Gummy Bear Implants…They are Finally here, and We’ve Got Them!!!
Last Spring the FDA cleared the first and only form stable or “GUMMY BEAR” silicone breast implants for use in the U.S. Sientra is the American affiliate of Silimed, a worldwide distributor of breast implants for over 30 years and the company that manufactures the new implants. I am very lucky to be one of the first New York City Plastic Surgeons with access to these form stable breast implants.
The new “Form Stable” implants from Sientra can actually be cut in half and squeezed, but still recover their shape, so oozing or leaking is very unlikely
While they look and feel very much like either of the other two silicone implant products available, the difference is in the structure of the silicone used in their production. These implants have an extremely low rate of rupture (Clinical trials demonstrate a rupture rate of just 1.8% in 10 years!). Furthermore, since they are considered to be “form stable” they don’t seem to leak or ooze silicone even if they did break. That is a dramatic improvement over other manufacturer statistics. This is a tremendous advance for American women who have been waiting for this technology for years. I anticipate their use becoming ubiquitous in a very short period of time.
In 2006 the FDA decided to allow the use of silicone implants in the US because there was absolutely no evidence that they posed any risk of causing autoimmune disease (as had been purported in the 1990’s). Since that time, breast augmentation has regained its status as the most popular cosmetic procedure in the country (outpacing liposuction). Many of my patients already know that I think silicone implants are far superior from an aesthetic point of view than the “water balloons” that we were forced to use all those years. However, although we think the cohesive silicone implants that have been available since 2006 are very safe, why wouldn’t a patient want a device that almost can’t rupture or leak?
Hopefully, the other two manufacturers (Allergan and Mentor) will be following up with their own version of these gummy bear implants soon, but that is to a large extent dependent on the FDA giving them clearance when they finish their own clinical trials. For now, I’ll be using Sientra form stable implants…
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