Articles Provided by Dr. Teitelbaum of Santa Monica

NOTE: In the United States, cohesive implants are investigational devices, and are available only to select surgeons, and patients participating in clinical trials.

Dr. Teitelbaum is an authority in the field of cohesive gel breast implants, and has lectured about them to other plastic surgeons. He is the only physician selected to be a participant in all 3 clinical trials being conducted in the United States on cohesive silicone gel breast implants: these include implants made by Inamed (formerly McGhan), Mentor, and Silimed.

Enrollment is still open for both the Mentor and Silimed trials. The Inamed trial is currently full, but additional enrollment may occur this fall.

Because participants must be available for annual follow-up for 10 years, Dr. Teitelbaum will only enroll patients in the Southern California area; patients from other areas should contact Mentor or Silimed to find a surgeon in their area.

We will try to keep this information current. If you are interested, please call the office at 310-315-1121 for the latest information.

Updated 9-23-04

OVERVIEW

Cohesive breast implants were invented in the early 1990s, and have been used throughout the world for about 10 years. Only the United States has yet to approve these devices. Though the experience of these implants overseas will be taken into account, the FDA requires that a prospective large-scale study be done in the United States, adhering to their rigorous guidelines and scrutiny. These implants are not approved by the FDA. It is only in the context of such a study that these implants are available in the United States.

These implants were originally invented with two purposes in mind: 1) to make a longer- lasting implant, and 2) to make an implant that would maintain a more attractive and predictable shape. This goal is primarily achieved by making the gel more cohesive, so that it is less liquid-like and more solid than other silicone gel implants. For this reason, they have been known as the "gummy bear implants" Though preliminary data suggests these implants might be meeting its goals, prospective enrollees must understand that these claims have not yet been proven.

Three companies are currently doing clinical trials in the United States: Inamed, Mentor, and Silimed. Each company's devices are based upon similar concepts, but there are very significant differences between them.

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Some women consider this an opportunity to have a chance to be the first to get what may be the implant of the future, while other women feel uncomfortable being a participant in a study of a new medical device. Only women highly motivated to receive these implants, and who are willing to participate in the study for 10 years of follow-up, should consider these devices.

More Information about Cohesive Gel Implants

Frequently Asked Questions
History and Rationale for Cohesive Gel Implants
Advantages of Cohesive Gel Implants
Disadvantages of Cohesive Gel Implants

Frequently Asked Questions

What Are Cohesive Gel Breast Implants?

The standard implant in the United States has been saline filled, ever since the FDA moratorium on silicone gel filled breast implants in 1992. The type of implants that were available before the ban are available today as part of an "adjunct study," which is open to patients with congenital deformities or having a revision for particular reasons. (refer to section on this in website.)

What distinguishes cohesive implants is that the silicone gel is firmer, essentially a soft solid. If a cohesive implant is cut in half, there is no gross movement of gel, and the implant maintains its shape.

The way these are made is that the company uses more "crosslinker" in the making of the implant. The ingredients are the same, but with more crosslinker added, it makes the gel firmer. The term "cohesive" has been bastardized in recent years. Cohesive breast implants implies form stability, or form retention. That means that in any position, the implant maintains its shape. That is an important distinction, because it means that the shell should not fold, and that it will maintain a particular shape.

Unfortunately, given the recent media attention to cohesive implants, many are using the term to describe "regular" silicone gel implants. Technically, they are correct; all silicone gel is cohesive to some degree. But the term cohesive has always meant form stability, and when patients ask for cohesive gel, it is because they are looking for an implant with those particular characteristics of durability and shape retention. Hopefully, the terminology will be clarified in the coming years.

Which Surgeons Can Use Cohesive Gel Implants In The United States?

Each of the three studies has a group of only several dozen surgeons that are allowed to order the implants and implant them. Surgical expertise and a commitment to careful patient follow-up were the criteria the manufacturers used to select the surgeons that they would have implant their implants. Dr. Teitelbaum is the only surgeon in California (and if not the only, one of the very few in the entire nation) to have been asked by all three manufacturers to participate in their clinical trials.

Which Patients Can Receive Cohesive Gel Implants In The United States?

The trials are open to patients seeking a first time augmentation, a revision of a breast augmentation, or breast reconstruction following mastectomy. Patients with certain medical problems cannot participate. Please see the enrollment specifications for each of the implants listed below. In addition to the objective medical issues, patients must be committed and willing to participate for a full ten years of follow-up to be considered for the study. Patients must be in the immediate geographic vicinity of the implanting surgeon in order to facilitate this follow-up.

What Are The Main Advantages Of Cohesive Gel Implants?

The main advantages of cohesive gel implants are longevity and shape. Longevity, because they do not develop folds, and it is along folds that implants ultimately fail. And if, somehow, the shell does fail, since the gel is so thick, it hopefully will not migrate anywhere in any significant quantity. Shape is enhanced because, from the point of view of a surgeon, there is only control of breast shape if there is control of distribution of fill in an augmentation. If the fill cannot be controlled, then the shape cannot be controlled. And to control distribution of fill in the breast, fill distribution must be controlled in the breast implant. All fillers other than cohesive silicone gel - saline or regular silicone gel -can migrate around within the shell of an implant, which means that there is not control over breast shape. Looking at results from breast augmentation objectively, these implants appear to have the most aesthetically natural and beautiful results.

Why Are Cohesive Gel Implants Anatomically Shaped?

A breast projects more at the bottom than at the top. Therefore, it makes sense for an implant to be shaped that way. And the thinner an implant is at the top, the more gradually and naturally it will feather into the upper chest, making itself less conspicuous. Without a cohesive, form stable filler, there is little point in making shape into an implant, as the implant will ultimately lose the shape. But with a form stable filler, the shape will be maintained.

Are There Round Cohesive Gel Implants?

