> Like many others, Elist then took advantage of a regulatory loophole in seeking the FDA’s blessing. Known as a 510(k) clearance, it sets aside the requirement of a full safety review for biomedical inventions determined to be “substantially equivalent” to products that were on the market before the passage of new federal regulations on medical devices in 1976. Elist argued that his implant was similar to the silicone implants long used in ear, nose, and throat surgeries. The FDA agreed in 2004, granting Elist permission to begin implanting the device “for use in the cosmetic correction of soft tissue deformities.” Deformity, Elist believes, lies in the eye of the beholder. He began advertising his invention, named the Penuma at his son Jonathan’s suggestion, as the “first FDA-cleared penile implant for cosmetic male enhancement.”
To me, the most interesting thing in this story is actually that Elist is selling potentially dangerous implants outside the scope of his FDA approval. Even though he only has clearance to use it for "deformities", he's marketing it for the purpose of "enhancement".