“Gummy Bear” Silicone Breast Implants Just Approved by the FDA for Usage
After waiting years for approval of the widespread usage in the United States of the so called “gummy bear” silicone breast implants, the U.S. Food and Drug Administration (FDA) yesterday finally announced their formal approval to the manufacturer of this implant, Allergan, Inc. This implant will be officially known by the marketing name Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants or Natrelle® 410 for short.
Or “gummy bear” implant if all this is too technical!
This breast implant has undergone the most rigorous scientific research for years and that has also included numerous clinical studies. Additionally, it has already been used worldwide for 20 years including in Canada and Europe. What has been learned is that women love them overwhelmingly (and so do men!). In fact, the satisfaction rate in those who have them is 96.5%, which even exceeds the already extremely high rate of satisfaction associated with the silicone breast implants that we have been using.
There are a few characteristics that make this silicone breast implant unique – and its formal name says it all. It is an anatomically shaped implant in the form of a tear drop or wedge compared to the round implants which have been used for decades. It also consist of a silicone gel that is highly cohesive – it sticks together to a very high degree, far greater than any other previous breast implant. Consequently, it maintains its intended anatomic tear drop shape for a more natural look but still has somewhat of a soft feel. Additionally and importantly, there has not been noted to be any silicone gel migration from the implant at 7 years.
This gummy bear implant also has the advantage of staying in place versus what can happen at times with the round breast implants. This is a double-edged sword in some ways, though. A well trained experienced plastic surgeon can place it precisely where it is desired allowing for even greater control of shape and other factors. There isn’t the so called “dropping” effect that many people have heard about with the round implants (though this doesn’t really occur either). Conversely, if the insertion is not performed skillfully, the results may reflect this.
Because of how this implant is constituted, the associated risks of rippling or wrinkling are virtually non-existent – at less than 1% at 7 years in primary breast augmentations. This is less than that of the “present” day round silicone breast implants and light years better than that associated with the saline breast implants.
This style 410 silicone breast implant is intended for usage in breast augmentation, breast reconstruction and breast revision surgery with the additional FDA stipulation that a woman must be at least 22 years of age. It will also not be for everyone who wants silicone breast implants. In fact, it may end up be a niche type choice partially because the results will be more “natural” in appearance which is not what many women are looking for (though many are as well!). The round implants that we are presently using provide that more popular appearance of considerable fullness – that round, push-up bra look.
And then there is the cost… It will be priced higher than the round silicone breast implants.
Once these Natrelle® 410 implants become physically available within the next week or so, I will be offering them as another silicone breast implant option.
For more information on the newly introduced Natrelle® 410 silicone breast implants, on breast augmentation surgery in general or on any other plastic surgery procedure that I perform, please call my office at 480-451-3000.
Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona