In 2013, Sientra became the first of three breast implant manufacturers to receive an approvable letter from the FDA, finally permitting the sale of the newest generation of shaped highly cohesive gel breast implants in the United States.
FDA approval for Mentor’s CPG and Allergan’s style 410 quickly followed. For American women this means new options are available for breast augmentation, breast reconstruction, and revision implant procedures.
But along with these new options arise a new set of questions:
- Which implant is safest?
- Which implant will last the longest?
- Which implant looks and feels the most natural?
- How will my plastic surgeon decide which implant is best for me?
What are the Differences Between the Newest Shaped Breast Implants?
First, women considering a breast augmentation with a silicone gel filled device need to understand that not only do these newer shaped breast implants differ from the round silicone gel implants that were approved by the FDA in 2006, but they differ from each other as well.
With respect to safety, each manufacturer was required to provide years of data on the safety and effectiveness of their implants to the FDA as part of the approval process. The FDA then reviewed all of the data before permitting device approval. Clinical trials for this generation of implants began in Europe in the early 1990’s. Studies in the US have been ongoing since 2000, and published data from each of the clinical trials demonstrates high levels of safety and patient satisfaction.
Highly cohesive gel implants have also demonstrated lower rupture and capsular contracture rates. This may partly be due to the fact that these implants are made with a thicker, more cohesive gel which helps prevent creases and folding of the implant shell over time.
Another difference between the implants is the percent of gel fill, or how much gel is placed within the shell. This contributes to the maintenance of the specific shaped of the breast implants over time, and may also contribute to their feel. The gel itself may also vary in cohesivity between manufacturers. Remember, silicone can be produced as a liquid or a solid, and breast implants fall somewhere in between.
There are other differences between the Sientra, Allergan, and Mentor implants such as their surface textures and the number of size options available in each style.
It is difficult to answer the question as to which implant will “feel” the most natural. There are multiple factors that contribute to the feel of an augmented breast. A “natural” twenty year old’s breast certainly feels quite different from a “natural” 50 year old’s breast.
In addition, the feel of an implant is the combination of gel cohesivity, percentage of gel fill, the specific shell of the implant, and of course, how much body tissue lies between the implant and the skin.
A potential benefit of a highly cohesive gel breast implant is that they were designed to be adequately filled, so they are less likely to fold on themselves, while producing consistent, long lasting outcomes. In certain patients, highly cohesive breast implants may feel firmer than the less cohesive round gels. In other patients they may actually feel more “natural” due to their ability to resist creases and folds.
Finally, there is probably no one best breast implant for every woman. Each device has benefits as well as trade-offs. Breast augmentation is more than just a surgical procedure, and requires thorough patient education and pre-operative planning. Most importantly, women should be aware of all the implant choices available to them as new devices finally come onto the US market.