In March of 2012, Sientra received an approvable letter from the FDA, launching a third manufacturer in the US and ending the duopoly that has existed in the breast implant market for over 20 years. What this means for American women is that a new option, the shaped silicone gel implant, may someday become as popular in the US as it has become around the world. But with new options, there may be confusion. Women should know that not only are there significant differences between these newer devices and the round “responsive” gels approved by the FDA in 2006, but that each of the newer shaped implants, manufactured by Sientra, Mentor, and Allergan, all differ from each other. Each of the manufacturers of the newer breast implants were required to go through years of rigorous clinical trials in the United States; Mentor’s CPG, and Allergan’s Natrelle Style 410 are still awaiting FDA approval.
As a breast augmentation surgeon, I think that it is important to clear up the confusion regarding these new breast implants that have recently hit the US market, and the anticipated release of additional implants in the near future. For over twenty years I have been a strong advocate for women’s breast health, and a clinical investigator for five silicone breast implant trials, and women should not be fooled by marketing hype and plastic surgery advertising. There is a great deal of conflicting information circulating in the media and online concerning some of the newest silicone gel implants. This is an important topic because women need to be educated when it comes to their bodies and making life-long decisions that could later affect their health.
Differences between implants:
So what are the differences between the newer breast implants? There are several differentiating factors, and each plays an important role in the newer shaped breast implants. First there are differences in shell textures, second they each differ in percentage of gel fill, and third, the cohesivity of the silicone used to fill the implant may vary. It is also important to understand that silicone based polymers can range from thin liquids like Dimethicone which is found in almost all hair gels, to the solid silicone cutting boards used in your kitchen. Each of the new highly cohesive gel implants are designed to be just soft enough to feel like a breast, yet firm enough to reduce the wrinkles and ripples seen with less cohesive breast implants. What is essential to understand is that the “feel” of the augmented breast is the result of the combination of implant shell and fill, pocket location, and soft tissue coverage that together produce the overall “feel” of an implant. In addition most of the newer shaped breast implants are adequately filled, so they are less likely to collapse on themselves, which helps to achieve more predictable, long lasting results.
So which breast implant is right for you?
There will always be advantages and disadvantages to every breast implant, and no one breast implant is best for every patient. In addition, women researching their options in breast augmentation should recognize that the term “Gummy Bear” is a nick name, and only a nick name. As such, it may be used by plastic surgeons to describe a wide variety of silicone gel implants. Not all surgeons are referring to shaped, highly cohesive gel breast implants. Many of the surgeons that are using this term in their ads or blogs, either do not understand the science behind the various generations of breast implants, or regrettably, deliberately aim to confuse.
Choose your surgeon carefully:
If you are considering a breast augmentation with a shaped device, please do your homework. There are differences between each of the shaped breast implants. Each implant will have benefits as well as trade-offs. Breast augmentation and reconstruction with these newer breast implants require careful implant selection and precise surgical technique to avoid complications. Women considering a breast augmentation with one of these newer implants should seek out a plastic surgeon with the extensive experience and training using shaped breast implants.