The 410 breast implant was approved for sale in the United States in February 2013.
The Allergan Natrelle® Style 410 Breast Implant
“The 410″ is the breast implant that started the entire field of cohesive breast implants. Depending upon whom you speak to, every other gummy bear implant is either an imitation of the Natrelle® 410 or an improvement. In either case, the 410 remains the most popular gummy bear implant throughout the globe.
It was initially designed in 1989, but by the time it was ready to go to market in 1992, the FDA placed a moratorium on all silicone implants. In the meantime, the 410 became a popular implant worldwide, following its global launch in 1993. The FDA reapproved silicone breast implants for general use in 2006, but since the 410 was technically considered a different implant, it was subject to a different approval by the FDA, which occurred in February of 2013.
The clinical trial of the Style 410 breast implant began in the spring of 2001, so there is now a substantial amount of long term data. In all categories – rupture, malposition, hardening, etc – the Allergan 410 demonstrates objectively better data than any of the implants that were approved in 2006.
Much is made about the highly cohesive gummy bear nature of its silicone filler. It should be noted that the ingredients of it are not different than less cohesive silicone gel implants. It just has more “cross-linker” added to it, which makes the usually gelatinous silicone gel firmer than usual. It is also cured and allowed to dry with a different process than standard silicone gel breast implants.
The 410 is unique in that it is probably the most specifically researched and written about implant. There have been many international symposia devoted exclusively to the use of the Natrelle® 410 breast implant. No other gummy bear implant has had such attention devoted to it.
Another interesting fact about the Style 410 breast implant is that the process necessary to effectively use the Allergan 410 for breast augmentation gave rise to the most important recent developments in breast augmentation. For instance, selecting the ideal size and shape of a gummy bear implant is critical because unlike a standard silicone implant, its form stable nature means that it will not distort according to the shape of the breast; rather, it will shape the breast. This means that the right shape is important. Size and shape selection systems that are the state of the art today were based on selecting the right implant.
Proper use of the 410 and any anatomic breast implant requires the surgeon to make a pocket that exactly fits the implant, because if it is too big and loose the implant will rotate; if it is too small the implant will not sit flat. These technical refinements resulted in a faster and more exact operation, which results in a quicker and less painful recovery. Today’s leading surgeons can create these results with any implant, but it is indeed interesting to note that these advances came out of the 410.
The Style 410 comes in 12 shapes for any given volume, combining different ratios of width, height, and projection. There are four different projections and three different heights. The projections are low, moderate, full, and extra. The heights are low, medium, and full. The original implant was an FM, which is full height, moderate projection. Another popular implant is the MM, which stands for medium height, moderate projection. These two anatomic shapes are the most commonly used shapes for the overwhelming majority of breast augmentations. The low height, low projection, and full and extra projection implants are more frequently used for breast reconstruction or for augmentation patients with significant asymmetry or deformity.
The Allergan 410 is the firmest of the gummy bear implants. Advocates say that such firmness is necessary for a gummy bear implant to work as it was intended. Because if it were much softer, it would lose its shape and durability, and risk creating the folds it was intended to avoid. Others prioritize softness. In reality, the implant is only slightly firm. It certainly is not hard. Patients with firm breasts typically like the feel of them. The only patients who appear to consider them firm are patients with more loose and pendulous breasts, probably because their breast tissue is itself very soft than the implant.
Both the Mentor CPG and the Sientra breast implants are a bit softer than the Style 410. Some patients and surgeons may prefer that, but it is unclear whether the CPG and the Sientra implants actually feel different in the patient. It is also not clear that the 410 maintains its shape in the body any better than the CPG or the Sientra maintain their shape.
In Europe there is a second version of the 410 called the 410 Soft Touch. It is the same shape as the standard 410, but it is made with a softer gel. Advocates like that it is softer, but others think that the implant is so soft that it is no longer form stable, which means that the surgeon does not have as much control over the breast shape. It also means that there may be more of a tendency to folds.
One of the features of the 410 is not just that it has so many shapes, but that the most common shapes, the MM and the FM have such a nice shape. The edges are thinner than some of the other gummy bear implants, particularly the Mentor CPG. This may allow for more gradual contouring and a more natural appearance. The maximal projection of the implants is low, which beautifully fills the lower breast and ideally projects the nipple forwards and with a slight upward tilt.
The 410 has the most aggressive texturing of all of the implants. Allergan calls this surface Biocell™. It is a highly three-dimensional structure. Biocell™ is made by pressing special salt crystals against the implant shell while it is still wet and curing. The salt is then dissolved away, leaving three-dimensional interstices. Advocates of Biocell™ believe it is the most effective at reducing capsular contracture of all surfaces, and that the friction and perhaps tissue ingrowth that occurs with Biocell™ reduces the chances of rotation.
The 410 probably has more loyal physician advocates than any other single breast implant in the world.
The shell plays a very important role in the function of the Natrelle® 410 breast implant. The shell has a special layer within it that reduces the amount of microscopic gel diffusion through the shell. This microscopic leakage can cause inflammation and scar tissue formation around the implant. The rough surface also helps hold the implant in its proper position. Finally, it is extremely thick and durable, making it highly resistant – though not immune – from breakage.
This is a Style 410 breast implant with its shell totally peeled off. Note how it almost perfectly maintains its intended shape. If the gel were too soft, it would not hold its shape. This also demonstrates why the implant is much less likely to form folds than less cohesive implants.
Despite strong pressure and a corner of the 410 implant cut away, the highly cohesive gel does not pour out of the implant. Some people will say that a gummy bear implant cannot break or leak, and that is not true. It occurs less frequently than with other implants, but the temperature and fluid inside of the body can allow some migration of silicone gel, though such migration is not presumed to be harmful. That is very uncommon, but it is still important for everyone to realize that neither the 410 or any implant currently made is free from any chance of breakage and leakage.
With pressure relived from the implant after being maximally pressed down, the Natrelle® 410 breast implant returns to its shape. This is why it is the ultimate gummy bear implant. It is soft, yet it is still able to hold a shape.
On the left is a 410 and on the right is a highly cohesive round implant, a type that is not available at all in the Untied States. Notice the teardrop shape of the anatomic Style 410, and how the cohesive round still looks round. Notice the gradual slope at the top of the 410; that helps the 410 to blend softly into the surrounding tissues, giving a more natural appearance.
On the left is a 410 and on the right is a Sientra gummy bear breast implant. Note the more pronounced point of maximal projection on the 410, and the more tapered upper pole, making the end of the implant less abrupt. Note how the Sientra is fatter at the top and more blunt along its forward surface. You can also see little undulations in the surface of the Sientra as a result of its somewhat softer silicone gel.
On the left is a 410 and on the right is the Sientra. Note how the 410 shape is mostly unchanged from how it looked when the implant was laying flat. It is also smooth, without any folding. But the Sientra has buckled a bit. You could imagine feeling the buckling if a patient had very thin tissue. Sientra advocates would argue that the Sientra feels softer; its detractors would say that the gel is not firm enough to maintain the implant’s shape.