FDA Approves “Gummy Bear Breast Implants”

MakenzieR on 13 Mar 2012 at 11:45am

gummy bear breast implant feel

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.

gummy bear breast implants

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?

Sientra Silimed breast implants

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. 

Are you excited about the gummy bear implant? Would you want something so new to the market? 

Lead photo: Anna Tesarewicz/Deposit

Comments (35)

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Are the round sientra implants still considered the type 5, or form stable gummy bear implant?
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yes they are! They are the implants that I named Gummy Bears in 2004
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Dr. Stevens: I have the High Profile Contour Mentor Saline textured, 680's after double mastectomy. I need new implants due to pectoral separation and bottoming out. are there any new Implants that have a similar projection?
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Yes, the shaped high profile Sientra have a great projection for you. g
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I was quoted by PS in Newport Beach round Sientra cohesive implants at $2000 AND $500 more if they are textured rounds. Does anyone know if this is correct?
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We charge 1500 for textured round Sientra implants.
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I had a breast lift and Sientra high profile implants put in 2 weeks ago. I was always a 36 c but after having children I was extremely saggy and deflated. All I wanted was my prepregnancy breasts. I'm still in the healing process but that is exactly what I got. They are beautiful and already soft and they look exactly how I looked prior to having children. I am very happy with these implants and its only been two weeks. The doctor saidni will be even more pleased when they settle but to me they looked as though they dropped into place the first day. If you're considering implants definitely consider Silimed/Sientra implants.
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But, can textured implants bring along other complications too???
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They are simply the best implants in the world. The research and studies have proved it
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I agree. I had my durgery dec 10 about few weeks after and they look and feel great. No excercises cause they are textured.
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Congratulations ! The Sientra textured implants have the very best results and the lowest complications. Enjoy them!
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got my gummies in costa rica sep 3, 2012. still in the healing process. so far love the look, feel, and happy.
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oh yeah, my implants Motiva round, high profile
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Thanks for your input. I certainly don't mean any offense in this term. We simply want to convey the difference in the cohesiveness. I have used Sientra ( Silimed) implants since 2003 and have put in over 900. I have never had a women ask me to remove them and replace them with other types of implants. Not all Gummy Bear Breast Implants are equal. The Sientra implants come in round and are much softer than some of the others that I have felt. All the best. Dr Grant Stevens
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I participated in a clinical trial using the Allergen 410s following a bilateral mastectomy. I ended up swapping them out for round silicone (Allergen high profile) last summer, prior to having my nipple reconstruction.

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)
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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. :/

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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. :)

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Thanks, Makenzie / Megan. I will definitely check it out. I'm thrilled with my results and hope the experience can be a resource to other women going through this.
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Our patients with Silimed- Sientra Gummy Bears are very happy and I have not "swapped" out a single one for type 4 gel.

All the best. g
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Thanks for your info. That is not the experience of my surgeon or his colleagues involved in the trial. Many patients have been unhappy (I personally know five women that swapped them out) and my surgeon is no longer a fan (nor are any of the other surgeons I consulted before making the decision). My surgeon will still use them if a patient requests them, but they are not recommending them upfront as they did three years ago. I suppose it's possible that the round textured are an improvement, but the cohesive silicone was heavy and didn't pass the 'hug' test. Just as an fyi, I saw the Nightline piece tonight and was unaware that you coined the term 'gummy bear'. The women in my support group found the moniker highly offensive in that it minimized a procedure that for us, was not 'elective'. This is a pervasive feeling in the breast cancer community. Just thought you might want to know. Best, BA
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You did my cousins gummies 5 years ago, they still look gorgeous even after her baby:)
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Thanks so much for the info:-)
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Absolutely. Good luck on your journey :)

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Thank you. Does anyone, by any chance, know what the price range for augmentation with these implants is???
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