformities. These data do not include those procedures (mostly cosmetic) performed by non plastic surgeons such as otolaryngologists, general surgeons, gynecologists, and others.

Following adverse publicity in the early 1990s, interest in the procedure fell significantly, especially for gel-filled devices, but it seems to have recovered incrementally. According to the ASPS, in 2008, 53% of total breast implants were filled with saline; 47% were filled with silicone.¹

Prior to 1963, various plastic foam materials were used; for breast augmentation, however, it became apparent that the air cells would collapse and, combined with tissue ingrowth, shrink and harden the device. These materials were wrapped in plastic film to minimize this effect to no avail. Amazingly, some of these implants were so well tolerated that they have stayed in place to this day.

The modern silicone breast implant has been available since 1963 and has gone through an evolution of change and improvement. Several types of devices, with many variations, shapes and styles within each class, are now available or under testing for US Food and Drug Administration (FDA) approval. Basic to all implants is a silicone rubber (elastomer) shell, which can be single or double, smooth or textured, barrier-coated, or covered with polyurethane foam. The foam-covered devices have not been available in the United States since 1990 but are still marketed in Europe.

The contents are either factory-filled with silicone gel of various consistencies or inflated at surgery with normal saline. One brand that was manufactured overseas was prefilled with saline at the factory. It was briefly marketed in the United States but was later withdrawn when the FDA denied approval.

The double-lumen devices consist of concentric balloons that contain silicone in one chamber and saline in the other. The only one still in use is the Becker, which has an outer layer of gel and an inner balloon that is valved to permit postoperative gradual inflation with saline. This is termed a “permanent tissue expander,” since it permits gradual and temporary overinflation to create the pocket and then can be left in as a permanent implant after the size is adjusted appropriately. At this writing, the Becker devices are not generally available in the United States until current FDA mandated studies are evaluated.

In 1990, the FDA placed a moratorium on gel-filled implant use for cosmetic augmentation. They remained available for reconstruction and replacement, but mandated extensive record keeping, follow-up, and IRB approval were required for use. In 2006, after extensive study and analysis, the FDA deemed the device safe for all augmentation and reconstructive purposes, but they continue to require tracking of patients.

Saline Implants

Saline filled implants are available as empty silicone balloonlike devices to be filled with normal saline at the time of surgery. This permits subtle size adjustments to compensate for asymmetry between the breasts. They are less popular than silicone implants, as they often may have a less natural feel. If the patient has very little breast tissue or only a skin covering after mastectomy, unsightly wrinkles and folds of the device may be visible on the breast. This is more common when the surface is textured.

Silicone Gel Implants

Three generations of basic design of this device have been created, with many variations within each type.

First generation

The first models to be marketed had envelopes of thick, smooth-walled silicone elastomer made in 2 sections, filled with a viscous silicone gel material (dimethylsiloxane) and glued together. They were available in only three sizes: small, medium, and large. In the first few years, surgeons believed that the device required attachment to the tissues to prevent migration. Scar ingrowth for fixation was accomplished by patches of material (eg, Dacron mesh or perforated silicone) attached to the back of the device or by an outer covering of polyurethane foam. The Dacron and silicone patches were subsequently found to be unnecessary; they actually detracted from the quality of the result. Some patches or tabs created a stress point that led to tears of the envelope. Fixation patches were eliminated in the early 1970s.

Second generation

Manufacturers varied the gel consistency and shell thickness in an attempt to improve performance. Beginning in the mid-1970s, the shells were made thinner and the gel less viscous (ie, more “responsive”), primarily in an ill-conceived attempt to control hardening from scar shrinkage (capsular contracture.) This trend reversed in the early 1980s when it was recognized as not effective in reducing contracture and as resulting in a more fragile device. Most were broken 10 years later.

Third generation

New formulations of the shell and gel contents became available that were stronger and had a second barrier coat of diphenyl silicone. This coating almost totally eliminated so-called “gel bleed” or diffusion of small amounts of the silicone oil through the implant shell. The gel content also was made more viscous and cohesive.

In 1989, textured-surface shells that many surgeons hoped would minimize the incidence of unwanted firmness from capsular contracture became available. Recent studies are somewhat confusing regarding whether this was effective. The textured implants had the disadvantage of a higher rupture rate than the more traditional smooth shells and often produced visible wrinkles in the breast in women with very little overlying tissue to mask the ripples. Because of these shortcomings and lack of solid evidence that these devices were softer, they have become much less popular in recent years.

Polyurethane-covered implants

In the late 1960s, a variation of the device was developed containing a polyurethane sponge coating over an otherwise standard gel-filled implant. Although the coating originally was planned as a fixation layer, many surgeons came to believe that the foam cover resulted in a decreased incidence (or at least a delayed onset) of capsular contracture. These implants also evolved in shape and design, culminating in the early 1980s with the Meme and Optimam styles. In April 1991, the manufacturer voluntarily withdrew the foam-covered implants from the market.³

One style, the MemeME, had a unique construction. It had no true shell, but a skin of sorts was formed in situ by spraying the surface with silicone containing extra catalyst prior to curing. This increased the crosslinking of the surface to create a shell-like membrane. The polyurethane foam was then shaped and sealed over the surface. Implants of this particular type were known to occasionally extrude some of their gel contents through the foam when squeezed. This is a possible explanation for reports of blood being found within the substance of the gel in apparently intact implants. The MemeME model was marketed from 1983-1988.

Other filler materials

While silicone remains the only available shell material, new filler substances were in use in Europe and South America and, at one time, were under development or in experimental trial in the United States. Various hydrogels and a pure form of triglycerides were the 2 main formulations. The major advantage of the triglyceride formulation (Trilucent) was that it had a Z number (measure of radiolucency) similar to that of fat, thus resulting in little or no compromise of mammography. Another fill substance, polyvinyl pyrrolidone in saline, was briefly available, under the trade name Misty Gold. None of these products is currently available in the United States. At this time, only silicone gel or saline-filled models are available for use in the United States.

Recent developments

In late 2006, a new formulation of silicone gel filler called MemoryGel (Mentor Corp, Santa Barbara, Calif) gained FDA approval. This gel implant is thicker and more cohesive so as to minimize gel spread in the case of rupture and to resist scar shrinkage that would deform its contour. When cut, the gel retains its shape and doesn’t run. This device has a doughy feel to it.

Currently available devices in the United States are saline- or silicone-filled implants with either textured or smooth surfaces. They come in round or tear drop shapes with a choice of 3 different projections. Only 2 companies, Mentor Corporation and Allergan (a successor to McGhan and Inamed), have FDA approval to market these devices in the United States.

The implants produced currently are much improved devices compared to earlier units. The shell is still made of an outer layer of a mix of dimethyl siloxane and amorphous silica with an inner barrier coat of diphenyl siloxane to minimize silicone gel bleed. The shells, on testing for breakage, exceed the American Society for Testing and Materials (ASTM) requirements by more than 300%. The gel is more cohesive, varying from a standard 60% crosslinking to 80% for the more cohesive type nicknamed “gummy bear” (because of is consistency similar to the candy).

As evidenced by sales figures prior to the moratorium, and now following their release for cosmetic purposes, approximately 80-85% of surgeons and patients prefer the quality of results obtained by gel implants, making them the implants of choice. In 1997, sales figures for Europe, where usage was unrestricted, show a distribution of 70% for gel, 15% for saline, and 15% for alternate fills such as triglycerides (then still available) and hydrogels for cosmetic use.

CONTINUED ON NEXT HISTORY OF BREAST IMPLANT BLOG PART 2

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