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Is Voluma Filler FDA Approved?

Is Voluma (By Juvederm) FDA Approved Yet? If Not, Why Not? What Could Be the Concerns? 

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Voluma is here!

+1

This is the only FDA approved filler for deep injections for CHEEK Augmentation to correct age related volume loss in the mid face in adults over the age of 21.

Web reference: http://www.juvederm.com/views

Washington DC Dermatologist
5.0 out of 5 stars 2 reviews

Yay, Voluma is FDA approved. So what?

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It is now 15 years since I have discovered and integrated “cosmetic medicine” into my aesthetic and reconstructive practice. Cosmetic medicine is the developing branch of non to minimally invasive non-surgical options one uses to enhance their aging process. Whether it be peri-menopausal hot flashes or wrinkles, whatever your medical insurer does not pay for and is perceived by you and the medical industry as personal physical or physiologic enhancement is considered “self-pay” and expanding into the Cosmetic Medicine industry. If such enhancements may have a actual biologic change in your body, it must be FDA approved before it can be marketed in the USA. If it is considered inert and does not actively change or stimulate your tissues to change, it may be marketed OTC (over-the-counter).

Voluma, is a volumizing gel which follows a lengthening list of cosmetic medicine options. It falls in a class of “anti-aging” enhancements called Fillers. This particular one is made by Allergan; is FDA approved this month as a hyaluronic acid gel filler for injection deep into the cheek. It has been labeled for cosmetic use but the class of hyaluronic acid gels are used in different medical formulations (therefore paid by insurance) for lubricating the knee joint, refilling the eyeball and other uses.

Cosmetic and medical fillers are used to replace or add volume to tissues which have lost the 3 dimensional mass from aging or trauma. The best and easiest example to understand is a breast augmentation using a saline (salt water) or gel implant in a young small breasted female or woman following pregnancy for cosmetic reasons or a breast reconstruction implant following breast tissue loss for cancer or injury.

Injectible volumizers have been around for 15 or more years and used to build up soft tissue loss, particularly in the face. Since it is biologically active it also stimulates a body’s immune response to create firming and integration, a process you enjoy and therefore choose to purchase. This process is called scar, or collagen formation and induces phases of swelling, bruising and increased circulation to the area and has many typical side-effects associated with any other injury to your tissues including prolonged discomfort, bruising, swelling, lumpiness, deformity, spider-veins, etc which is part of the “package”. The terrific aspect of Voluma is that it is cross-linked (like having more rungs holding a ladder together) so it lasts longer; up to 2 years. Side-effects can therefore last longer too! Another great thing about Voluma is that it is similar to the same molecule made in the body so it degrades with an enzyme, hyaluronidase, if it is not quite right.

Voluma as with other "HA" filler results are immediate but take 2-3 weeks for most of the side-effects and softening to occur. Depending on your metabolism and the site it is injected it will last longer or shorter duration. Since Voluma is highly linked, it is firmer and requires a deeper injection so you will not notice the rounding, lumpiness or irregularities as much as thinner products such as Juvederm. Also misunderstood is that the body's soft tissues are not one large blob but are compartmentalized into smaller areas. This is where the art of injection come in as your physician injecter must understand the anatomy to place these fillers properly.

I hope this has been helpful for you. Since the art of anti-aging and cosmetic medicine is based on science and individualized for you, please be choosey in finding your best Cosmetic MD possible!

All the best,

Dean Kane, MD, FACS

Baltimore Plastic Surgeon
4.5 out of 5 stars 9 reviews

Fillers can help take years off of your appearance and Voluma is the newest available

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Voluma helps to add volume to areas of loss due to fat, bone and muscle loss.  It puts back the "apples" in the cheeks and can be used to reduce jowls and sunken temples.  It received its FDA approval in 2013.  It is made with Hyaluronic Acid, similar to Juvederm and Restylane, but gives more lift.  We've been having amazing success with the product since it's approval.  Seek a Board Certified Dermatologist who is an expert in injectables for a consultation to see if Voluma is right for you.
Best to you.
Chicago Dermatologic Surgeon
5.0 out of 5 stars 4 reviews

Voluma is FDA Approved!

