Penile enhancement with dermal fillers aimed at increasing penile girth can enhance sexual confidence and satisfaction. When considering such procedures and deciding where to have the procedure performed, it is critical to ask, “Are the dermal fillers used for penile enhancement FDA approved?” At GetMoreGirth, we use Juvéderm Voluma and Bellafill, both of which are FDA-approved for cosmetic use. It’s important to note that their application for penile enhancement is considered off-label. This guide will explain what FDA approval means, the significance of off-label use, and the safety and efficacy of these fillers.

FDA Approval

The Food and Drug Administration (FDA) is a regulatory body responsible for ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. FDA approval means that a product has undergone rigorous testing and clinical trials to meet strict standards for safety and effectiveness.

We Only Use FDA Approved Fillers at GetMoreGirth

Voluma

Juvéderm Voluma is an FDA-approved hyaluronic acid-based filler. Hyaluronic acid is a naturally occurring substance in the body known for its ability to add volume. Voluma is commonly used for facial volumization. At GetMoreGirth, we use Voluma off-label to “volumize” the penis. The rigorous FDA approval process ensures that Voluma is safe and effective for its approved uses but it also helps ensure safety for non-FDA approved uses..

Bellafill

Bellafill is a long-lasting filler composed of polymethyl methacrylate (PMMA) microspheres suspended in a collagen gel. It provides immediate volume and stimulates the body’s natural collagen production for long-lasting results. It is the longest-lasting FDA-approved filler on the US market. Bellafill is FDA-approved for the correction of nasolabial folds (smile lines) and for the treatment of acne scars. At GetMoreGirth, we use it off-label to stimulate collagen production in the penis.

Off-Label Use: What Does It Mean?

Definition:

Off-label use refers to the practice of using an FDA-approved medication or product for a purpose that is not included in its approved labeling. This means that while the product is approved for certain uses, it is being used in a different way that has not been specifically approved by the FDA.

Is This Common?

Off-label use is legal and common in medicine. Physicians often use their clinical judgment to prescribe treatments that they believe will benefit their patients, even if those treatments are not specifically approved for that use.

Examples:

Many medications and treatments are used off-label in various medical fields. For instance, some antidepressants are used to treat chronic pain, and certain cancer drugs are used for types of cancer other than those for which they were originally approved. It is estimated that up to a third of all medications that are prescribed 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 and Bellafill make them suitable for this purpose due to their ability to add volume and stimulate collagen production.

Clinical Judgment:

Medical professionals use their expertise and experience to determine that these fillers can be safely and effectively used for penile enhancement, even though it is an off-label application.

 How Do You Ensure Safe Off-Label Use of FDA Approved Products?

Experienced Physician:

The safety of off-label use largely depends on the expertise of the physicians performing the procedure. At GetMoreGirth, DR. Sullivan is highly experienced and trained in using these fillers for penile enhancement.

Quality Control:

Using FDA-approved products ensures that the fillers themselves meet high standards of safety Are the Dermal Fillers Used for Penile Enhancement FDA Approved?

When considering penile enhancement with dermal fillers, it’s crucial to ensure the treatment is safe, effective, and uses FDA-approved products. Opting for FDA-approved fillers provides a layer of assurance about the quality, safety, and effectiveness of the procedure. However, some patients might be tempted to leave the country for treatment or choose a U.S. provider who uses “proprietary” fillers. Here’s why these options can be risky:

The Importance of FDA Approval

The FDA approval process for dermal fillers involves rigorous testing and clinical trials to ensure their safety and efficacy. This means that fillers approved by the FDA have been thoroughly evaluated for their ability to provide consistent results without significant adverse effects. Using FDA-approved fillers ensures that the product has met high standards and is supported by scientific evidence. Always be sure to ask yourself before an augmentation procedure: Are the Dermal Fillers Used for Penile Enhancement FDA Approved?

 Risks of Leaving the Country for Treatment

1. Regulatory Standards: Countries outside the U.S. may have different or less stringent regulatory standards for medical treatments and products. This can lead to the use of fillers that are not as thoroughly tested for safety and effectiveness as FDA-approved fillers.

2. 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, and addressing these issues without the original treating provider can be difficult.

Risks of Using “Proprietary” Fillers from U.S. Providers

1. Unknown Composition: “Proprietary” fillers are often marketed as unique or custom formulations, but their exact ingredients may not be disclosed. Without knowing what is in these fillers, you cannot be sure of their safety or how your body will react to them.

2. Lack of Regulation: Fillers not approved by the FDA are not subject to the same regulatory scrutiny. This means their safety, effectiveness, and quality are not guaranteed. Using such fillers increases the risk of adverse reactions and complications.

3. Accountability and Transparency: A reputable provider should always be transparent about the products they use. If a provider is unwilling to disclose the specific FDA-approved filler being used, it raises red flags about the legitimacy and safety of the treatment. Providers who use FDA-approved fillers are more likely to adhere to best practices and provide high-quality care.

When it comes to penile enhancement with dermal fillers, prioritizing safety and effectiveness is paramount. Always ensure that the dermal fillers used are FDA-approved and that your provider is transparent about the products they use. Avoid the temptation to save some money by seeking treatment abroad or from providers using “proprietary” fillers, as these options come with significant risks and uncertainties. By choosing a reputable provider who uses FDA-approved fillers, you can ensure that your treatment is safe, effective, and supported by high standards of medical care. In both of these situations out of the country treatment or the use of “”Proprietary” fillers the answer to: Are the dermal fillers used for penile enhancement FDA approved? Is a resounding NO!

Why useFDA Approved Fillers:

Proven Results:

Both Voluma and Bellafill have shown to be effective in adding volume and enhancing the appearance of the treated area. FDA-approved trials have been done to prove the fillers really work.

Longevity:

Voluma provides results that typically last over two years, while Bellafill offers long-lasting results that can be considered permanent due to ongoing collagen stimulation. This has been demonstrated in FDA-approved trials.

Are the dermal 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.

By prioritizing safety, choosing FDA-approved products, and selecting board-certified physicians, patients can achieve significant and lasting enhancement with confidence and improved sexual satisfaction.

The journey to a more confident you starts with one decision. And if you think girth enhancers or girth shots might be that choice, why wait? If you’re on the fence or have questions brewing, remember: We at GetMoreGirth are always here to help. If you have any concerns, don’t hesitate to reach out to us at GetMoreGirth – we’re here to make you your best!