Although the gummy bear breast implant has been used in Europe for over 15 years, this type of silicone gel implant is relatively new to the United States. Many breast augmentation candidates have never heard of the gummy bear breast implant before, and there’s no better time to learn about them than now.
What is the “Gummy Bear” Breast Implant?
Officially called Style 410 cohesive gel breast implants, gummy bear implants are a specific type of silicone gel implant that is solid yet pliable, even on the inside. Plastic surgeons have coined the term “gummy bear” as a way to explain the consistency of cohesive gel implants to their patients. When the implants are cut open, they appear to have the consistency of a gummy bear.
The solid, yet pliable, gel doesn’t leak at all if an implant ruptures, one of the main benefits of the gummy bear implant over saline and traditional silicone gel. The implants are also referred to by the brand name “Sientra,” which is currently the only type of cohesive gel implant approved by the FDA to date.
Another benefit of cohesive gel implants is that they reportedly look and feel more natural than traditional options. Many U.S. women who’ve already undergone a breast implant surgery are going back for a second surgery to replace their original implants with gummy bear implants.
FDA Approval of the Gummy Bear Implant
In March 2012 the FDA approved the Style 410 Breast Implant—also called cohesive gel and gummy bear implants—for use in the United States. The implants were approved after an 8-year clinical trial involving over 18,000 women over the course of more than six years.
Before March of 2012, women were not able to receive gummy bear implants in the U.S., even though they have been the preferred type of breast implant in Europe and parts of Asia for over 15 years. Any woman who received gummy bear breast implants before March 2012 was part of the clinical trial. FDA approval of the implants is still contingent on longer-term studies of Sientra. The cohesive gel breast implant manufacturers Allergan, Mentor, and Silimed are all currently undergoing clinical trials of their products for approval by the FDA as well.
The FDA placed a moratorium on silicone breast implants in the U.S. for over 20 years, which was lifted in 2006. Since that time, the popularity of silicone implants has risen dramatically. The American Society for Aesthetic Plastic Surgery reports that breast augmentation continued to be the most popular type of plastic surgery among women in 2011, with 69% of the surgeries using silicone implants over saline. With cohesive gel implants now approved in 2012, we can expect these statistics to increase even more.
How Gummy Bear Implants Compare to Silicone Gel and Saline Implants
Cohesive gel breast implants are a type of silicone gel implant with the consistency of a gummy bear, which means that there is no risk of leakage if one ruptures. A chief criticism of traditional silicone gel implants, and the reason that they were banned by the FDA for so long, is the risk of leakage in the event of a rupture.
The silicone gel inside an implant is a liquid that can leak into the body if the implant has a hole, rupture, or other puncture damage. Because the leak is usually slow, it isn’t immediately noticeable and a fair amount of the gel may leak into the body before a woman realizes she has a rupture. The full effects of the leakage are unknown, but include an increased risk of breast cancer. In the event of a rupture, the implant must be removed and replaced as soon as possible. It’s important to know that recent developments have made rupture of silicone implants much less likely.
Even though saline implants are more prone to rupture than silicone gel implants, these implants have been a popular choice as a safe alternative to silicone among women undergoing breast augmentation. More women choose silicone gel over saline overall, however, because the implants look and feel more like the real thing. Saline implants can also be overfilled, causing the breasts to become hard. However, the overall risk of rupture in either type of traditional implant is low.
Gummy bear implants look and feel more natural than both traditional silicone gel and saline implants. They also have less chance of rupture and rippling because of their solid yet pliable consistency. You can expect to see a drastic increase in the number of women receiving these types of breast implants over the next several years as they gain recognition and increase in popularity.
Beverly Hills Physicians board certified doctors are some of the first in the United States to offer this exciting new option. Schedule a free consultation and decide which implant option is best for you.