Hyaluronic acid (HA) fillers have been FDA approved for use in the US since 2003 and PMMA since 2006. No one knows exactly when these fillers were first used to make the first penis bigger, but we do know that penile enhancement for girth is an increasingly popular procedure. When considering any procedure but especially one with such a direct impact on a man’s health, it is important to consider the FDA approval status of the proposed treatment. At GetMoreGirth, we use Voluma, Volux and Bellafill, all of which are FDA-approved dermal fillers. It is important to understand that their use for penile enhancement is off-label. Here we will explain what FDA approval means,  and what off-label use means and why it’s so important to use FDA approved products.

FDA Approval

The Food and Drug Administration (FDA) regulates the use of drugs and medical devices in the US to ensure product safety and efficacy. Dermal fillers are considered medical devices by the FDA. FDA approval ensures that the medication or device has undergone rigorous testing and clinical trials to meet strict standards for both efficacy and for safety.

At GMG We Use Only FDA Approved Fillers

At GMG we only use FDA approved fillers because we know they have undergone this rigorous testing.  We are, however, using the fillers in an off-label fashion. What exactly does off-label mean? Off-label use refers to when an FDA-approved medication or devices is used for a purpose that was not explicitly studied during the approval process of the product. This means that while the product is approved for certain uses, it is being used in a different way; a way that has not been specifically studied or approved by the FDA.

Is This Common?

Off-label use is legal and common in the practice of medicine. Physicians use their clinical judgment and expertise so they can use a device or medication for the benefit of their patients, even if those treatments are not specifically approved for that use.  There are many examples of this. For instance, antidepressants are used to treat chronic pain, and certain cancer drugs are used to treat types of cancer other than those for which they were originally approved. Did you know that aspirin is not FDA approve to treat a heart attack but of course doctors use it all the time for this purpose.  It is estimated that up to a third of all prescriptions are being used in an off-label indication

Off-Label Use of Voluma and Bellafill for Penile Enhancement

Why Off-Label?

Currently, there are no dermal fillers specifically approved by the FDA for penile enhancement. However, the properties of Voluma, Volux and Bellafill make them suitable for this purpose due to their ability to add volume and stimulate collagen production. It’s not a huge leap to understand that if fillers can volumize in one location they can do it in another.

Safe Use Off-Label Use of Fillers

The safety of off-label use largely depends on several factors. The first and foremost is   the knowledge of the physicians performing the procedure. At GetMoreGirth, Dr. Sullivan is highly experienced. He has been using fillers for over 20 years and specifically treating the penis for half a decade. Even though this use is off label, it’s important that only FDA approved fillers are used. Using FDA-approved products ensures that the fillers themselves meet high standards of safety. There are some unscrupulous practices that use non-FDA approved products. At GMG we believe that if a U.S provider tells you they are using “proprietary” fillers or if they will not tell you exactly what they are using you should run. “Proprietary” fillers are often sold as unique or custom, but in truth it is usually a cost cutting measure for the provider. You will be getting a little studied, unknown product injected into you as a cost saving measure.  A reputable provider will always be clear about the products they use. If a provider is unwilling to disclose the specific FDA-approved filler being used, it raises big red flags about the legitimacy and safety of the treatment. 

Risks of Leaving the Country for Treatment

Regulatory Standards: 

Countries outside the U.S. have different and often less stringent standards for medical treatments and products. This means that when you leave the country you are using fillers that are not as thoroughly tested for safety and effectiveness as FDA-approved fillers.

Follow-Up Care:

Aftercare is crucial for any medical procedure, including penile  enhancement. When you travel abroad for treatment, follow-up care becomes challenging. Complications or side effects might arise after you return home. It’s more difficult to manage these from another country. Also, many physicians in the U.S will be reluctant to assist as they will understandably feel like this if someone’s else’s “problem.”

Avoid the temptation, and it is a big one, to save money by seeking treatment abroad or from providers using “proprietary” fillers. These options may cost you more in the long run. 

Are the Fillers Used for Penile Enhancement FDA approved?

Are the dermal fillers used for penile enhancement FDA approved? At GetMoreGirth the answer is always YES! Penile enhancement with dermal fillers using FDA-approved products such as Juvéderm Voluma and Bellafill is a safe and effective method to increase penile girth. While these fillers are being used off-label for penile enhancement, their safety and efficacy are well-established in their FDA-approved uses. The off-label use of these fillers is a legal and common practice in medicine, guided by the expertise and clinical judgment of experienced medical professionals like Dr. Sullivan.

You should maximize your safety by choosing FDA-approved products and selecting a board-certified physician, like Dr. Sullivan. By doing this you can achieve significant girth gains and lasting enhancement with confidence. 

The journey to a more confident you starts with one decision. At GetMoreGirth  we are here to help. If you have any concerns, don’t hesitate to reach out to us – we’re here to make you your best!