I think you've fallen for the BS that his implant is FDA approved. The material is FDA approved and he makes it sound as if he has some kind of special FDA approval for a silicone implant for the penis. It's just a marketing scam. The FDA have approved the silicone material and it can be used freely by surgeons, it's not their fault Elist implants it into the penis. It's no different to using Alloderm in that respect. The FDA have approved Alloderm and some surgeons choose to use it on the penis.
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