Form stable round cohesive gel implants are available in Europe, but not in the United States. There is actually very little use for them. If you look at an implant lying on its side on a table, it looks much like an M&M. But when it is held upright, the upper pole gradually collapses. It is that upper collapse that allows those implants to look natural (though it is doing so at the risk of folds on the implant shell.) A true cohesive round does not do that. By maintaining that M&M shape when vertical, it creates a dome-like, relatively top-protruding shape.

However, cohesivity is not a black and white issue; there is an endless continuum in cohesive gel from very liquidy to very solid. On Silimed's cohesive clinical trial, there are 4 different round gel options. These are more cohesive than implants made in the past, and can be considered cohesive, but they are not as cohesive as their anatomically shaped cohesive gel implants or the anatomic cohesive implants by Mentor or Inamed. They fold less than gel implants of the past, but they are not quite form stable, in terms of their ability to resist folds or predictably maintain a shape.

Do Cohesive Gel Implants Come With A Smooth And A Textured Surface?

All anatomic (a.k.a. teardrop) shaped implants are textured, as the texturing increases friction and helps keep them from rotating. Since a teardrop implant is different at the bottom than the top, it is important that it maintains its position.

The Silimed round implants come in both smooth and textured surface, but remember that while relatively more cohesive than most other silicone gel implants, they are not form stable like their anatomically shaped cousins.

What Happens If A Cohesive Gel Implant Ruptures?

We do not really know, because there is so little experience with this. At the time of writing this, there is report of a single rupture in a series of several thousand in Sweden. If it did happen, however, one would imagine that the gel, being relatively stiff and solid, would not migrate in any significant amount. Since it has the consistency of a gummy bear, the gel would presumably stay in place. Microscopic migration of gel would presumably occur, and this can even happen to some extent through an intact shell. This is a subject of ongoing investigation, and more research will be needed to answer this question.

How Would You Know If A Cohesive Gel Implant Has Leaked?

Given the gummy bear nature of the filler of these implants, it is likely that it would be difficult to tell if they ruptured. Perhaps it might be detected by mammogram or MRI. When any implant is placed in the body, the body forms a capsule around the implant. If a cohesive implant were to leak, it would probably just stay within the capsule. The capsule might thicken, and a patient may notice a difference in the feel of the breast. But it is also possible that there might be no change at all. The important point, however, is that silicone gel has not been linked with any health problem, so even if there were a shell disruption, it should not prove to be of any medical problem.

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History and Rationale for Cohesive Gel Implants

The rationale of cohesive gel implants can best be understood by tracing the development of these implants.

It all began with the successes and failures of an implant that was popular in the 1980s, the Replicon. This was an anatomically shaped, polyurethane coated, silicone gel filled implant. Many surgeons felt that the initial results were very beautiful.

But these results were short-lived. The polyurethane that was bonded to the surface of the shell helped to maintain the anatomic shape of the implant. But the body eventually degraded the polyurethane, and once it was absorbed off of the shell, the remaining thin and pliable shell could not hold the silicone gel in place, and so its shape was lost. It ended up looking like an under-filled round implant. Gravity forced the gel to the bottom of the shell, collapsing the upper breast, and expanding the lower breast. Folds developed in the collapsed upper pole. These could sometimes be seen or felt. The shell was very thin, and with time, the shell weakened along those folds, and eventually could break, allowing the relatively liquid-like contents of the implant to leak outside of the shell. In addition to the effects of gravity, the forces of the breast acted upon the implant, deforming its initial anatomical shape. The implant accommodated to the shape of the breast, rather than the breast taking on the shape of the implant.

How could an implant be made that could maintain these initial excellent results over the long term? Dr. John Tebbetts of Dallas, working with Dan Carlysle of McGhan (now called Inamed), are credited for trying to solve this problem. Though what follows is a simplification of a very long and highly technical process, the core theme is that they realized that the shell could not be solely responsible for maintaining shape; the contents had to hold a shape as well. So they experimented with making different silicone gel fillers. Silicone can be made in virtually any firmness, from a liquid lubricant to almost a rock-hard solid, depending upon how much "cross-linker" is added to the formula. Through experimentation, they were able to create an implant filler that was adequately soft, yet would maintain the shape that was molded into it. If the filler were form stable, then the gel could not fall to the bottom, leading to collapse of the upper pole, which is what led to folds and ultimately shell failures in other implants. And by being form stable, it would maintain the particular shape in which it was made, thereby allowing the surgeon to control breast shape.

With past implants, shape was of only moderate importance, as with non-form stable contents, the forces of the body and of gravity would shape the implant. But with this filler, the actual shape became a very important issue. They experimented with various ratios of widths, heights, and projections. They looked to create an implant that would create and maintain an optimum aesthetic balance to the breast.

The culmination of their efforts was the McGhan Style 410. Unfortunately, this was right in the middle of the breast implant crisis in this country, so the climate was not right politically to ask the FDA for approval of a new silicone implant. However, the implant was taken to Europe in 1993, and it has remained one of the largest selling implants in the world. For the United States, McGhan subtly redesigned the shell, and marketed a saline-filled version of the 410, called the 468.

Clinical Trials of the 410 began in the United States in 2001. Because of the similarity between the 410 and the 468, surgeons with significant experience were chosen to do the initial 410 study. Three year data has now matured, and Inamed will present this to the FDA late in 2004.

Subsequently, Mentor and Silimed developed their own version of the 410. Mentor's is called the CPG (Contour Profile Gel), and Silimed's is called

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Advantages of Cohesive Gel Implants

Though they have been used for ten years in Europe, the data from the US clinical trials has not matured to the point that we can argue any of these advantages conclusively. These are what is hoped will be proven to be the advantages, but the reader should realize that these are all unproven.

