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Perez Plastic Surgery

Sientra: The New FDA-Approved Shaped Gel Breast Implant

Breast augmentation surgery is the most commonly performed surgical procedure in plastic surgery. Following the breast implant lawsuit crisis of the early 1990’s most silicone gel manufacturers fled the U.S. market. Only two companies, Allergan (formerly McGhan/Inamed) and Mentor/J&J, remained and have dominated the market for the past 20 years. One consequence of this implant duopoly is that the cost of breast implants increased from hundreds to thousands of dollars since the 1980’s.


Earlier this year the U.S. F.D.A. which regulates medical devices approved a third breast implant manufacturer. Santa Barbara based Sientra was approved to offer silicone gel prostheses for sale in the U.S.  Allergan and Mentor are also based in Santa Barbara, leading to the affectionate term of “Silicone Alley” for the Southern California region.


Dozens of breast implant companies exist throughout the world. Many of these brands are sold in Latin America. Sientra’s parent manufacturer has sold implants internationally, but of course U.S. approval is a highly coveted achievement.


A Good Thing…and a New Thing


The arrival of a third player to the U.S. breast implant market is expected to be a good thing for American women. In addition to providing greater competition, Sientra offers a unique line of shaped gel implants. These “teardrop” or “anatomical” breast prostheses are commonly used in Europe and Latin America. A saline-water filled version has been available for years in the U.S. However, Sientra is the only manufacturer granted F.D.A approval for the gel filled type.

Shaped implants offer greater options for both cosmetic and reconstructive breast surgery. The prostheses come in a variety of shapes, sizes, base diameters and projections giving both the patient and surgeon greater versatility in body contouring.


The augmentation procedure using shaped implants is different from the traditional round prosthesis insertion. Therefore it is advisable that patients choosing these implants consult with experienced breast plastic surgeons. As a corporate philosophy, Sientra will only sell and warranty implants placed by plastic surgeons recognized by the American Board of Plastic Surgery.


Editor’s Note: Dr. Perez can be seen on ABC News in Miami discussing the Sientra implant at:



About the Author:


Dr. Perez is a member of the NOVO National Council of Leaders in Breast Aesthetics. He has served as a consultant for both Mentor (J&J) and Inamed (Allergan). Dr. Perez has lectured internationally on the subject of breast surgery and has been selected among the Castle Connolly (U.S. News & World Report) America’s Top Doctors. More information is available at

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