Cyclic volatile methylsiloxanes in human blood as marker for ruptured silicone gel-filled breast imp

The use of low quality silicone material in silicone gel-filled breast implants (SBI) of the manufacturers Poly Implant Prothèse and Rofil Medical Nederland B.V., as reported in 2010, demonstrates the need for non-invasive, sensitive monitoring and screening methods. Up to this date imaging methods, like mamma sonography (SONO) and magnetic resonance imaging (MRI), are used as diagnostic tool for detection of defect SBI. Under the financial point of view in health system SONO, which is a much cheaper, but less precious than the “gold standard” MRI, is the commonly used clinical method. The aim of this work is the development of an analytical, non-invasive method based on blood analysis for the identification of ruptured SBI, which is more accurate than SONO.

We developed a novel, sensitive method based on large volume injection-gas chromatography coupled to mass spectrometry to determine octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclo-hexasiloxane (D6) in blood samples of women with intact and ruptured silicone breast implants. In this study, it was the first time that a correlation between siloxane-blood-concentration and the operative evidence of SBI could be observed. Compared to the SONO diagnostic results a higher precision with an error rate of 17 % with the developed analytical diagnostic method instead of 46 % was achieved.

Bleeding process from silicone gel through the silicone elastomer shell into surrounding the tissue

Work was done by Pia Rosendahl