Shape - It does seem that these implants do maintain their shape, thereby making them able to impart their shape upon the breast. Non-form stable fillers, such as saline or standard silicone gel, are subject to the forces of gravity and of the breast, so that they assume the shape that the forces of the breast and the forces of gravity dictate. These implants have a distinct shape, and they will impart it upon the visible shape of the breast.

Folds and Rippling- Since the fill does not shift from one area of the shell to the other, shell collapse and folds do not seem to occur, even in long term follow up.

Won't Leak - There are two components to this issue. One is whether the shell might break, and the other is whether the gel will leak out if the shell does break. The shell is certainly physically susceptible to breakage, but since most ruptures are believed to occur along shell folds (they result in weakening of the shell, much like a folded newspaper left in a drawer will crack along its folds), it is expected that shell failures will occur less frequently. In the largest series in the world, there has supposedly been only one shell failure in several thousand implants done in Sweden. If the shell is peeled off the implant, the cohesive gel filler will maintain its shape. I have one that I did this to several years ago, and it looks just the same as the day I did it. But, that doesn't mean that in the warmth of the body, and with the forces that act upon the implant, that the situation wouldn't be different. Another issue is diffusion; though there is a layer of the implant shell that decreases silicone diffusion, some microscopic diffusion of silicone will always occur through the shell.

Capsular Contracure- The European experience has been that firm scar tissue seems to occur less often with these implants (capsular contracture.) It is not clear if this will be maintained over time, or what the cause is. Some speculate that it is related to there being less diffusion of silicone than with non-cohesive fillers, while others believe it is due to the increased firmness of the implant, which inhibits the body from contracting around it. More time and study will be necessary before we know the answer to this issue.

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Disadvantages of Cohesive Gel Implants

Shape- It is listed here for the same reason that it is listed as an advantage. Since it will impart its shape upon the breast, the patient and surgeon had better be sure that they are choosing an implant shape that they want the breast to have. While implant selection certainly matters with old style silicone gel and saline implants, since their shape so so affected by gravity and forces of the breast, there is a great margin for error. This is not a problem per se, but rather, this is an issue in which one must be aware of. For instance, women preferring "Baywatch"-grapefruit looking breasts may find the teardrop shape of this implant will not meet their expectations. I think this problem becomes significant only in "disproportionate" augmentations, situations in which the implant size chosen exceeds what is optimum for a patient's soft tissues.

Feel- These implants do feel a little bit firmer than old style silicone gel implants (though if the old ones get a capsular contracture, they will feel firmer…some believe that the cohesives are less likely to get such a contracture, but that is not yet known.) How significant this is in a given patient depends upon how much breast tissue they have relative to how large an implant will be chosen, and how firm or loose their tissue feels. A rare patient will complain about the firmness, but for most patients, particularly those getting implants that are not oversized, this is not an issue.

Cost- These implants do cost significantly more than saline, and several hundred dollars more per pair than old style silicone gel implants. However, if part of the study, patients will be reimbursed most of the implant cost over a period of ten years.

Incision Size- Since these implants are not deformable, they cannot be squeezed through little incisions. Depending upon the size of the implant, incision length must be between 4.5-5.5 cm. It also can make insertion from around the areola difficult (I usually use the underneath incision with the cohesive implants.) Armpit incision is possible, but exceedingly difficult.

Rotation- These implants only come in anatomical shapes, meaning that they project more on the bottom than they do on the top. One of the risks of such a design is that if the implant rotates in the body, it will create a distortion. Care is taken during pocket dissection and insertion in order to minimize this. It is a very rare, but very possible complication. The only way to fix it if it occurs is to remove them and replace them with a round implant. Rotation is at greater risk when the tissue is loose, for instance in a revision when a patient wants to go smaller.

Gel Fracture- Since the gel is almost a solid, it can actually crack. I have only seen this happen from excessive manipulation of the implant outside of the body, but it can theoretically occur in the body. No one knows if this can actually occur, or what the consequences would be if it were to occur. My speculation is that it would not be noticed, but the answer to this is not yet known.

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By now you're sure to have heard about the latest advance in breast implants – the cohesive or so-called "gummy-bear implant," which are all the rage in Europe. Thousands of European women are thrilled with their natural looking and feeling breasts and now select American patients can enjoy these phenomenal implants as well.

Although these implants are so new in the states that they have not yet been approved by the FDA, Dr. Teitelbaum has been using them in studies since 2000 and is one of the most experienced providers in the country! So experienced, in fact, that the manufacturers of these implants have asked him to help develop the curriculum to teach other surgeons how to use these implants. He has traveled to places as far away as Europe, Asia, and Africa to teach surgeons how to use them.

These implants offer a soft and supple feel with the added benefit of being relatively leak free due to the cohesion of the silicone. It is this consistency that allows the implants to maintain the commonly requested tear drop shape. While the edges of the implant blend gradually into the surrounding tissue, the thinner top of the implant slopes gently down to a fuller bottom half, creating the gorgeous contour of a natural breast. Studies show the lowest rate of capsular contracture and leakage with these implants of any implant ever studied.

If this sounds interesting to you, visit Dr. Teitelbaum's special website on cohesive implants, http//:www.cohesiveimplants.com. When you come in for your consultation, Dr. Teitelbaum will listen to you, assess your situation, and explain to you all the possible benefits and tradeoffs of these implants for you.

Does a virtually pain-free breast augmentation sound too good to be true?

Many of Dr. Teitelbaum's patients think it is - until they understand what he does differently and speak to actual patients who are pain-free just a day or two after surgery.

Recent developments really have allowed over 90% of our breast augmentation patients to return to normal activities within 24 hours, without the need for narcotics, pain pumps, special bandages, or bras.

Dr. Teitelbaum's patients routinely go out to dinner the night of surgery, go to Lakers games, or just enjoy the evening with their family. Most drive within several days, and need no more than a few days off of work.

