Introduction of the Natrelle® Anatomically Shaped Breast Implant
The Natrelle® 410 anatomically shaped highly cohesive silicone gel-filled breast implant was approved for use in breast augmentation, breast revision, and breast reconstruction surgery on February 20, 2013. The Natrelle® 410 provides an alternative to traditional round implants for women considering breast enhancement surgeries.
The Natrelle® 410 highly cohesive anatomically shaped silicone gel breast implant is a fifth generation device that can be considered the ‘next generation’ for breast augmentation, reconstruction, and revision surgery. It is the number one anatomically shaped gel implant world wide, and has been available in Canada since 2006 and Europe since 1993. There are more journal publications and other peer-reviewed data regarding The Natrelle® 410 than any other shaped silicone gel breast implant.
The anatomic shape of the Natrelle® 410 implant is designed to mimic the natural slope and projection of the breast. This breast implant is filled with a highly cohesive silicone gel, which allows the implant to hold its shape over time, but still feels soft to touch. From a surgeon’s standpoint, the ability of the 410 to maintain projection in the lower pole, as well as a gentle slope in the upper pole, produces predictable and consistent outcomes. The 410 is available in a matrix of size and shape options that gives surgeons the opportunity to provide a more individualized approach to planning and aesthetic outcome.
Differences Between Round Implants and the Natrelle® 410
For many women, round silicone and saline breast implants are good options, and they will remain so. For others, round implants may not provide the aesthetic results certain women desire; the 410 will help these individuals obtain the look they want.
It is important to understand that the 410 is not suitable for every patient. It is better suited for women that have a tight-to-average compliance of their breast-skin envelope. The 410 will not work well for those women who have more significant breast drooping and ptosis.
The gel filling of the Natrelle® 410 differs from that of round gel implants. The Natrelle® 410 is filled with a highly cohesive silicone gel. A round gel implant is filled with only moderately cohesive (also termed ‘responsive’) silicone gel. This is a very important difference. The highly cohesive silicone gel in the 410 controls implant height and projection. This very specific gel distribution within the shell provides ‘form stability’ to the implant shape, and thus ultimately to the breast shape. The stability of the implant shape, even when in an upright position, allows the Natrelle® 410 to maintain upper pole height and fullness without excessive roundness.
By contrast, a moderately cohesive round silicone gel implant behaves differently because it does not have the same degree of shape retention or subsequent predictability. When upright, the upper portion of the round gel implant collapses and this may result in loss of upper pole fullness. Or, when a large volume round gel implant is used the upper pole may remain round and full. For some women this unpredictability may not be a significant problem, and others may prefer a round fullness to the upper pole; but for those patients who desire a natural sloping upper pole these results are unsatisfactory. With the Natrelle® 410 matrix, the surgeon has the ability to control breast shape in all 3 dimensions – height, width, and projection.
The 410 has a textured surface. This BIOCELL® surface texturing is the same textured surface that is present on Natrelle® tissue expanders. The surface texturing is designed to provide friction which holds the implant in place and helps to prevent malposition. If a smooth, round implant rotates within the breast pocket it does not affect the breast shape. But an anatomically shaped breast implant must remain in position to control breast shape. The BIOCELL® surface is an aggressive texturing that may also help reduce the risk of capsular contracture.
Because the 410 contains a highly cohesive silicone gel filling, the viscosity of the gel is much higher and the implant retains its shape, even when upright. This implant has been referred to as the ‘Gummi Bear’ implant because of these properties. The analogy is somewhat fitting, but the 410 is softer than most Gummi candies. And that is what makes the Natrelle® 410 special and unique – it is designed to provide a shape that holds, but remains soft to the touch. Since the highly cohesive gel filling of the 410 has much more structure (shape retention) compared to the more conformable, round ‘responsive’ gel implant, a longer tissue incision is required for 410 insertion. For this reason, most surgeons prefer to place the implant through an inframammary approach. The 410 requires a precisely-shaped pocket which closely approximates the dimensions of the implant; this also helps minimize the potential for implant rotation and malposition.
Because of the differences between round gel breast implants and the anatomically shaped Natrelle® 410, proper surgeon education and preparation are needed to obtain surgical outcomes. As a result, Allergan requires surgeons to complete a certification program, which includes instruction on surgical techniques and patient selection, before they are able to offer the Natrelle® 410 to their patients. Both Dr. Dembny and Dr. Sterkin have completed this certification program.
Stay tuned – More to come