New Shaped Breast Implants Approved

With the recent USFDA approval of Allergan’s Style 410, form-stable, highly-cohesive, anatomicallyshaped breast implant, a new chapter in the 50-year history of the silicone gel breast implant is about to begin. The Allergan 410 has been involved in USFDA-approved clinical studies for almost 12 years. Published scientific articles on clinical outcomes with the Allergan 410 and the competing Mentor CPG show improved clinical outcomes as compared to the conventional round, smooth-shell breast implant that is used by most American plastic surgeons.

Currently, there are two USFDA-approved anatomicallyshaped breast implants in the US marketplace. In 2012, Sientra achieved approval of its shaped implants which have the same gel configuration of its round implants. The Allergan 410 was approved on February 20, 2013. The status of the Mentor CPG’s USFDA approval is unknown at this time.

Anatomically-shaped breast implants offer patients a new dimension in breast augmentation, with an outcome that appears to resemble a normal breast shape versus the round upper breast look. The shaped devices appear to function as an internal breast form that shapes the breast versus filling the envelope. For the most part, 95% of patients undergoing breast augmentation with the Allergan 410 report satisfaction with their outcomes. Risk of capsular contracture with the shaped breast implants are reported to be lower than published incidence with the round, smooth implants. To date, the experience with shaped implants in the United States has been restricted to a handful of approved investigators.

American plastic surgeons will need to develop an understanding of device texture, utilize more sophisticated tissuebased planning, and employ precise surgical technique compared to their current knowledge of round, smooth devices. The other important factor is improving our management of patient expectations that drive reoperation rates for size change. There is much to be learned from the experience of individuals who have been using these devices outside of the US for many years. Proficiency with anatomically shaped devices takes some time and requires attention to detail in all parts of the process so as to produce great long-term outcomes, lower rate of adverse events, and higher patient satisfaction. Shaped breast implants are not for every patient, yet for individuals whose tissue characteristics permit their use, excellent long-term outcomes have been reported.

Mark Jewell, MD – United States
ISAPS National Secretary for the United States
The author is an approved clinical investigator for Mentor and Allergan and a consultant to Allergan.

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