Bruising is minimal or non-existent, and pain is controlled with just Advil.

When some surgeons hear this, they don't believe it! That's one reason why Dr. Teitelbaum teaches a course at the largest plastic surgery meeting in the world in which he describes how to do this.

How is it done? Meticulous preoperative planning assures not just that you will get the result that you want, but that time won't be wasted during surgery making decisions that could better have been made at leisure during your consultation before surgery..

Very careful surgical techniques coordinated with excellent anesthesia and a detailed understanding of fine points of anatomy, allow the operation to proceed smoothly and with a minimum of trauma. With our current anesthesia technique, it has been years since a breast augmentation patient has had significant nausea.

Because of rough or imprecise technique, some surgeons tightly bandage patients or make them wear a special bra in the hopes of forcing the implant into a particular position or to act as a tourniquet to prevent bleeding.. But Dr. Teitelbaum's precise and gentle surgical technique allows his patients to move their arms in the recovery room right after surgery! That way, your arms never get stiff and frozen. We hear stories that some doctors tell patients to keep their elbows at their sides "as if you had a broken arm" for many weeks after surgery. In contrast, we encourage our patients to shampoo and blow-dry their own hair the night of surgery.

The result is less pain, a shortened recovery, and a lower chance of hardening of your breasts.

Patients come to Dr. Teitelbaum from around the world for breast augmentation. Some come because of a satisfied friend, a magazine article, his reputation, or perhaps interest in a pain-free recovery.

But they often say this: Dr. Teitelbaum's photo book shows the best results they have seen anywhere. When you come in for your personalized consultation, you will be able to peruse literally hundreds of photos of women at all different stages of their recovery, and with literally every possible body type and implant choice. You will be stunned by the diversity of beautiful results!

Why does Dr. Teitelbaum have this reputation? While all surgeons give lip-service to creating natural results, Dr. Teitelbaum really means it. He pays attention to the many factors which contribute to creating a beautiful and natural result.

The single most important factor is the size and shape of the implant: too big looks bulgy and round and too small looks empty and bottom-heavy. Many surgeons determine implant size by having patients put rice or water in a bra. But doing so totally ignores the shape of your breasts! Dr. Teitelbaum takes multiple meticulous measurements that enable him to tell you the ideal size and shape for your breasts.

Patients who have gone on other consultations, often remark about the detailed analysis Dr. Teitelbaum makes of their breasts, noting subtle asymmetries, thickness of their tissues, and ratios of different measurements of their breasts. It is through this thoughtful analysis that he is able to make recommendations to make your breasts as beautiful as they can be.

In fact, he even is patenting a device to help other surgeons make the proper implant selection based upon each woman's breast.

He then discusses with you whether the implant that ideally fills your breast tissue creates a breast of the size that you want. He has a beautiful aesthetic eye, and he will discuss with you how well the ideal implant for your breast will fit in proportion to your body.

For a result to be beautiful, the breast implant must not sit too high or too low, and both sides must be even. Symmetry is a very important property of beauty. No matter what incision he uses, Dr. Teitelbaum always operates "under direct vision," so that he is precise and accurate in the placement of breast implants. Believe it or not, many surgeons still perform this operation "blindly," slipping a finger or an instrument through an incision to blindly create the pocket for the implant.

The appearance of a breast can be marred by a conspicuous scar. For that reason, Dr. Teitelbaum uses incisions that are well-hidden and inconspicuous, but that still allow for the creation of an accurate pocket and an easy recovery.

If you are considering breast augmentation for the first time, you want to be sure that you do it right. You obviously want to avoid the emotional distress, inconvenience, and expense of having to have an early revision. And doing it right the first time is the best chance to set you up for having a result that will be as long lasting and beautiful as possible.

There are many women with serious and even permanent problems because of errors made with their first breast augmentation. Dr. Teitelbaum has learned from these women which choices in the first surgery can set a patient up for problems later. Using these principles, he was asked by an implant manufacturer to create an educational curriculum to teach other surgeons how to reduce their revision rates. And he is coauthor on a landmark paper that sets guidelines for surgeons to reduce the number of operations a patient will have in her lifetime.

Many surgeons approach this surgery with a very short-sighted view of their outcomes. Dr Teitelbaum recognizes the importance of achieving beautiful results not just for a year or two after the surgery, but for a patient's entire life. While a surgeon that operates on a patient today is not technically responsible for a patient five years from now, Dr. Teitelbaum nonetheless recognizes that decisions made today will have effects years from now, and therefore counsels patients to make decisions that take this into account. He will always discuss with patients not just the short term effects of their choices, but what will happen to their breasts over time.

Other plastic surgeons refer Dr. Teitelbaum the most challenging cases that need revision. Having done so many of these revisions, Dr. Teitelbaum was asked to write a textbook chapter for an upcoming plastic surgery textbook entitled "Revision of Breast Augmentation."

As complex as first-time breast augmentation is, revision is substantially more difficult. Patients' anatomy may have been distorted with the past surgery, old records may have been lost, and tissues may have been thinned, stretched, or in other ways damaged. Worst, patients are frustrated, angry, and fearful after having spent a large sum of money and undergone one or more operations for a result that is totally unacceptable.

Dr. Teitelbaum understands these issues, and is aware of the spectrum of options to handle these problems, both "tried and true" and the new or experimental. For instance, he has a large experience using the cohesive or gummy bear implants, which can be helpful in many types of revisions because of their low likelihood of developing any visible folds or ripples. He is on the advisory board of a company named Lifecell which makes a special material derived from human or pig skin, working to find the optimal way to solve the most difficult augmentation problems. He is one of the pioneers of a new technique called the "neo retropectoral pocket," which is a powerful and very effective technique that can be frequently applied in breast augmentation revision. He has coauthored a paper on using it to correct symmastia (the so-called "uni-boob,") one of the most difficult problems to correct.

