FDA Approved Silicone – Gel Sientra Breast Implants

Silicone-gel breast implants recently achieved a milestone:  The 50th anniversary of the first silicone implants used for breast augmentation. In March 2012, silicone implants reached another major breakthrough in the plastic surgery realm. The U.S. Food and Drug Administration (FDA) approved the use of a new brand of high-strength cohesive silicone-gel breast implants. Sientra, a California based manufacture, is one of only three FDA approved breast implant manufacturers. Allergan and Mentor are the other two companies that currently produce FDA approved silicone-gel implants.

Silicone breast implants consist of silicone gel encased in an outer shell made of silicone. Saline breast implants are encased in a similar silicone elastomer shell, but they are filled with a sterile saline solution instead of silicone gel. Both types of breast implants can be placed above or under the chest muscle.

Saline breast implants are available in different shapes, including teardrop and round. Until Sientra’s recent FDA approval, silicone breast implants were only available in a round shape. The Sientra implants differ from their silicone implant competitors as they offer both shaped and round cohesive silicone implants that are known for their single shape retention. Some patients prefer shaped implants because they can offer a more natural look on certain body types.

Although similar breast implants have been available outside of the U.S. for numerous years, the Sientra implants were FDA approved after three years of clinical trials involving 1,788 participants, and they will continue rigorous studies for the next seven years. Sientra offers more options than previous silicone implants have with a selection of sizes, profiles, projections and implant textures.

Although, these new implants are highly regarded, implant selection should ultimately depend on each individual’s concerns and desired look.  As I tell all my patients, it’s important to do your research if you are considering a breast augmentation and discuss with a board-certified plastic surgeon all the options available for you.

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