FDA Approves “Gummy Bear Breast Implants”
MakenzieR 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?
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
- 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.