Gummy bear implants are available as part of FDA studies for primary augmentation and reconstruction
The highly cohesive form stable silicone devices, Allergan Style 410 and Mentor CPG, are available as part of ongoing FDA studies. They are not yet approved for unrestricted use and there are a limited number of surgeons in the United States who are participating in those studies. The Allergan devices are approved in Canada, Europe and Australia. There are two separate trials for the Allergan 410(gummy bear) device, one for patients that have never had implants and another for those undergoing breast reconstruction or who desire removal and replacement of their current implants.
When one looks objectively at the data and the "trade offs" of all the devices- saline, traditional silicone, and highly cohesive form stable gel there are some potential advantages for some patients with the form stable devices. Particularly for breast reconstruction, as well as for those breast augmentation patients with thin soft tissue cover who desire a very natural result . I have not had a patient complain of firmness with the Allergan 410 device. Having said that there are upsides and downsides to the decision making. If you are interested in a gummy bear device seek out a plastic surgeon who will review the options and trade-offs after taking your history and listening to your desires and expectations. An examination and careful measurements of your breast and chest dimensions and tissues are important in the decision making process.
You may also want to ask your surgeon to arrange for you to speak with patients who have the device you are interested in to get the patients perception of how they feel.
Regular Silicone Gel Vs Gummy Bear Breast Implants?
Thank you for the question. All currently FDA approved silicone gel breast implants are “cohesive”. The “gummy bear” silicone material is a more dense material chemically. The term “gummy bear” has been used, almost as a slang term, to encompass all silicone gel breast implants; thus the confusion.
Cohesive gel implants are not available for mass market use in the US. They are only on research protocol. In general, they are firmer and require larger incisions.
There are multiple implant styles, shape and sizes currently available and other that may be introduced in the US over the next few years. It is not possible at this point to absolutely tell a patient that the viscosity of one gel implant is better than another. The Style 410 Allergan implant, which is currently available in Canada, does feel a bit firmer than the currently available gel implants but in certain patients it may be better. It is just too early to tell.
I wish they all could be...
We just don't have enough information available yet on the "gummy bear" or form stable implants to know who IS a candidate for them, much less who should not get them. The one fact that would make you NOT a good candidate for a "gummy bear" is the fact that they are not yet available. Good luck!
Gummy bear breast implants.
The gummy bear breast implants are still experimental and not approved by the FDA. They can feel quite hard, and it is not clear in my mind who they will be good for.
In NYC, we are currently getting excellent results with Mentor MemoryGel cohesive gel implants. So I am taking a wait and see attitude.
I like the regular silicone.
I personally think that the gummy bear are too hard. I like the feel of the regular silicone. Also the Allergan are only approved for breast reconstruction after cancer.
Your doctor may be more comfortable using old silicone implants
Once you have decided that the long term risks of silicone gel are OK, why not get the cohesive gel implants to try to minimize that? Maybe your doctor is more comfortable with the older implants.