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Penis enlargement surgery is a risky and expensive method to enlarge the penis.
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Indeed, the FDA — the government agency that regulates medications and medical devices — has never approved any medications or devices for enlarging a penis.
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Pines enlargement surgery - New Doctor InsightsA penile prosthesis is another treatment option for men with erectile dysfunction.
However, your firm is marketing the device for penis enlargement, length and correction of penile curvature, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.