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With such significant profits to be made at a relatively low risk, there is a tremendous incentive for counterfeiters to tap into the growing market for PDE-5i. Two separate analyses in Europe estimated that 0.6 to 2.5 million men are being exposed to illicit sildenafil compared to approximately 2.5 million users of legal sildenafil (8). Between 2004 and 2008, 35.8 million counterfeit sildenafil tablets were seized in Europe, which is 7 times greater than the amount of all other counterfeited Pfizer products combined. Key Takeaways No clinical evidence supports the claim that pills can permanently enlarge the penis. Physician should have low threshold in prescribing for erectile dysfunction medication and to carefully monitor patients who are at risk of developing ED in the future to encourage more open conversation about this topic and eliminate the stigma of ED. Nevertheless, FDA faces serious obstacles in identifying these products true ingredients in a timely fashion to prevent physical damage being done to general public.