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Silicone Gel Breast Implants: Science and Testing

Kinney, Brian M. MD; Jeffers, Lynn L. C. MD; Ratliff, Gregory E. MD; Carlisle, Dan A. BA

Plastic and Reconstructive Surgery: July 2014 - Volume 134 - Issue 1S - p 47S–56S
doi: 10.1097/PRS.0000000000000349
Cosmetic: Original Articles

Background: Since the first generation of breast implants, major design innovations, including consistency of the gel, palpability and thickness of the shell, and barrier materials in the shell, have been introduced. Surgeons have not had metrics to assess and compare available implants.

Methods: Research at independent laboratories included 4 tests: gel elasticity (the gel’s ability to retain its shape), gel compression fracture (the resistance to permanent gel deformation), gel-shell peel (the integration of the gel with shell as a cohesive unit), and morphological analysis.

Results: Sientra’s round High-Strength Cohesive (HSC) experienced the least gel elasticity (5.805 mm), whereas Allergan’s round implants experienced the most (7.465 mm). Among shaped implants, Allergan 410 experienced the least gel elasticity (3.242 mm), whereas the Sientra HSC+ implant experienced the most (4.270 mm). Sientra’s round (36.32 lbf) and shaped (44.16 lbf) implants demonstrated the highest resistance to gel fracture, with Allergan’s implants demonstrating the least among round (23.06 lbf) implants and Mentor Contour Profile Gel (CPG) among shaped (30.45 lbf) implants. For the gel-shell peel test, Sientra’s implant required over 26% greater force than Allergan’s implant and over 35% greater force than Mentor’s implant. Sientra’s shaped implants required more than double the peel force than Allergan 410 (119% greater) and Mentor CPG (130% greater). Morphological results showed Sientra’s implants preserved structural integrity (−1.10% change).

Conclusions: The initial findings show that these implant characteristics are individual factors to be considered separately and are not necessarily correlative. Further study of implants using these and other testing techniques will help clinicians choose between implants.

Beverly Hills, Oxnard, and Santa Barbara, Calif.; and Tulsa, Okla.

From the Department of Plastic Surgery, USC School of Medicine; Department of Plastic Surgery, OU College of Medicine; OSU College of Osteopathic Medicine; Integrated Breast Center at St. John’s; and Sientra Inc.

Received for publication December 13, 2013; accepted January 29, 2014.

Disclosure: Drs. Kinney, Jeffers, and Ratliff are clinical study investigators for Sientra and receive standard research support for conducting their studies. Mr. Carlisle is a Sientra employee.

Brian M. Kinney, MD, Department of Plastic Surgery, USC School of Medicine, 120 South Spalding Drive, Suite 330, Beverly Hills, CA 90212,

©2014American Society of Plastic Surgeons