Implant Testing and the "Strain Energy" Concept

Abstract

Benchtop performance test methodologies differ between manufacturers as regulatory agencies often leave the interpretation of testing standards up to manufacturer discretion, resulting in an inability to directly compare implants across manufacturers. Furthermore, traditional benchtop test methodologies focus on mechanical performance standards to address objective endpoints such as shell strength. However, other more difficult to define clinical performance requirements such as softness and natural feel are often difficult to measure via these methods. This review aims to discuss the evolution of breast implant testing standards, discuss the discrepancies in benchtop characterizations of implants, and highlight one manufacturer's novel approach to utilizing benchtop methodologies to quantify previously subjective endpoints such as firmness and natural feel and define their clinical relevance.