Capsular Contracture

This remains the most frequent cause for secondary reoperation. The best way to treat it is to avoid it in the first place. But if it occurs, it is important to take all the steps necessary to reduce its chance of recurrence. Complete removal of scar tissue, using a "low-bleed" implant, considering textured or cohesive implants, bloodless and gentle surgery, early post-op motion, and antibiotic irrigations are the cornerstones of treatment. Similarly, there are a few patients for whom recurrent contracture is unavoidable, and recognizing these situations and discussing whether or not to proceed is important as well.

Implant Malposition

The most beautiful women in the world all have asymmetry of their breasts. But sometimes an implant ends up so misplaced that it makes the asymmetry unacceptable and even causes deformities. The most common asymmetry is when one implant is too low. But they can be too close together, essentially joining in the center. This is known as symmastia (aka the uniboob deformity.) Or the implants can lay to far to the sides, widening cleavage and distressing patients by how far they fall out when they lay down. Treatment for all of these problems can be done by creating a new pocket. For instance, if an implant is in front of the muscle, a more even new pocket can be made behind the muscle, and vice versa. But if the pocket is already behind the muscle and there is good reason to stay behind the muscle, for instance to maintain good coverage over the implant, then one either closes off the lowered pocket with a technique called capsulorraphy or with something called a capsular flap. The newest way to handle this is with a technique called the neosubpectoral pocket, which creates a new pocket between the scar tissue and the muscle, using the strength of the scar tissue to correct the pocket malposition.

Droopiness

Sometimes an implant stays fixed in place and the breast can slide off it, drooping as a result of gravity. At other times, the implant itself falls down, stretching out the lower skin of the breast, which is known as "bottoming out." These problems most frequently occur in women who had large implants and/or pre-existing stretched skin and perhaps droopy breasts before they even had their implants. That could have been the result of their own development, weight fluctuations, or pregnancies. Very often, these patients will recall being told that they needed a lift when they first had their augmentation, but decided against it because they didn't want the scar. Each of these cases is very different, and care needs to be individualized.

Rippling/Visibility

Many patients complain that they can see or feel folds, ripples, or knuckles of implants. This happens mostly with saline, but it can even happen with silicone implants. If tissue is thin enough, this can even happen with the cohesive gel gummy bear implants, though that happens less frequently. Since he is an expert with the cohesive implants, many patients with this problem seek out Dr. Teitelbaum. While these implants do have an advantage over other implants for this situation, the underlying problem for most of these women is the thinness of their soft tissue over the implants. All of the patients with the worst rippling problems are extremely thin. The cornerstone of improving patients in this category is trying to get as much tissue coverage as possible, such as switching implants to behind the muscle if they are in front. Oftentimes, these patients have been behind the muscle, but they have stretched in the lower part of their breast, and by lifting the lower part of their breast, more of the implant can be kept under the muscle. Other techniques, such as using Strattice or Alloderm tissue implants can be very helpful in these challenging cases.

Size Change

This is an unfortunate reason for surgery. If there is adequate preoperative discussion and planning, this should be largely unavoidable, but it can still happen. Dr. Teitelbaum believes that implants should be sized at the first surgery according to what fits a patient's particular breasts. Too big will look unnatural and stretch the breast, and too small will leave the upper breast underfilled and the breast looking empty and disproportional. So, if the implant chosen for the first surgery is that which was suggested - on these objective terms - then to change the size later would be illogical. That being said, sometimes patients go larger or smaller than was suggested to them initially, or other patients change their mind about what they want. This operation is not always as simple as just removing one and replacing with a bigger or smaller size. It can require some work to increase or decrease the size of the pocket, depending upon your tissues and the change in size. The most important thing to recognize is that if you are wanting bigger and bigger implants because your skin has a tendency to stretch, you need to stop and consider whether you should stop and have a lift, rather than progressively going larger, which inevitably will mean more stretch and emptiness later…one step forward and two steps back.

Saline Problems

With the end of the 14 year moratorium on silicone in the United States ending in November of 2006, there are hundreds of thousands of saline patients in the United States who at one time or another will come in to have their implants replaced. Despite evidence demonstrating that the fears that lead to the moratorium in 1992 were unfounded, some women nonetheless are suspicious of silicone. But most of the patients Dr. Teitelbaum sees want to have silicone. Some saline patients are bothered by firmness and roundness if their saline implants were highly filled, while others are bothered by upper pole emptiness, sloshiness, and ripples if their implants were underfilled. With saline, there was no perfect fill, and switching to silicone frequently fixes these problems. Other women have a saline deflation, and come in after one breast "disappeared" over a few days, and have both implants switched, either to saline or to silicone. Many are coming in now years after their saline, asking now to either replace their saline implants or get silicone implants so that a deflation does not occur at a time that is inconvenient for them. Some women asking to switch to silicone have nothing really wrong, except perhaps wanting a little softer and more natural of a feel, and something that is less perceptible to their intimate partners.

Dr. Teitelbaum is pleased to announce new enrollment opportunities for patients interested in receiving the McGhan Style 410 implant.

Only about 30 surgeons participated in the initial FDA approved core clinical study of 960 patients, which took place in 2001 and 2002.

The FDA has recently approved enrollment of an additional 480 patients, to be completed over the next six months by an even more select group of surgeons.

Eligibility can only be determined after a thorough in-person history and physical examination and discussion. Interested patients should consider the following:

1. Dr. Teitelbaum will offer this only to patients who live in the Southern California Area. Contact Inamed directly if you live elsewhere and need the name of a participating surgeon.
2. Though this is a study, the usual breast augmentation charges apply. However, the company gives patients a stipend for completing their annual follow-up, which, after ten years, comes close to covering the cost of the device itself.
3. Patients must be absolutely committed to completing the annual follow-up visits.

Style 410 Breast Implants.

This implant has been sold in Europe since 1994, where it is now McGhan's most popular implant. It has the same outer shell as the McGhan 468, a textured teardrop shaped implant. But instead of being filled with saline, or with the usual liquid silicone gel, it is filled with a "cohesive" silicone gel, which is more like a soft solid. As a consequence, it is purported to not be able to leak, and to be much more resistant to developing folds or ripples than "non-cohesive" fillers, such as the typical silicone gel or saline.

What makes this implant different? The shell is McGhan's biocell textured shell, the same shell that McGhan has used for more than a decade, in a variety of both saline and silicone gel implants. The ingredients of the silicone gel filler are also identical to what McGhan has used for years in its silicone gel implants. What changes is only the ratio of ingredients in the mix, but the cohesive gel filler in the 410 involves no new compounds. What is different is that only a greater amount of "crosslinker" is used, which is essentially the catalyst that gives the desired degree of liquidiness or solidness to the gel.



The Style 410 Silicone-Filled Breast Implants were created by McGhan Medical to provide another shaped alternative to the round breast implant. These breast implants defy the one-shape fits all limitation associated with traditional round breast implants. Style 410 Silicone-Filled Breast Implants are available in an innovative combination of height, width, and projection options, ultimately resulting in the largest selection of uniquely different breast implants from which the plastic surgeon can choose. Each profile is available in a full range of sizes designed to accommodate a wide range of patient anatomies and personal preferences. The Style 410 represents a significant increase in shaped implant options in the McGhan Medical product line.



Notice how the implant augments the breasts naturally and proportionally, without any folds or ripples. The lower pole is augmented more than the upper, yet the upper is naturally projected, and the implant does not collapse.

	Style 410 Breast Implant with a wedge cut out of it, demonstrating how the CoheSIL® silicone gel fill does not leak.
	Even under substantial pressure, the CoheSIL® silicone gel fill does not leak.
	Corner of a Style 410 Breast Implant being squeezed.
	After pressure is released, the silicone gel fill returns to its normal shape.
	The shell of the 410 is the same "textured biocell" durable shell that McGhan has used for years. Here it is shown held flat, after being cut away from an implant.
	Even under this great stress, the shell remains pliable and intact.

The CoheSIL® gel fill used in the Style 410 improves the ability to design and manufacture shaped breast implants. The cohesive nature of the Cohesil® gel fill serves to maintain implant shape with a single lumen construction. The potential for reduced silicone migration of Cohesil® gel in the event of implant rupture remains to be established.



As already shown, the shell is extremely strong and resistant to damage. But here, it is actually shown in the artificial condition of having been totally stripped of its shell. It maintains its shape, sitting upright like a peeled jelly bean, with the implant gel remaining undistorted, neither rippling, folding, nor running. This is the result of the "cohesive filler."

Participation in the study will require the patient to make annual office visits for ten years. Limited compensation will be provided for each scheduled office visit. Compensation from McGhan will be $100.00 per visit, increasing gradually to $200.00 for the 10TH year visit. All other fees, including the services of the plastic surgeon and products, are the responsibility of the patients participating in the study.

Summary of 410 Style Breast Implant design innovations:

• The CoheSIL™ silicone fill is more cohesive than standard silicone gel fills.
• McGhan Medical Style 410 Breast Implants consist of CoheSIL™ silicone fill encased in a silicone elastomer shell. The shell features the BIOCELL® textured surface and INTRASHIEL® barrier.
• The CoheSIL™ silicone fill is more cohesive than standard silicone gel fills;
• The BIOCELL® textured surface is designed to promote tissue adherence which helps maintain the proper position within the surgical pocket, and may reduce capsular contracture;
• The INTRASHIEL® shell features a patented design to minimize silicone diffusion;
• Choice of uniquely different breast implant configurations provide the capability for the plastic surgeon to optimize aesthetic results.

ConfidencePlus™ Breast Implant Replacement Program

The McGhan Medical ConfidencePlus™ Breast Implant Replacement Program applies to all McGhan breast implants sold and implanted in the United States, including the new 410 Style Breast Implants. ConfidencePlus™ provides lifetime replacement and limited financial reimbursement in the event of loss of product integrity, subject to certain conditions as fully discussed in the ConfidencePlus™ literature. For more information, please contact the McGhan Medical Customer Affairs Department at 800.624.4261.

Contact us at 310.315.1121 for more information about the Style 410 Breast Implants Study.

Patients in Southern California have many plastic surgeons to choose from. Selecting between them is not always easy. The surgeon that may be right for one woman may not be right for another. You need to find a surgeon whose philosophy, expertise, and approach to breast augmentation meshes well with your own feelings.

The following summarizes what Dr. Teitelbaum considers to be the distinguishing aspects of his approach to breast augmentation. Dr. Teitelbaum truly only wants to operate on patients whose philosophy about breast augmentation is in sync with his. You are invited to consider these issues and discuss them at your consultation.

1. Patient Education. Far too often, patients are told by the surgeon what to do without really listening to the patient. Others do whatever the patient asks without adequately informing the patient of the tradeoffs. Dr. Teitelbaum believes in doing what the patient wants, but ONLY after she has been fully informed of the consequences of each of her choices.
   
2. Quantitative Tissue Assessment. Most surgeons make decisions about breast augmentation based upon hunches, impressions, gut-feelings, and gestalt. These are notoriously inaccurate. Dr. Teitelbaum measures a patient’s breasts very carefully, and formulates a plan based upon her body. This allows him to select and implant that will fit within her breasts, without stretching or distorting them. The consequence is more natural results that last over a longer period of time. He specifically avoids operating on patients who request fake, unnatural, or “Baywatch” appearing breasts.
   
