DR. EPSTEIN’S COMPREHENSIVE Breast Augmentation Guide

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The Allergan Natrelle 410 Highly Cohesive Silicone Gel (“Gummy Bear”) Implant – Why Did I Use Them?

NOTE: Due To Concerns Regarding ALCL, This Implant Is No Longer Available. I Have Left The Below Content On This Website For Those Are Interested Historically As To Why I Did Use Them.

What is the Allergan 410 implant?

The Allergan 410 implant is an anatomical (or teardrop, breast shaped) implant that contains a highly cohesive silicone gel that is form-stable. This highly cohesive gel that holds its shape is also nicknamed “Gummy”, after the candy “gummy bears.” This implant holds its shape, unlike a round implant filled with less cohesive gel which is not form-stable. It is not the shell of the implant that gives it its unique shape, but rather the distribution of the highly cohesive gel within the implant that gives it shape. To achieve its unique shape, the gel does need to be firmer than a non-gummy silicone gel implant. There is a tradeoff here: the more the implant holds its shape and resists shell folding, the firmer the gel needs to be. As stated above, it is important to realize that different manufacturers of cohesive gel implants use silicone gels of differing firmness. It has been in use around the world for well over twenty years as well as in clinical trials in the United States for approximately 12 years, and several hundred thousand women around the world have these implants. In February, 2013, the Food and Drug Administration (FDA) gave approval to the Allergan 410 implant for use in this country. Prior to having access to this implant, surgeons must be trained and certified to use it by Allergan. These implants are the most extensively studied breast implant ever.

Historical Information

In November, 2006, the FDA approved round silicone “non-gummy” gel filled implants for use. This was a game changer. Silicone is a cohesive filler, and saline is a non-cohesive filler. The shell, or bag of both types of implants is still made of a thin, silicone material, but unlike a saline implant, a silicone gel implant is filled with silicone gel rather than saline. A cohesive substance sticks together – a gel is cohesive in nature. A non-cohesive substance doesn’t stick together. Saline is essentially salt water. Drop water on the flow and it runs everywhere. Drop silicone gel on the floor and it sticks together in one gelatinous mound. So, what is the difference? A bag filled with a non-cohesive filler like saline will be much firmer to the touch than a bag filled with a cohesive substance like silicone. The result – a breast that feels much softer to the touch, more like human breast tissue than a bag of water! Furthermore, because silicone implants are by nature so much softer than saline implants, the breast shape with a round silicone “non-gummy” gel implant was not bad at all! It was like the breast tended to give a silicone implant its shape where as a saline implant tended to force its shape upon the breast. So, over a thousand implants later, my patients and I are very happy with the softer feel and look of a breast with a round silicone “non-gummy” gel implant. There are times, however, when you want the softer feel of a silicone gel implant, yet also influence the shape of the breast and that is just what the Allergan 410 silicone implant will do. It is firmer than a conventional silicone gel “non-gummy” implant, softer than a saline implant, and better retains its natural shape. In breast augmentation, just like there is no perfect breast with perfect tissues, there is also no perfect implant. It’s all about understanding the advantages and disadvantages of each device, assessing the patient’s tissues and deciding based upon understanding how each device will behave within a given type of breast tissue. There are always some trade-offs, and therefore it is so important to really take the time to understand these issues for yourself and consult with an experienced breast augmentation surgeon.

Why do I keep using the term “Non-Gummy”?

In 2006, when the FDA re-approved silicone gel implants, we did not call them “non-gummy.” We only had one type of silicone gel and that’s what we called it, a “silicone gel implant.” This is analogous to the first world war. No one referred to it as World War “I” until the second world war. So to distinguish the two wars, they were called World War I and World War II. Back to silicone gel implants. The new generation of silicone gel implants were applauded when they appeared on the market in 2006. They were soft and squishy, like a human breast. Actually, more squishy than a human breast, but when you were used to using only very firm saline implants, this was an incredible leap forward. While these implants gave rise to a very nice shape and natural feeling breast, the gel tended to stay at the bottom of the implant, resulting in loss of upper breast fill. This was especially true in more lax breasts, such as those that have lactated or resulted from weight loss or aging. This was the downside of the new “non-gummy” implants.

Now Comes The Allergan 410

Now enter the Allergan 410 form-stable teardrop shaped “Gummy-bear” implant. The Allergan 410 contained a new type of gel. It was firmer so that it held its shape, which was now teardrop. This increase in firmness, which gave the implant its “form-stability”, that is the ability to retain its shape, was due to the characteristics of the silicone gel, which we now refer to as “gummy”. We did not have round gummy implants at this time, although they were available in Europe. Everyone seems to think that the purpose of this implant is to prevent leaking. If the implant shell is compromised (tears), the gel will not come out. This is partly true, but this is not the purpose of the implant. When compared to a typical silicone “non-gummy” gel implant, if the shell breaks, the gel will still come out of the shell, perhaps at a much slower rate. In either case, the gel is still contained within the scar capsule that forms around every breast implant starting just a few weeks after surgery. Silicone gel is inert anyway, that it doesn’t react with the body and vice-versa, therefore it is non-toxic. The real benefit, the real beauty of this implant is that it gives the breast the best possible shape and maintains that shape years longer than a standard silicone gel implant. Isn’t that what a woman would want anyway?

About The Textured Surface

All shaped implants must have a textured surface. They are not available with a smooth surface. The textured surface adheres to the surrounding tissue (like Velcro), unlike a smooth surface which does not. This is essential so that the implant is held in place and doesn’t move or turn out of position.  Round implants are available with both smooth and textured surfaces. The selection of one or the other is up to the surgeon’s personal preference. Different manufacturers of breast implants use different textured surfaces. It has been noted that the rates of ALCL vary among manufacturers, with Allergan textured surface (Biocell) implants being associated with the highest rate of ALCL. (Remember, it is the textured surface of the implant, be it saline or silicone gel filled that is at issue with ALCL. The silicone implant shell as well as silicone gel filling inside have nothing to do with ALCL.) Does that mean that something was done improperly or incorrectly? In my personal opinion, the answer is a resounding NO! The Allergan textured implants are probably associated with higher rates of ALCL because this textured surface does the best job of doing what it is supposed to do – creating a surface that best promotes tissue ingrowth. This means that the “nooks and crannys”, like an english muffin” must be numerous and deep enough to allow this ingrowth. It is felt that in some rare cases, the textured surface which allows the implant to adhere to the chest wall and breast tissue, and possibly reduce the risk of capsule contracture in some cases, may allow certain types of bacteria such as Ralstonia Pickettii to adhere to the implant, protected from the body’s immune defense system by a thin biofilm that forms around the implant shortly after insertion into the breast pocket during surgery.  These bacteria set up a chronic inflammatory condition which after several years causes a transformation of cells in the scar tissue capsule that forms around all breast implants into a rare type of malignancy called Anaplastic Large Cell Lymphoma (ALCL). The incidence of this varies, but it is a very rare condition. ALCL is very curable with just surgery to remove the implants, the scar tissue and then round smooth implants can be placed at the same time. When detected early, there is no need for chemotherapy nor radiation, and there is expectation for survival.The average duration of time from implantation to the development of ALCL is about nine years.

A little more about firmness of the breast…

Younger patients, particularly those that have not yet become pregnant have firmer breast tissue, so for these patients, a more cohesive breast implant like the Allergan 410 may not be at all an issue. For those with more compromised tissue such as those that have lactated, or perhaps lost a significant amount of weight, an implant like the Allergan 410 may represent more of a change from what they are already accustomed to. Firm breasts are closer to the aesthetic goals that most women are trying to achieve. If you want to minimize rippling, want an implant less prone to breakage and silicone leakage, and want a shape that lasts, then you must accept the additional firmness of a form stable implant like the Allergan 410.

My Opinion on the Allergan 410

Currently, there is a lot of controversy about this implant. Breast augmentations with this implant gave wonderful, stable results. It was particularly well suited for those with tubular breasts and those with very little breast tissue to start with. Fortunately, there are now several other alternative round smooth implants with varying degrees of softness and form stability (“gummy round implants”) that allow the surgeon to select a device that best suits the desires and tissue characteristics of the patient. The more form-stable, round “gummy” implants are a wonderful alternative to the Allergan 410 textured teardrop silicone gel form stable implants. As of this writing, there are no known cases of ALCL associated with round smooth implants.

On 7/24/2019, Allergan voluntarily recalled the 410 implants. Available round smooth alternatives include the Inspira Responsive “non-gummy” , Soft Touch “gummy” and Highly Cohesive “gummy” implants. These implants vary in softness and ability to retain their shape, permitting a level of customization previously not available in breast augmentation.

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