The Allergan Natrelle 410 highly cohesive silicone gel ("Gummy bear") implant
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 implant holds its shape, unlike a round implant 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 standard 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.
In November, 2006, the FDA approved round silicone 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 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 gel implant. There are times, however, when you want the 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 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 tradeoffs, 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.
Now comes the Allergan 410
Now enter the Allergan 410 form-stable teardrop shaped “Gummy-bear” implant. 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 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 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.
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. 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 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 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.
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 that allow the surgeon to select a device that best suits the desires and tissue characteristics of the patient. 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. Round smooth alternatives include the Inspira 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.