FDA Approves “Gummy Bear Breast Implants”
Makenzie on 13 Mar 2012 at 11:45am
After much anticipation, the FDA has finally approved the original “Gummy Bear Breast Implant.” Silimed brand implants are now the only FDA approved, form-stable, highly cohesive gel implant. This makes Silimed (and their distributor, Sientra) the first company to compete with Allergan and Mentor since silicone was re-approved for use in 2006.
What does that mean to the consumer?
There was such a large interest while gummy bear implants were still in clinical trials that some women even flew cross-country to be among the first to get them.
Dr. Grant Stevens participated in the trials. He put in his first pair in 2003, and coined the term “gummy bear” because of their consistency.
“‘Gummy bear’ is more than a cute nickname; it's a clue about the nature of the filling,” reads his website. “It's at once soft and firm, pliant and cohesive, strong and beautiful. And just like those cute little red, green and yellow bears, you can push, pull and even cut the material and it won't lose its shape.”
That’s the key difference between Silimed’s implant and those currently on the market -- it’s form-stable and won’t lose its shape. Dr. Stevens notes that this is a huge breakthrough for women who need implant revisions, because having a form-stable implant is important once the breast pocket is already stretched out.
He describes the newest implant as being a “type 5 gel,” because it’s the 5th type of silicone gel implant on the market since 1962. However since he started using the term “gummy bear” implant, there’s been a lot of confusion about what it actually means.
“Some people started calling type 4 gel ‘gummy bear breast implants,’” he told RealSelf. “Those are cohesive, but they’re not form-stable. So many people used the term gummy bear to market type 4 gel.”
Think of it this way:
Sientra/Silimed brand = form-stable, cohesive “gummy bear implant.”
Mentor or Allergan/Natrelle = cohesive gel but not form-stable.
Why are women so anxious for this implant?
Before they were FDA approved, plastic surgeon Dr. York Jay Yates broke down the pros and cons:
Purported Advantages over current silicone gel implants:
- Improved breast shape
- Decreased capsular contracture rate
- Decrease risk of implant rupture
- Decreased risk of rippling of the breast
Potential Disadvantages:
- Increased cost
- Feel - they are firmer than memory gel implants.
- Longer scar
- Possibility of rotation - The implants are "anatomic" or "tear-drop" shaped and there is a possibility that the implant could rotate early in the healing process leading to an unusual shape [though a textured surface can help prevent this]
- Difficulty with secondary surgeries such as removal and replacement of implants due to the textured surface of the implant causing in-growth of tissue onto the implant capsule
The lower risk of capsular contracture was indeed shown in Dr. Stevens’ (& Co) study of 355 patients over a 60-month period, as was the decreased wrinkling and rippling.
After speaking with Sientra CEO Hani Zeini, Dr. Stevens told RealSelf that they "haven’t set the price yet but it will be comparable [to current silicone]" will be available in as little as two weeks time.
I know many women who participated in the trial and are dissatisfied. My own surgeon has a high percentage of patients who have replaced them with other implants and is no longer recommending the option to new patients.
I did not like the firmness (people noticed how hard they were when they hugged me), they were heavy, and lacked projection -- so much so that they were very difficult to fit with a bra.
We also discovered one of the implants had rotated when it was removed.
I couldn't be happier with the round silicone and have not experienced any rippling (which is always a concern).
In summary, while cohesive silicone may be the right option for some, I think it is highly dependent on frame and body type. The same way that skinny jeans and bell bottoms don't work on all body types, I'd caution women against lining up to get them just because they are the newest thing. Expectations need to be discussed with your plastic surgeon and they will know what implant will work best for you.
One other footnote -- I never knew that someone actually coined the name 'gummy bear' -- we all thought it was just based on the materials --- but there are many women in the BC community that positively cringe when they are referred to as that because it infantilizes a very serious disease by reducing it to a popular candy. (Just some feedback I got in my support group)
Wow, thank you so much for such a thorough review! I'm glad you're happy with your round silicone now. I have the same kind and can't imagine anything firmer in there. :/
This is some great information you have shared BlondeAmbition! I must say I particularly like your parallel to skinny/bell bottom jeans, good visual we all can relate to.
Not sure if you are already know this, but we have an entire community dedicated to Breast Reconstruction, and the women in there are absolutely fantastic! Would love to have you check it out & share your story if you feel comfortable doing so. :)
All the best. g
Absolutely. Good luck on your journey :)
They're saying it will be comparable to current silicone prices. The average reported price on RealSelf is $6,600, but that's for all kinds. Typically silicone are around $1000 more than saline in any given demographic.
According to our sources, what makes Sientra unique from the other companies in trials with type 5 silicone gel implants is that they do make them in round as well as anatomical, and both were approved last week. You can see their offerings on their website. (Though it's worth noting they did not apply for approval for their saline implants, which are also shown on the site).
From what I've learned, Sientra not only has anatomically shaped implants but also round implants, so you don't have to worry about the shape-0shifting.
Anatomical implants are frequently textured as well, to help them stay in proper position.