In my blog, Gummy Bear” Silicone Breast Implants Just Approved by the FDA for Usage, I shared with you the news that the FDA finally allowed widespread usage of these next generation silicone breast implants after over a 12 year wait. Also, rather than being referred to as “gummy bear” implants, they have now been given an official name, the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants – or Natrelle® 410, for short.

Is this an earth shattering event?

Has there been a recent increase in seismic activity or an unusual number of earthquakes subsequent to this announcement?

No, and of course not!

However, if you are considering having a breast augmentation or a mastopexy (breast lift) with implants, now you have one more option available to you. These Natrelle® 410 implants do have several advantages over the round highly cohesive silicone gel breast implant (as I noted in that post). There are also a few drawbacks.

These are anatomic shaped implants (tear drop in configuration) so if you are looking for a “push-up” look with a lot of roundness and fullness at the top of your breast, this style implant will not be for you. If you are also desiring to be disproportionately large, the same holds true – so go with the round silicone breast implants.

These Natrelle® 410 implants require far more precision in their selection and insertion than the round silicone implants (although I already am very precise and meticulous as regards the round silicone gel implants). In fact, this is such a crucial issue that that any plastic surgeon desiring to offer these implants must obtain certification for their usage.

And guess what?

I have completed the certification program and am fully certified to offer and use these Natrelle® 410 implants.

Finally, these new implants are substantially more expensive than the round silicone gel breast implants. Consequently, this will translate into a significant premium to the cost of undergoing a breast augmentation if you opt for using them. This additional expense to the procedure will vary among plastic surgeons, but it could be in the range of $2000 – $3000 more.

If you would like additional information on the new Natrelle® 410 silicone breast implants or on breast augmentation surgery in general or if you would like to schedule your complimentary consultation with me, please call my office at 480-451-3000.

Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona

Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

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

The term “gummy bear” breast implants has been used in the public realm for several years now yet most people know little about them. What they have heard is that they are the latest type of silicone breast implant and something that they may just want to have for their breast augmentation or breast reconstruction.

You might have wondered: “Exactly what are these breast implants and why are they named after a candy?”

You may even be thinking: “Can I have them for my surgery?”

“Gummy bear” implants are a new generation of silicone breast implants that have some of the characteristics of the candy that they were nicknamed after – though they are not also edible! These implants differ from all earlier versions in that they are composed of a very highly cohesive and form-stable (maintains their shape) gel that resembles the candy though softer.

These 5th generation breast implants have been used elsewhere around the world for breast augmentations and reconstructions since the early 1990’s. They have been extensively researched for years including in large clinical trials but have not yet been cleared by the FDA (Federal Drug Administration) for usage here in the United States although approval may be imminent. (Note: Plastic surgeons here in the United States have been hearing this for several years now – and we are still waiting!)

These new silicone breast implants do offer at least a few advantages over the current cohesive silicone gel ones (as well as some disadvantages). They have been noted to be more durable and last longer and the potential of the silicone gel migrating elsewhere is close to zero. The risk of developing hardness around the implants known as capsular contracture has been found to be lower, around an incidence of 3% as compared to 5 – 10% or more with previous generations of silicone implants.

A definite disadvantage of these “gummy bear” implants is the cost which is expected to be significantly more expensive than those that are used now. Whether this difference is an additional several hundred dollars or much more is not known as of yet. Their increased cost will definitely have some effect on their popularity and selection. Ultimately, however, several factors will play a role in influencing each woman’s decision regarding which type of silicone breast implant is right for her.

For more information on silicone gel breast implants, breast augmentation surgery or for any other plastic surgery procedure that I perform or to schedule a consultation with me, please call my office at 480-451-3000.

Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona