Is Biorevitalization FDA Approved? Skin Treatment

Did you know the FDA has only approved one dermal filler that stays in the body? This makes us wonder about treatments like biorevitalization. With the skincare market growing from $37.1 billion in 2022 to $45.6 billion by 2026, it’s key to know if these treatments are safe and effective.

Biorevitalization is a skin treatment that uses vitamins and plant extracts to make skin look younger. It aims for long-term results, not just immediate volume changes. But does the FDA recognize and support this treatment? We need to look closely at the safety and side effects of biorevitalization to understand its place among FDA-approved treatments.

Unlike some fillers that last months or years, biorevitalization might need several treatments every 10-15 days, twice a year. While some fillers are FDA-approved, we must be careful not to confuse them with biorevitalization. This treatment might use different materials or methods that aren’t approved yet.

Key Takeaways

• Only one dermal filler product approved by the FDA is non-absorbable and remains in the body.
• The skincare market is projected to grow significantly, stressing the need to understand biorevitalization safety and efficacy.
• Biorevitalization involves multiple sessions, contrasting with the generally longer-lasting effects of dermal fillers.
• Some materials used in biorevitalization are similar to those in FDA-approved fillers, though techniques and combinations can differ.
• Understanding the FDA approval status of skin treatments helps ensure safety and effectiveness.

Understanding Biorevitalization: What Is It?

The biorevitalization procedure, also known as “biorejuvenation,” is a blend of cutting-edge skin rejuvenation techniques. It fights aging’s effects. This anti-aging skin treatment uses vitamins, enzymes, hyaluronic acid, and plant extracts. These are injected into the skin to boost and refresh tissue at a cellular level.

What is Biorevitalization?

Biorevitalization uses biological substances to boost the skin’s natural healing and repair. Studies, like those by Galadari and Al Faresi (2011), show its value in skincare. The biorevitalization procedure enhances skin moisture, elasticity, and glow.

How Does Biorevitalization Work?

The process injects tiny amounts of special solutions into the skin’s deeper layers. Techniques like Gold Microinfusion use approved ampoules for accurate delivery. This improves skin elasticity and reduces pores.

Ingredients in the solutions boost collagen and elastin production. These proteins are key for young-looking skin.

Research by Savoia et al. (2013) shows the success of minimally invasive facial treatments. The biorevitalization procedure offers quick results and ongoing benefits. It makes skin look brighter and improves over time with collagen stimulation.

FDA Approval Status of Biorevitalization

The FDA approval of biorevitalization is complex. Some parts of it, like hyaluronic acid and vitamins, are approved for skin treatments. But, the full treatment isn’t universally approved.

FDA approval comes from strict clinical studies. These studies check if the treatment works and is safe. Biorevitalization is hard to get full FDA approval because it’s customized for each person. It uses things like hyaluronic acid, found in approved fillers, but also other parts not yet approved.

Profhilo is an example, using eight injections in the lower face. You need two sessions, six weeks apart. After three to four weeks, the results last up to six months. Teoxane Redensity 1 uses pure hyaluronic acid and other ingredients for skin hydration. This shows the difference between biorevitalization safety and full FDA-approved treatments.

Talking to a doctor can help decide on treatments like Teoxane Redensity 1, Profhilo, or others. Here’s a table comparing FDA-approved parts and their roles in skin treatments:

Doctors and patients must think about the risks and benefits of biorevitalization. Studies since 2009 have shown its potential, but it’s not fully approved yet.

This shows why it’s key to know the difference between approved parts and full biorevitalization treatments. This ensures patients are safe and get good results.

Biorevitalization vs Dermal Fillers

Biorevitalization and fillers both aim to make the skin look younger. But they use different materials and have different effects.

The choice between them depends on the materials used and how safe they are.

Key Differences

Biorevitalization uses hyaluronic acid gel, like Skinvive by Juvederm, which is approved for certain areas. It takes about 15-20 minutes and might need 2-4 syringes per session. The effects last up to six months.