3. Natural Results. Plastic Surgeons’ practices evolve over time. Some doctors treat a lot of porn stars; Dr. Teitelbaum does not. Nearly all of his patients ask to “look natural.” In fact, they are afraid of looking fake and often put off getting an augmentation for fear that “you can always tell” (which you usually can’t if it is done right.) Most of the patients Dr. Teitelbaum sees are not the sort to worry that they will be big enough and “get their money’s worth,” but are concerned about looking natural and proportional and not doing anything to their breast tissue that will cause long term damage. By assessing your breast quantitatively, Dr. Teitelbaum will determine the implant that will fit in you, which means no upper bulging, minimal implant visibility and palpability. Your breast envelope will be filled but not stretched.
   
4. Knowing what to expect. Patients considering augmentation are always nervous about how big they will be after surgery. He will measure you to determine the optimal size for your tissues. He will give you a sizer of an implant to put in your bra so that you will know roughly what to expect. If you want to be bigger or smaller than he suggests from his measurements, then you can discuss that, and you can choose to go bigger or smaller. But he will explain to you the consequences of varying; going larger may mean more upper fullness and ability to see the implant, and going smaller may mean that the upper breast does not get filled out. He will explain this to you so that you will not wake up from surgery surprised at your size or shape.
   
5. Rapid Recovery. Breast augmentation can be done today so that most patients experience little discomfort after surgery. Most can shower and blow dry their hair themselves the night of surgery. Though individual response to pain can vary, stories about patients suffering severe pain or being unable to move their arms for days after surgery does not happen with the way Dr. Teitelbaum does the procedure. Expect to not need narcotics and feel well enough to leave the house for dinner your night of surgery. Dr. Teitelbaum’s patients do not need to use special bras, pain pumps, or bandages.
   
6. Choice. Dr. Teitelbaum offers patients a choice of all implant types approved by the FDA as well as all implants undergoing FDA clinical trials. No other plastic surgeon in California can say that. You will have your choice of incision and location of the implant relative to the pectoralis muscle. Breast augmentation consists of making a series of imperfect choices. Each has its own benefit and reward, and Dr. Teitelbaum will discuss these with you.
   
7. Minimizing reoperations. All augmentation patients should expect to have another breast operation at some point in the future. Dr. Teitelbaum’s goal is to put that off as long into the future as possible. He views augmentation as an entirely elective, even frivolous operation. For that reason, he believes an extra level of care must be devoted to trying to get it right the first time. While he cannot guarantee that for all patients, by carefully selecting the proper size ahead of time –rather than subjectively and inaccurately sizing an implant intraoperatively – he can nearly eliminate reoperations for size. He employs every technique that has been shown to reduce capsular contracture. Though contracture can still occur, he will take every step to reduce the likelihood of its occurrence. He has written on this subject and lectures about it frequently, so it is an issue for which he places great emphasis.
   
8. Post-operative Care. Dr. Teitelbaum does not just operate on you and send you on your way. He will see you the day after surgery, the next week, and at frequent intervals. He never charges for a follow-up visit, and encourages you to return as often as you ever have a question or concern.
   
9. Teacher of other surgeons. It is often said a surgeon doesn’t ever really understand an operation until he teaches it to someone else, and that is certainly true for breast augmentation. Dr. Teitelbaum doesn’t just enjoy teaching residents and other plastic surgeons about breast augmentation, but has found that the more he has done this, the more it has forced a refining of his own understanding of the operation, resulting in a progressively better experience for his patients. He gives the course on breast augmentation taught at the largest aesthetic surgery meeting the world, and has lectured on breast augmentation to other surgeons around the world.
   
10. Experience with various implants. In addition to saline implants, Dr. Teitelbaum has extensive experience with every silicone implant on the market in the USA today. He even has experience with the next generation of implants that are now “in the approval pipeline”, having been a clinical investigator on the experimental trials of those implants in the United States. He has among the most diverse and in-depth experience with these implants of any surgeon in the United States.
11. He will tell you the truth, not necessarily what you might want to hear. Plastic surgery is a business like any other; plastic surgeons make money by operating. While most are highly ethical and straightforward, some will say what is necessary to schedule a patient for surgery. Dr. Teitelbaum will tell you what he believes to be true. For instance, patients often bring in photographs of models that they want to look like. It would be easy enough to just say to each patient, “Yes, this is what you will look like,” but Dr. Teitelbaum will answer your questions honestly, and sometimes even bluntly. He frequently advices patients not to have surgery, such as patients that are already relatively large with nice shape in whom he does not think the benefits of surgery justifies the risks, or patients who seem to envision a result that cannot be attained with their body.

Dr. Teitelbaum has an international reputation for breast augmentation surgery. He is up to date with the very latest developments in breast augmentation surgery and implant technology from his extensive traveling to lecture at meetings, teaching courses, consulting to industry, and from his large clinical experience. He is also an author of articles and book chapters on the subject of breast augmentation.

He has significant experience using all of the implants now available. He was a participant in the standard silicone gel trials for over for ten years, which allowed him to use the very same silicone implants that gained FDA approval in the Fall of 2006. He has used them hundreds of times in a wide variety of clinical situations, including primary augmentation, revision of previous silicone and saline augmentation, augmentation with a breast lift, and treatment of uneven or deformed breasts.

He also has one of the largest clinical experiences in the United States with the next generation of breast implants, best known as the "gummy bear" implants. Both domestic manufacturers (Mentor and Allergan) and a Brazilian manufacturer (Silimed) each selected an elite group of surgeons to carry out their clinical trials. To generate the best data, the manufacturers hand-picked the participating doctors. It was enviable to be selected for just one of the trials, but Dr. Teitelbaum is the only plastic surgeon in California –and perhaps even in all the USA - to have participated in all three.

