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Bioengineering (Basel). 2019 May 12;6(2). pii: E43. doi: 10.3390/bioengineering6020043.

New Evaluation Procedure for Multi-Dimensional Mechanical Strains and Tangent Moduli of Breast Implants: IDEAL IMPLANT® Structured Breast Implant Compared to Silicone Gel Implants.

Author information

1
Department of Mechanical Engineering and Materials Science, Washington University, St. Louis, MO 63130, USA. hjb@wustl.edu.
2
Pacific Center for Plastic Surgery, Newport Beach, CA 92660, USA. lnichter@imagedr.com.
3
Department of Plastic Surgery, University of California Irvine, Irvine, CA 92868, USA. lnichter@imagedr.com.
4
Medical Device Pros, LLC, Satellite Beach, FL 32937, USA. dback@MedicalDeviceProsLLC.com.

Abstract

The IDEAL IMPLANT® Structured Breast Implant is a dual lumen saline-filled implant with capsular contracture and deflation/rupture rates much lower than single-lumen silicone gel-filled implants. To better understand the implant's mechanical properties and to provide a potential explanation for these eight-year clinical results, a novel approach to compressive load testing was employed. Multi-dimensional strains and tangent moduli, metrics describing the shape stability of the total implant, were derived from the experimental load and platen spacing data. The IDEAL IMPLANT was found to have projection, diametric, and areal strains that were generally less than silicone gel implants, and tangent moduli that were generally greater than silicone gel implants. Despite having a relatively inviscid saline fill, the IDEAL IMPLANT was found to be more shape stable compared to gel implants, which implies potentially less interaction with the capsule wall when the implant is subjected to compressive loads. Under compressive loads, the shape stability of a higher cross-link density, cohesive gel implant was unexpectedly found to be similar to or the same as a gel implant. In localized diametric compression testing, the IDEAL IMPLANT was found to have a palpability similar to a gel implant, but softer than a cohesive gel implant.

KEYWORDS:

IDEAL IMPLANT; breast implant; breast implant dimensions; breast implant evaluation; breast implant mechanical properties; breast implant rupture; breast implant testing; capsular contracture; compression; dual lumen; silicone gel; strain; structured; structured saline breast implant; tangent modulus

Conflict of interest statement

H.J.B. and D.D.B. were consultants to Ideal Implant Incorporated for this study, and were independently responsible for the study design, execution, data analysis and interpretation on the project, and for writing the manuscript. L.S.N. is a clinical trial investigator for “Core Study of the Safety and Effectiveness of IDEAL IMPLANT® Saline-filled Breast Implants,” ClinicalTrials.gov NCT00858052. The authors declare no conflicts of interest.

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