Browsing Articles and other publications by RIVM employees by Authors
Poly Implant Prothèse Silicone Breast Explants: Chemical Analysis of Silicone Gel and Implant Shell.Bachour, Yara; Heinze, Zavira; van Selms, Gijs; Ritt, Marco; Niessen, Frank; Keizers, Peter (2019-01-01)Poly Implant Prothèse (PIP) silicone breast implants were removed from the market between 2010 and 2012 because of the use of nonmedical grade silicone filler. The chemical and physico-chemical properties of PIP implants have been analyzed by several groups. In addition, our previous study illustrated that PIP implant shells were more permeable. Therefore, we analyzed the chemical composition of the envelope and gel of PIP silicone breast explants. Also, the composition of absorbed material into the implant was analyzed. This study was conducted on 3 PIP implants explanted from 2 patients. The envelope was analyzed using Raman microscopy, whereas the gel was analyzed using near-infrared spectra, nuclear magnetic resonance spectroscopy, and gas chromatography coupled to mass spectrometry. Absorbed material was investigated with Fourier-transform infrared spectroscopy and sodium dodecyl sulfate polyacrylamide gel electrophoresis. The 3 implants appeared to be Rofil implants, and all implants displayed a yellow color. None of the envelope showed a barrier layer. Amounts of D4, D5, and D6 were found to be below 100 ppm. Water was found in all 3 implants and also proteins were absorbed into the implants. The current study shows that the analyzed implants originate from the manufacturer Rofil but have PIP1 hallmarks. Apparently, these are own brand labeling implants. The presence of water and proteins in the explants indicate exchange of small and large molecules into the explants, even in the implant with a visually intact envelope. Because of the PIP1 hallmarks of the Rofil implants, patients with such implants are advised to be counseled by their physicians.