In one recent year, Dr. Teitelbaum lectured to surgeons about breast implants on five continents (his hopes of doing all seven continents were dashed when his Australia trip was canceled and there was no meeting scheduled in Greenland that year!) He has lectured in places as varied as Brazil, Sweden, England, Mexico Morocco, Israel, and throughout the United States.

Dr. Teitelbaum instructs the course given on breast augmentation at the annual meeting of the American Society of Aesthetic Plastic Surgery, the largest aesthetic plastic surgery meeting in the world. This course has been videotaped and is sold to surgeons around the world. He is on the guest faculty at UCLA Medical School, where he is an attending surgeon at the resident's clinic and operating rooms, teaching how to evaluate breast augmentation patient and how to perform a breast augmentation.

One of the major implant manufacturers has hired Dr. Teitelbaum to develop their educational materials for other plastic surgeons. He advises them on how to describe the advantages and disadvantages of their various implants to patients and surgeons. He is therefore aware of the subtle differences between implants currently available, as well as implants that are currently under development.

Dr Teitelbaum became involved in teaching other surgeons because he has always been committed to educating himself. He visited the most respected breast surgeons around the world and learned from them. It was only after he brought what he learned from them and put it to use in his own practice and developed in his own thinking that he too became a leader. Other surgeons now visit him and seek his advice on complicated breast surgery. But he continues to learn from other surgeons –as well as his patients – and is devoted to continually improve his patients' experiences.

Last week, a 41-year-old woman who had recently had her first child walked into the office of Dr. Steven Teitelbaum in Santa Monica, Calif., for an operation that tens of thousands of women like her have undergone this year: a breast lift.

“I didn’t like the way they looked,” said the woman, Jennifer, who asked that her full name not be used because she wanted to keep her medical procedures private. “And it’s the best money I ever spent.”

But the bill for the kind of operation Jennifer had — and other procedures to combat crow’s feet, beer bellies and sags of other sorts — could also soon be higher under a 5 percent tax included in the health care bill being debated in the Senate.

The tax, which would be paid by the customer but collected by doctors, would be levied on any cosmetic surgery that is not necessary to address deformities arising from congenital abnormalities, personal injuries resulting from an accident or trauma, or disfiguring diseases, a definition taken directly from current tax code covering deductible medical expenses.

The proposal — called the Bo-Tax, in a play on the name of Botox, the popular wrinkle-eliminating treatment — has outraged plastic surgeons, who say they are being singled out because of an outdated perception that people who have cosmetic procedures are well-to-do.

The 7,000-member American Society of Plastic Surgeons said its internal surveys showed that 60 percent of members’ patients earn less than $90,000 a year.

“A lot of people think of this as a tax on rich Republican housewives; rich, nonworking Republican housewives,” said Dr. Phil Haeck, the group’s president-elect. “And that’s not the case.”

Whatever their pay grade, Americans seem to have a growing appetite for nips and tucks. According to the society, there were more than 12 million cosmetic procedures in 2008, up 3 percent from the year before, though the recession was blamed for double-digit declines in liposuction and tummy-tuck procedures. (Belt tightening, it seems, is not good for belt tightening.)

A tax might exacerbate those declines, said Dr. Haeck, who also raised the possibility that more patients might travel to other countries for procedures, which he said often cost less and might not be as safe.

“Maybe if you live in a border state, maybe you’ll find it more appealing to go to Mexico,” Dr. Haeck said. He added that in places like Thailand, procedures can cost one-fifth of what they do in the United States. “I’m not sure if it will drive medical tourism harder and faster, but I shudder to think what we’ll see if that practice is enhanced by the surgery tax.”

Dr. Teitelbaum, the Santa Monica surgeon, seconded that opinion, and called the proposed tax “cowardly.”

“You’re taxing a disorganized group that has no one of its own representing it,” he said. “There’s no American Society of Plastic Surgery Patients.”

Dr. Teitelbaum said some patients might be embarrassed to admit to having had cosmetic surgery. “They don’t want to come out and march on Capitol Hill,” he said. “You’re not going to have a million-man Botox march.”

Another argument made by some groups is that the tax would be discriminatory toward women, who make up a vast majority of cosmetic surgery patients.

Terry O’Neill, the president of the National Organization for Women, said middle-age women, who make up a bulk of her group’s financers, would be particularly susceptible to the tax, especially now. Many who have lost jobs might be considering surgery, she said, because they are looking to impress potential employers.

“They have to find work,” Ms. O’Neill said. “And they are going for Botox or going for eye work, because the fact is we live in a society that punishes women for getting older.”

Ms. O’Neill said women commonly pay higher health insurance premiums and suffer wage discrepancies from men. “And now they are going to put a tax on middle-aged women in a society that devalues them for being middle aged?” she said.

Jim Manley, a spokesman for the Senate majority leader, Harry Reid, Democrat of Nevada and a supporter of the tax, said that the motivation was purely economic.

“We needed money to make the bill work,” Mr. Manley said in an e-mail message, adding that such cosmetic surgery taxes had been raised in the past by the Finance Committee. “Also, we wanted to stay within the health care arena.”

Doctors say that the line between elective and necessary is often blurry. For her part, Jennifer, the 41-year-old patient, said her pregnancy had left her with an exceedingly large bosom, something that was both unflattering and uncomfortable.

“I’m not a Hollywood, Santa Monica type that has to have everything done,” she said. “It was a big deal even to consider it.”

She paid $8,000 for her breast lift, and said that a 5 percent tax would not have dissuaded her from having the operation.

And while she said she was economically comfortable — as a human resources executive, she said, she makes $250,000 a year — she said she thought her new figure might solve another problem.

“I’m single,” she said. “But now I’m not going to be.”

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