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Silicone gel breast implants: science and testing.

Brian M Kinney1, Lynn L C Jeffers, Gregory E Ratliff

  • 1Beverly 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.

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New breast implant testing reveals significant differences in gel elasticity, fracture resistance, and shell adhesion among brands like Sientra, Allergan, and Mentor. These findings provide objective metrics for evaluating implant performance.

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Area of Science:

  • Biomaterials Science
  • Medical Device Engineering
  • Plastic Surgery Research

Background:

  • Breast implant design has evolved with innovations in gel consistency, shell properties, and barrier materials.
  • Objective metrics for comparing breast implant performance have been lacking for surgeons.

Purpose of the Study:

  • To establish quantifiable metrics for assessing and comparing key performance characteristics of different breast implants.
  • To evaluate gel elasticity, gel-shell adhesion, and structural integrity of leading breast implant brands.

Main Methods:

  • Independent laboratory testing involved four key assessments: gel elasticity, gel compression fracture resistance, gel-shell peel strength, and morphological analysis.
  • Specific tests measured the ability of the gel to retain shape, resist permanent deformation, integrate with the shell, and maintain structural integrity.

Main Results:

  • Sientra's High-Strength Cohesive (HSC) implants showed the least gel elasticity among round implants, while Allergan's had the most. Sientra's shaped implants demonstrated superior resistance to gel fracture compared to Allergan and Mentor Contour Profile Gel (CPG) implants.
  • Sientra implants required significantly greater force in gel-shell peel tests, indicating stronger integration, and maintained structural integrity better than other tested implants.
  • Variations in gel elasticity and fracture resistance were noted between round and shaped implant designs across different brands.

Conclusions:

  • Breast implant characteristics such as gel elasticity and shell adhesion are distinct factors and not always correlated.
  • These objective testing methods provide valuable data to aid clinicians in selecting appropriate breast implants based on specific patient needs and desired outcomes.