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Further, what is the difference between the silicone gel and the "gummy bear," if any?

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FDA gummy bear implants

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12 Doctor Answers | Asked by Cate in Chicago

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Editor's Note: The FDA approved Allergan's Natrelle 410 implant in February 2013.

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... more

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... more

"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....

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... more

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... more

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.

Steven Wallach, MD

12 reviews

Manhattan Plastic Surgeon

Gummy bear breast implants not approved by FDA.

Hi. 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. ... more

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... more

Cohesive gel implants

Gummy bear implant seems to be the term given to the latest generation of gel filled implants. Mentor calls this memory gel. This is a cohesive gel implant that acts llke a solid but feels like a gel. It has been available without restriction since November 2006.

Many names for modern silicone implants

Hi there, Modern silicone implants have acquired various nicknames in the lay press, such as "gummy bear implants", in addition to the brand names the manufacturer's use ("Memory Gel" and "Natrelle"). They are all referring to the same material, called cohesive silicone gel. This material is much different than the silicone used in older generation implants, because it is much thicker, and more highly polymerized, so that (theoretically) if the implants... more

"Gummy Bear" not FDA approved yet, but expected to be soon

The Form Stable Silicone Breast Implant, AKA the "gummy bear" implant is expected to be FDA approved and available within the next year. This implant has been used with great success in Europe and South America for the past decade. The FDA has performed extensive testing, including ongoing clinical trials with leading plastic surgeons across the country. The difference between the currently available silicone gel implants and the "form stable" implants is that, the... more