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Penuma: The First FDA-Cleared Cosmetic Penile Implant Improving Men’s Sexual Lives

EntertainmentPenuma: The First FDA-Cleared Cosmetic Penile Implant Improving Men’s Sexual Lives

Despite advances made in sexual positivity, male sexual health remains a taboo subject. Men often silently suffer from sexual issues, afraid to voice these concerns — even to their partners. A man’s sexual health, or his perception of it, can have a significant impact on his ability to lead a fulfilling life. This is why it’s essential to not only cultivate openness about these issues but also to find solutions.

Fortunately, there’s a male enhancement solution called Himplant, the evolved successor to the original game changer, Penuma. Developed by Dr. James Elist, it’s the first Food and Drug Administration-cleared solution for penis enlargement on the market. It’s a medical-grade silicone implant inserted under the penile skin through a surgical incision under the scrotum, offering instant gains in girth. Recent studies have shown that it can be used to treat mild to moderate erectile dysfunction and Peyronie’s disease; it can also help boost the self-esteem of men who may not suffer from any condition but may nonetheless be convinced that their penis is somehow inadequate.

“This is very important for them, changing the size of their penis for any kind of reason,” notes Elist. “For some people, they have low self-confidence or low self-esteem. They have a curvature, their erection is not as good as it used to be, and the changing size in general because the size of the penis after age 35, 40 decreases gradually with age.

“Their manhood, the size of their penis, is very, very important for them. That low self-confidence and self-esteem has a major effect in their life, and in their marriage, and in their sexual relationships.”

And that’s why Elist’s Penuma — or now Himplant — is life-changing.

“The inception of the Penuma implant and its subsequent evolution into the Himplant was driven by the noticeable void in effective solutions for men experiencing distress over their penile size and functionality,” Elist told Authority Magazine. “This gap not only signaled a clinical challenge, but a deeper, more personal plight that needed addressing, inspiring the creation of these implants to offer renewed hope and confidence to those seeking enhancement solutions.”

Dr. James Elist: ‘Securing FDA Clearance Was Pivotal’

For most men, how their penis looks can have a significant effect on their confidence. The shape and size of a penis can be genetic; for instance, a man may naturally have a curved penis. In other cases, the size of the penis may be affected by diseases, or an injury may cause a person to develop Peyronie’s disease. As a result of this ailment, the penis may develop scar tissue, shortening during an erection, or curvature. A man may also have erectile dysfunction. And there are still others who may suffer from penile dysmorphic disorder, a form of body dysmorphia focused on the shape and size of the penis. Suffering from PPD or any of these issues can cause men great stress, leading to various mental health and anxiety issues.

As an improved evolution of Penuma, what truly sets Himplant apart is the fact that it’s been cleared by the FDA. Securing an FDA clearance means a product has been reviewed extensively by FDA for its intended use.

“Securing FDA clearance was pivotal, ensuring the product met the highest standards, crucial for gaining trust in an industry fraught with questionable practices. This step was more than a regulatory necessity; it was a testament to the product’s legitimacy and a foundation for broader acceptance,” Elist told Authority Magazine.

Those familiar with regulatory requirements know how difficult it is to comply. Regulations, especially those by the FDA, are complex and exacting because they’re designed to ensure safety.

Those seeking an FDA clearance must submit an application that outlines the specifics of the product. Submitting the application and the data isn’t the end of the matter; a period of intense scrutiny by the FDA follows, which can last from a few months to a few years.

“I remember the initial submission of documentation for clearance, naively expecting a swift review process. The reality was a series of revisions, additional data requests, and prolonged waiting periods,” recalled Elist.

Securing the FDA clearance isn’t Elist’s only achievement. What truly brings him joy is making a positive difference in the lives of his patients and being recognized for the transformative work he’s doing. His product has been peer-reviewed and withstood the scrutiny of medical professionals. Since his early days, more and more medical professionals have been reaching out to him to be trained in the technique, and this recognition is a milestone achievement.

“Honestly, it was my dream that one day my procedure could be done in Harvard University, and it happened,” he said.

When asked if he could inspire a movement that would bring the most good to the most people, he said, “The establishment of an international body dedicated to making surgical innovation and safety protocols and medical knowledge easily accessible in every country. This organization’s core mission would be to streamline the global distribution of cutting-edge surgical technologies and ensure that safety standards are universally upheld, transcending the cumbersome bureaucracy that currently hampers accessibility.”

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