Analysis of Silicon Levels in Capsules of Gel and Saline Breast Implants and of Penile Prostheses

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Abstract
Although a potential link between silicone-gel breast implants and autoimmune connective tissue disease has been suggested, none has been proven. The potential role of silicone as an immune adjuvant remains very controversial. Currently available techniques do not allow precise measurements of silicone in tissues. However, all compounds containing silicon (including silicone) can be measured accurately. The present study was designed to measure silicon levels in the fibrous capsules of patients with silicone-gel breast implants, saline breast implants, and silicone inflatable penile prostheses. Baseline control silicon levels were obtained from the breast tissue of patients undergoing breast reduction, who had no exposure to breast implants. All silicon measurements were carried out using atomic absorption spectrometry with a graphite furnace. Silicon was measured in a normal heptane extract of silicone from dried tissue. The mean silicon levels in 16 breast tissue control samples from 8 patients undergoing breast reduction varied from 0.025 to 0.742 μg/gm with the median mean being 0.0927. The median silicon level in capsules from six patients with saline implants was 7.7 μg/gm (range, 1.9–36.6 μg/gm). The median silicon level in capsules from five patients with silicone inflatable penile prostheses was 19.5 μg/gm (range, 1.9–34.8 μg/gm). Although the levels of silicon in capsules of patients with saline breast prostheses and penile implants were higher than in control samples, they were much lower than those from the capsules of the 58 gel implants (median, 9,979 μg/gm; range, 371–152,000 μg/gm). Of the 58 silicone-gel breast implants (from 20 patients with bilateral implant removal and 18 patients with unilateral removal) that had been inserted from 1974 to 1990, 28 were intact, 8 had pinhole leaks, and 22 were ruptured. Median capsule silicon levels and ranges for all 58 implants, for intact only, for leaking, and for ruptured were, respectively, as follows: 9,979 (371–152,000); 10,477 (371–88,703); 6,592 (3,235–65,396); and 9,922 (1,762–152,387) μg/gm. There were no significant differences in silicon levels associated with implant status, duration in situ, or year of implantation.

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