Are "Gummy Bear" Implants Approved by the FDA?

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

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....

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.

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.

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

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

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

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. 

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

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