Are "Gummy Bear" Implants Approved by the FDA?
Doctor Answers (12)
Gummy Bear implants not yet approved
First thing to do is clarify what the various terms mean. The term "gummy bear" was originally used to describe the fact that the silicone gel in these implants is more like a semi-solid so it doessn't leak out. The word for this is "cohesive." What has confused a lot of people though, is the fact that all gel in every type of silicone implant now is cohesive. In other words, you could slice them in half and the gel doesn't go anywhere.
Rather than "gummy bear," the preferred term for these firmer implants is "form-stable" because they are made into specific shapes as opposed to round like silicone implants on the market now. This brings up another confusing term, which is "anatomic," used to describe the shape of these implants, but is highly debatable.
Approval of the form-stable implants (Allergan style 410, Mentor CPG) has been anticipated for some time, as the clinical trials have been completed and application made to the FDA. When they are available, they will provide an option, but you will still need to consider pro's and con's. For example, because they are firmer they may not feel as natural and a longer incision (hence a longer scar) may be necessary to put them in. Round implants tend to move and behave a lot like natural breasts.
The bottom line is, all silicone implants have cohesive gel, and it will become even more important to review all options when making a decision about breast augmentation.
Gummy bear implants are not yet FDA approved
There is a lot of confusion about "gummy bear" implants. These are the yet to be FDA approved form stable cohesive gel implants that are used in Europe, and South America.
The purported advantages of form stable implants over current silicone gel implants include: (it is important to note that these are largely theoretical as there is no long term data as the implants are relatively new)
Improved breast shape - the breast implant can hold its shape and effect the overlying tissue
Decreased capsular contracture rate - capsular contracture is in part due to silicone "bleed" from the breast implant. There is theoretically less "bleed" in a cohesive gel implant.
Decrease risk of implant rupture - Breast implant rupture is often caused by a "fold flaw" in the implant. This is an area of repeated folding on the breast implant that eventually causes it to wear out. The gummy bear implants may have decreased folding due to their form stable nature.
Decreased risk of rippling of the breast
Form stable cohesive gel implants have their disadvantages as well:
Feel - they are firmer than memory gel implants.
Longer scar - the implants are not able to be squeezed through the same size of incision as other silicone implants
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.
Difficulty with secondary surgeries such as removal and replacement of implants due to the textured surface of the implant causing ingrowth of tissue onto the implant capsule
"Gummy Bear" breast implants
The term "Gummy Bear " has been applied to both the, currently used, cohesive gel implants and the, yet to be FDA approved, form stable implants. This has created considerable confusion both among the lay press and the medical community.
Form stable implants are more cohesive (thicker) than the currently available cohesive gel implants. This provides shape to the implants and thus more predictable shape to the breast, and is an advantage in breast reconstruction.
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Yes, "Gummy Bear" Implants are now available in the USA
Form shaped anatomic implants are now available in the usa. I have used these implants for over a decade while in practice for a time outside of the usa. They are now, I hear, the most popular implant in the world outside of the usa. It took time for their benefits to be appreciated by the plastic surgery community.
Some people are attracted to them because a hole in the shell does not lead to a "flow" of silicone out of the implant.
To me there are many other important cosmetic reasons for selecting an oval form shaped implant in many cosmetic cases.
Gummy Bears ARE Available now!
Sientra Breast Implants have recently been approved for use in the US. I have used over 900 as part of the FDA study which I began in 2oo3. They are not hard as some have suggested. They come in round and anatomic shapes and they can be placed through the nipple if you wish. They do not leak when a hole is cut in the shell and they are suspended. These Sientra Breast Implants are the most cohesive gel available to date and the only form stable breast implants to be approved for use in the US.
Gummy breast implants
Gummy implants or cohesive gel implants to this date are not approved for general use in the US by the FDA. They are still under research protocol only.
Gummy bear breast implants not approved by FDA.
The "regular" silicone breast implants are made of highly cohesive (sticky) gel The gummy bear breast implants are even more cohesive and rigid and do not lose their shape. But they are also quite hard. It is not clear who they will be good for.
'Gummy Bear' implants not yet FDA approved in the US
This is a confusing topic for many. Gummy bear is a marketing term that has developed along the way. It refers to a 'form-stable' cohesive gel breast implant that is available in some places outside of the United States (in Canada and Europe).
Currently, in the United States, the FDA has approved a 'cohesive gel' silicone implant; however, this implant is not as 'cohesive' as the 'Gummy Bear, form-stable' implant. This implant will likely be available in the U.S. in the upcoming future. At the moment, there are a few sites in the U.S. that are offering these implants as part of a research study.
Gummy bear vs Cohesive gel
The real Gummy Bear implants are not FDA aaproved yet for general use. Only few clinical trials around the country were available. There is a lot of interest in the form stable implants that been used in Europe and elsewhere for years.
Few patients come and ask about these implants. I beleive there is a little confusion by the public when it comes to the gel, silicone, "gummy bear," and cohesive implants. It is very simple and we need to make it clear. Gel, silicone, and cohesive are the current FDA approved implants. Gummy bear is a term invented to describe certain properties, and I refer to it as the newer implants that will be approved in the near future.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.