A method to measure gel bleed from intact silicone gel-filled breast implants was developed. This nondestructive technique permits accurate and reproducible serial measurements of silicone bleed from smooth wall breast implants (n=10) under simulated physiologic conditions in vitro. Gel bleed rates from new low bleed gel-filled implants and intact explants (unbarriered, low bleed, double lumen) were determined. These results demonstrate the reliability of this method to quantify silicone gel bleed and may permit a meaningful comparison of bleed rates from implants in the future.
A commercially available mammary implant containing a soft polyester polyurethane foam shell has been examined for possible diamine hydrolysis products. Fourier Transform Infrared (FT-IR) analysis has shown ester and aromatic structures present in the intact foam shell. Vigorous hydrolysis conditions using NaOH have produced a mixture with large amounts of toluene diamine (TDA) present as determined by Gas Chromatography-Mass Spectrometry (GC/MS), and GC/FT-IR. There are numerous clinical reports of the degradation of this implant shell after implantation with incorporation of fragments into phagocytic cells at the implantation site. Recent reports have discussed late pain and other allergic reactions to this implant. Release of the known toxic material, TDA, is consistent with these observations and strongly suggests that an alternative material be used in this application.
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