Chemical fingerprinting of silicone-based breast implants

•Qualitative discriminants of silicone breast implants are described.•Breast implants are distinguished on brand and type.•Barrier layers in breast implant envelopes are visualized.•A set of complementary spectroscopic techniques is described for market surveillance of breast implants. With millions...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2015-01, Vol.102, p.340-345
Main Authors: Keizers, Peter H.J., Vredenbregt, Marjo J., Bakker, Frank, de Kaste, Dries, Venhuis, Bastiaan J.
Format: Article
Language:English
Subjects:
Breast Implants - standards
Female
Humans
Magnetic Resonance Spectroscopy - methods
PIP
RAMAN
Silicone implants
Silicones - analysis
Silicones - chemistry
Spectroscopy
Spectroscopy, Near-Infrared - methods
Spectrum Analysis, Raman - methods
Substandard
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Summary:•Qualitative discriminants of silicone breast implants are described.•Breast implants are distinguished on brand and type.•Barrier layers in breast implant envelopes are visualized.•A set of complementary spectroscopic techniques is described for market surveillance of breast implants. With millions of women worldwide carrying them, silicone-based breast implants represent a large market. Even though silicone breast implants already have a history of use of more than 50 years, the discussion on their safety has not yet come to an end. To improve safety assessment, regulatory authorities should have the availability of a set of tests to be able to determine parameters of implant identity and quality. Therefore, the gels and envelopes of various brands and types of silicone-based breast implants have been subjected to infrared, Raman and NMR spectroscopy. We show that by using a combination of complementary spectroscopic techniques breast implants of various origins can be distinguished on typical chemical hallmarks. It was found that typical silicone-based implants display a surplus of vinyl signals in the gel, cyclosiloxane impurities are tolerable at low levels only and a barrier layer is present in the implant envelope. The techniques presented here and the results obtained offer a good starting point for market surveillance studies.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2014.09.008