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Assessment of silicone gel breast implant biodurability by NMR and EDS techniques
Author(s) -
Taylor R. B.,
Eldred D. E.,
Kim G.,
Curtis J. M.,
Brandon H. J.,
Klykken P. C.
Publication year - 2007
Publication title -
journal of biomedical materials research part a
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.849
H-Index - 150
eISSN - 1552-4965
pISSN - 1549-3296
DOI - 10.1002/jbm.a.31589
Subject(s) - silicone , silastic , materials science , breast augmentation , silicone oil , elastomer , implant , silicone elastomers , biomedical engineering , composite material , surgery , medicine
In a study using explanted gel breast implants and appropriate nonimplanted controls, we examined silicone biodurability after long‐term implantation. Using NMR spectroscopy, as well as NMR relaxometry measurements ( T 2 ), no evidence of hydrolysis or other chemical degradation of the cross‐linked silicone matrix was observed in specimens from an early breast implant model (Cronin) explanted after 32 years in vivo or a more recent Silastic® II model after 13 years in vivo . In addition, no appreciable differences were seen in T 2 relaxation times comparing explanted breast implants to suitably‐matched nonimplanted controls, further underscoring the biostability of the cross‐linked silicone shell and gel. Our T 2 data and resultant interpretations differ from a 2004 report by the NMR lab at the University of Münster, highlighting the importance of suitable nonimplanted controls and sample preparation. Energy dispersive spectroscopy (EDS) was also performed, confirming the persistence of a fluorosilicone layer inside the elastomer shells of Silastic II implants. © 2007 Wiley Periodicals, Inc. J Biomed Mater Res, 2008