Greetings to all. There is a new breast implant that has been FDA approved. Well, it’s not entirely new since it has already been in closed clinical trials for about 10 years. It is the Allergan Natrelle 410 highly cohesive shaped breast implant. This is the one that was originally coined the “gummy bear” implant. It is a welcomed addition to the selection of available breast implants. As I will explain however it has a smaller very defined audience. Most breast implants to date have been round in shape. This is the “standard” that we have all used for years. These round implants are made of an outer container, the shell, of silicone and are then filled with either silicone gel or saline (salt water). In the 90’s, when a moratorium occurred restricting the use of silicone gel implants, anatomically, or tear drop, shaped saline implants were developed. These are still in use today. I generally use them in women who prefer saline, and are narrow chested and desire a full projecting result. Also in the 90’s shaped silicone gel implants were used. I used many of these especially in breast reconstruction after mastectomy. These were basically taken off the market when the implant companies had to submit their implants for FDA approval, and their attention was focused on just getting the standard round implants approved. So where am I going with this you may ask?
In spite of the great success of the round implant, there has always been a search for an implant that could really “shape” a woman’s breast, without just “making it bigger”. Enter the Natrelle 410 implant. The 410 still has an outer container of silicone. But it is filled with a “highly cohesive” silicone gel. Many years ago the silicone gel had a consistency of molasses. This type of gel was able to leak out from the implant container and, especially if the implant had broken, could get out into the actual breast tissue itself. Highly cohesive gel has the consistency more like sticky Jello. This makes it much less likely that any of the gel can get into the breast tissue and cause trouble. All silicone gel implants today are filled with cohesive gel. The Natrelle 410 takes it one step further. This gel is so cohesive that it will maintain it’s breast like shape even after placed into position. So what does all this really mean in practical terms?
Many women have very little breast tissue, either as they develop (or fail to develop) or after pregnancy and/or breast feeding. Many of these women desire to have their breasts enhanced but do not want the roundness that often comes from standard round implants. The 410 is designed specifically for this. There is not a right or wrong with this and many women prefer to have a little more fullness, or roundness, in the upper part of their breast. The advantage of the 410 is that it can shape the breast predictably and have reduced risks of irregularities, wrinkles, and ripples, which were common in previous types of shaped gel implants. Up till now they have only been available in closed clinical trials. In February 2013 the FDA approved the general use of these implants after examination of 7 years of safety data that was presented. While there are still “issues” with any implant, such as rupture, capsule contracture, and malposition, these implants were determined to have a high safety profile.
So what are the downsides? The implants are designed with specific dimensions of “natural” appearing breasts. These dimensions may not fit every woman’s own ideas of what they consider either natural, or more attractive. The the implants are chosen to fit very close to the woman’s own physical dimensions and cannot really be exceeded. This generally means that the result of the surgery might not be as large as a woman might want. Also, the implants are more firm than standard round gel implants because of the very nature of having a “shaped” implants that doesn’t change. This also may not be what a woman favors. Finally, if the implants turns ever so slightly, it could be noticeable, again because it is a shaped implant and not round. All of these issues must be discussed thoroughly in deciding which implant is right for each woman. Finally the cost for these implants will be significantly more. While more choice is always welcomed it always comes with more information to understand and consider before choosing which implant to use.
Anyway, I hope this helps to summarize “what’s new”. Feel free to comments or send in questions. Looking forward to warm weather.