Silicone Gel Bleed

Silicone gel is made up of a sponge-like mesh filled with silicone in oil form. This oil is used in many medical products such as syringles, pills, and anti-gas medications such as Mylanta. It is known that some very small amounts of the oil part of the gel “bleeds” through the implnat’s shell. Although most of this stays in the implant pocket or is trapped in the surrounding capsule, minute amounts of this silicone could possibly migrate to different parts of the body.

Small quantities of low molecular weight (LMW) silicone compounds, as well as platinum (in zero oxidation state), have been found to diffuse (“bleed”) through an intact implant shell. The evidence is mixed as to whether there are any clinical consequences associated with gel bleed. For instance, studies on implants implanted for a long duration have suggested that such bleed may be a contributing factor in the development of capsular contracture and lymphadenopathy. However, evidence against gel bleed being a significant contributing factor to capsular contracture and other local complications is provided by the fact that there are similar or lower complication rates for silicone gel-filled breast implants than for saline-filled breast implants. Saline-filled breast implants do not contain silicone gel and, therefore, gel bleed is not an issue for those products. Furthermore, toxicology testing has indicated that the silicone material used in Allergan’s implants does not cause toxic reactions when large amounts are administered to test animals. It should also be noted that studies reported in the literature have demonstrated that the low concentration of platinum contained in breast implants is in the zero oxidation (most biocompatible) state.