Dermal fillers, like Restylane, have been used longer and give longer-lasting results. They are more widely approved by the FDA.

In places like Asia and Europe, biorevitalization is popular for making skin look better. But not all biorevitalization treatments are fully approved in the US. It’s important to know about the safety and approval of biorevitalization.

Materials Used in Both Treatments

Both biorevitalization and fillers often use hyaluronic acid. This substance is important for keeping skin hydrated and structured. Skinvive by Juvederm is a type of biorevitalization that uses this acid a lot.

Dermal fillers use different materials, such as:

• Hyaluronic Acid (e.g., Restylane)
• Calcium Hydroxylapatite (e.g., Radiesse)
• Poly-L-lactic Acid (e.g., Sculptra)
• Polymethylmethacrylate (PMMA; e.g., Bellafill)

Each material has its own benefits and how long it lasts. Some fillers work right away, while others help make more collagen over time. But, it’s important to think about the safety of biorevitalization, like the risk of bruising or skin infections.

Restylane, a hyaluronic acid filler, was the first to get FDA approval in the US in 2003. This approval helped set standards for safety and effectiveness in fillers and biorevitalization treatments.

Choosing between biorevitalization and fillers should be based on what you want and what a professional recommends. Make sure to consider the safety and effectiveness of each option.

Procedure of Biorevitalization Treatment

The biorevitalization procedure is a popular, non-surgical skincare treatment. It rejuvenates the skin, adds hydration, and fights aging signs. This method uses microinfusions with a special mix, made just for your skin’s needs. Let’s look at how it’s done and the tools and techniques used.

Step-by-Step Process

Here’s how the biorevitalization procedure works for the best results:

1. Initial Consultation: Your skin type and condition are carefully checked.
2. Treatment Planning: A special mix is made just for you, with things like hyaluronic acid, vitamins, and minerals.
3. Preparation: Your skin is cleaned and a numbing cream might be applied if needed.
4. Microinjections: The special mix is injected into your skin with fine needles or special devices.
5. Post-Treatment Care: You’ll be told to use sunscreen, avoid makeup, and follow certain steps to get the best results.

Tools and Techniques Used

The success of the biorevitalization procedure comes from the tools and techniques used:

1. CE Marked and FDA-Approved Devices: These devices are precise and safe.
2. High-Viscosity Hyaluronic Acid: It’s mixed with vitamins in a special ratio to hydrate the skin well.
3. Immunofluorescence Staining: This method uses infrared staining to find collagen and elastin for better treatment.
4. Customized Cocktails: The mix is made just for you, to fix things like uneven skin tone, aging, or scars from acne.

Studies show that the techniques used in biorevitalization work well. For example, a study with six women used a mix of hyaluronic acid and vitamins over six weeks. The skin looked better in texture and was tighter, even though collagen and elastin levels didn’t change much.

The biorevitalization procedure is a top choice for making skin look young and glowing. It uses the latest tools and techniques for a natural look.

Benefits of Biorevitalization

When looking at anti-aging skin treatments, biorevitalization stands out. It’s known for its gentle way of making skin look younger and more hydrated. A big plus of biorevitalization is how it boosts skin moisture, making it look fresh and young. The PRX-T33® peel is a great example, supported by many studies.

The PRX-T33® peel is FDA-approved and uses special ingredients like Trichloroacetic Acid, hydrogen peroxide, and Kojic acid. These ingredients help with acne scars, big pores, and uneven skin tone. Right after the treatment, your skin will look brighter and more radiant.

Another great thing about the PRX-T33® peel is you can do it any time of the year without worrying about sunburn. It’s a no-needle treatment that helps your skin regenerate deeply without removing the top layer. It works for all skin types and ages, and you’ll see results fast with little downtime.

Hydrogen peroxide in the peel cleans the skin by releasing oxygen, fighting germs. Kojic acid reduces melanin, helping with freckles and acne marks. You’ll see your skin tightening up after just a few treatments.

The PRX-T33® technique stimulates collagen growth without harming the skin’s surface. This makes biorevitalization a top choice for many skin problems. It’s a trusted, effective, and science-backed way to fight aging skin.

