Breast augmentation is one of the most successful and sought after of all body contouring procedures in plastic surgery. A huge part of any breast result is the implant. Prior to 1991, silicone gel breast implants were the most widely used. From 1991 to 2006, saline breast implants were the only option as the FDA removed silicone implants from the market. Since 2006, silicone gel implant have come back to add two implant options for women considering breast augmentation.
While having two breast implant options is a definite advantage, it also causes considerable patient confusion. Misconceptions and myths surround silicone implants largely because of its checkered FDA history from nearly twenty years ago. As a backdrop to the current silicone implant has been the development of a new generation silicone implant, known by his public name as the gummy bear breast implant.
Patients frequently ask about the gummy bear implant. Whether because of its cute name or the perception that it is better, women often want them specifically for their breast augmentation. In understanding the gummy bear implant, one has to appreciate the current silicone gel breast implants reintroduced in 2006. These are really fourth generation silicone implants that have a thicker, more cohesive silicone gel filler. (it is not a liquid nor is it a solid…but it is more cohesive or solidified than previous forms of silicone gel) They are not what is known as the gummy bear implant, a term by which this fifth generation silicone implant has been coined by some plastic surgeons. (not the manufacturers)
What is the gummy bear implant? It is an implant that is filled with a silicone gel material, which is not just thick and cohesive, it is what is known as “form stable.” This stability of the material occurs because it is more ‘cross-linked’ which creates a gel that is both solid and soft. Just like the gummy bear candy, the implants feel soft and pliant but bounces back from the touch. Equally importantly, when the implant is cut the material retains its shape. This means that compared to all previous generation silicone implants there is no chance of filler leakage. It can not leak or run because its form is stable.
Many people confuse the cohesive silicone breast implants released in November 2006 as the gummy bear implant. They are not. Gummy bear implants have been in long-term clinical trials in the United States for many years but have never been available outside of these clinical studies. Both existing U.S. breast implant manufacturers, Mentor and Allergan, have conducted clinical trials with their versions of the gummy bear implant. Mentor’s implant is known as the CPG, Allergan’s is known as the 410. The manufacturer’s do not use the term gummy bear nor do they sanction such a term. Those clinical trials have now been closed for some time as their clinical data has been submitted to the FDA for review. This means that gummer bear implants are not available for us in the U.S. currently. They have been been widely available in Europe and elsewhere for years.
The gummy bear implant, while being a cute nickname, specifically speaks to the nature of the filler material. It is soft and pliant but firm and strong. And just like those colored bear-shaped candies, you can push, pull and even cut the material and it won’t lose its shape. This fifth generation silicone breast implant may possibly be available for patient use in the U.S. later in 2011 but is not currently available.
Dr. Barry Eppley
Indianapolis, Indiana