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pps proceeding
Symposium: S13 - Polymer Materials for Medical Applications
Keynote Presentation
 
 

Failure of Silicone Breast Implants - Novel Insights on the Mechanical Properties of Implant Shells

Schubert Dirk W. (1)*, Horch Raymund E. (1), Kaschta Jochen (1), Daenicke Jonas (1), Walter Bastian (1), Lämmlein Michael (1), Werner Siegfried (1), von Hanstein Harald (1)

(1) Friedrich-Alexander University Erlangen-Nürnberg - Bayern - Germany

This talk summarizes the knowledge on rupture of gel-filled silicone breast implants which is an open question since the first implantation in 1962. We present recent progress which was made by a mapping of the mechanical properties of the shell material together with a statistical failure analysis by means of a Weibull fit considering cyclic loading and various textures of the implant shell surface. Reference implants and intact as well as ruptured explants are tested after several years in vivo by tensile tests. Up to 110 dumbbell-shaped specimens per implant are measured allowing a detailed mapping of the mechanical properties of the silicone shell. Therefore, it is possible to illustrate the obtained results of the tensile tests by mapping the measured values of the implants in form of a contour plot revealing novel insights. The contour plots clearly reveal that the mechanical behaviour (e.g. stress at break) varies significantly over the shell. Additionally, a map is proposed which clearly shows separated clusters for the different manufacturers and product categories indicating a large variety of shell resilience. In particular we make firstly an attempt to mirror effects on implants under conditions during the use under a bulletproof vest. As a remarkable result e.g. it turns out that most implants are resilient up to a load of typically 1500 kg. References 1. Schubert, D. W.; Kaschta, J.; Horch, R.E.; Walter, B.; Denicke, J.; “On the failure of silicone breast implants – new insights by mapping of the mechanical properties of implant shells” review to be published 2. Bachelor Thesis, Werner, S. , Friedrich-Alexander University Erlangen-Nuremberg 3. Bachelor Thesis, Lämmlein, M. , Friedrich-Alexander University Erlangen-Nuremberg 4. Bachelor Thesis, Daenicke, J. , Friedrich-Alexander University Erlangen-Nuremberg 5. Master Thesis, Walter, B., Friedrich-Alexander University Erlangen-Nuremberg 6. Patent EP 15197017.05 Schubert, D. W et al