Potential Side Effects of Biorevitalization

Biorevitalization treatments are known for making the skin look younger. But, they can also have side effects. It’s important to know about both common and serious risks to stay safe.

Common Side Effects

Most people who get biorevitalization might see mild side effects. These include redness, swelling, bruising, and tenderness where the shots were given. After the treatment, some might feel a bit uncomfortable, like with other skin treatments. These issues usually go away in a few days.

Serious Risks and Precautions

Even though serious problems are rare, we need to talk about them. Allergic reactions and infections can happen, especially if the products aren’t tested well. The Korea FDA has approved some products, but not all used in biorevitalization are okay in the U.S.

• Proper administration of the treatment
• Effective monitoring post-procedure
• Maintaining open communication with healthcare providers
• Early detection and management of symptoms

If you’re thinking about biorevitalization, talk to a licensed healthcare provider. They can help you understand the risks and make sure the products are safe.

Who is a Candidate for Biorevitalization?

Biorevitalization is a popular skin treatment that boosts hydration, texture, and looks. It’s great for many people. This section will look at who’s a good fit and who should think twice before trying it.

Ideal Candidate Criteria

Many people can get biorevitalization, making it a great choice for lots of skin types. The main criteria are:

• Individuals looking to enhance skin hydration
• People with decreased skin elasticity and fine lines
• Patients aiming to revitalize stressed skin
• Individuals who wish to counteract the effects of UV exposure
• Young patients desiring preventive care

Those over 18, not pregnant or smoking, without health issues, are usually good candidates. New treatments like SKINVIVE, the first FDA-approved hyaluronic acid filler in the U.S., set high standards. SKINVIVE treatments last six to nine months, sometimes needing touch-ups.

Contraindications

But, there are some things to watch out for:

• Allergies to treatment substances, particularly hyaluronic acid
• Active skin infections or inflammatory conditions
• Pregnancy and breastfeeding
• Patients with autoimmune diseases

It’s important to talk to a qualified provider before starting. They can check if you’re a good fit and follow FDA guidelines for fillers.

Here’s a quick look at SKINVIVE and biorevitalization:

Right after one session, you can see results, making it popular among many.

Biorevitalization Before and After: What to Expect

When thinking about biorevitalization, knowing what to expect before and after is key. This treatment helps make the skin look younger by boosting collagen production. It also improves skin quality and fixes different cosmetic issues.

Immediate Results

Right after a biorevitalization treatment, the skin looks brighter and smoother, known as the “Gold effect.” It might seem more hydrated and fuller. These quick changes depend on the products used, like FDA-approved fillers like Juvederm XC or Sculptra. Sculptra, approved in 2014, helps skin get better over time by making more collagen.

Long-term Benefits

Over time, biorevitalization keeps making more collagen, making skin tighter and more elastic. Skin texture and color keep getting better. Products like Radiesse and PRX-T33 help by making more collagen and rejuvenating the skin gently. Studies show Sculptra can last over two years, making skin look younger by reducing lines and wrinkles.

It’s important to set realistic expectations with biorevitalization. Results can differ from one person to another. Many people see big improvements in their skin, but there aren’t many studies to back this up. Still, using FDA-approved products means the treatment is safer and more likely to work.

Conclusion

Biorevitalization is a new and exciting way to improve skin, but it’s not fully approved by the FDA. Some parts of it might be okay, but the whole thing isn’t. WiQo PRX-T33, for example, has been approved since September 2019 and has helped millions of people worldwide.

It’s important to talk to doctors before trying biorevitalization. They can tell you how it might affect your health. This is key for anyone thinking about it.

Even though there’s not enough proof yet, some people say it works. But we need more studies to be sure. So, it’s best to follow FDA advice and pick a trusted provider.

PRX-T33 can be used on different parts of the body, not just the face. You can get it any time, even when it’s sunny. So, if you’re looking into skin treatments, do your homework, talk to experts, and follow the safety rules.