+1
Yes. Voluma is FDA approved. It has been used safely and effectively for years outside of the United States. There are no safety concerns with this formulation. It is an advancement of the formulation of Juvederm Ultra and Ultra Plus, both of which have been used for years in the United States.
Baltimore Dermatologic Surgeon
5.0 out of 5 stars 1 review

Voluma for mid face

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We dermatologists have eagerly been awaiting the FDA approval of Voluma.  Made by Allergan, the makers of Botox and Juvederm, it is the only filler specifically approved for mid face volumizing. Some great things about Voluma: it's made of hyaluronic acid (like Juvederm, Restylane, and Perlane), so it can be dissolved with hyaluronic acid if needed. It's a thicker product designed to lift, so a little goes a long way. Voluma is meant to be placed deep, right on top of the cheekbone, similar to Radiesse. As with all fillers, a board certified dermatologist with cosmetic experience should perform the treatments. 
Miami Beach Dermatologist

JUVEDERM VOLUMA

+1
Yes, Voluma is FDA approved!  Voluma has been released to a select few physicians who possess extensive experience with advanced techniques with dermal fillers.  The product is used for enhancement of the midface/cheek region.  It's effects last up to 2 years, which is a dramatic improvement over most conventional dermal filler products.  Make sure you select a physician with extensive experience and a proven track record.

Best of luck!

Web reference: http://www.drwise.com/fillers-and-injectables/

Wayne Facial Plastic Surgeon
5.0 out of 5 stars 36 reviews

Voluma Injections in Los Angeles

+1
Our office specializes in Voluma injections into the mid face and cheek to add volume to the area. Voluma is a hyaluronic acid filler which is able to add three dimensional volume to the soft tissues of the face. 

Raffy Karamanoukian MD FACS
Los Angeles Plastic Surgeon
5.0 out of 5 stars 43 reviews

Voluma is FDA Approved

+1
The good news is yes - Voluma is FDA approved. Approved in October of 2013, Voluma is an extension in the Juvederm filler family. This more viscous filler is approved to treat volume loss in the mid face. 

Voluma is a great option to give lift to the mid face and cheek area. This is the only filler that is FDA approved to augment the cheek area. 

Voluma is designed to provide better lift, so it is not appropriate for all areas of the face. Clinical studies show that Voluma may last up to two years. 

Web reference: http://www.mdlsv.com/Treatments/Juvederm

Baltimore Dermatologist
4.0 out of 5 stars 5 reviews

Juvederm Voluma is FDA approved for mid facial lifting

+1
Voluma is FDA approved and has been available for about 7 weeks.  The experience in South America and Europe has been positive and patients and plastic surgeons alike are excited for this product to come to the states.  It is approved for mid facial volume loss and mid face lifting very similar to Radiesse but reversible and lasts longer.  It has been very popular thus far.

Web reference: http://www.northsideplasticsurgery.com

Atlanta Facial Plastic Surgeon
4.5 out of 5 stars 19 reviews

Voluma is the filler most recently approved by the FDA

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Voluma is now approved by the FDA for use in the malar, or cheek region, for soft tissue volumization.  It is made of a substance called hyaluronic acid (HA), which is the same substance that many other already approved fillers like Juvederm, Restylane, and Belotero are made of and which is found in our body's tissues naturally.  Like all things undergoing the approval process by the FDA, there is a process involved, and the reasons for a product taking time to get approved are usually based more on that process than on problems or complexity of the product itself.  The difference between Voluma and the others is that Voluma is more tightly bound between its molecules, so therefore it is firmer and provides more volume, longer lasting effects, and better contouring of deeper structures.  Because it is a HA filler, it is very safe to use on most people, and in the outside chance that an unwanted result or reaction occurs, it can usually be managed very quickly with hyaluronidase.  I have used Voluma a number of times now, and I can tell you it is a very welcome addition to our toolbox for non-surgical facial rejuvenation and volume replacement.
San Diego Plastic Surgeon
5.0 out of 5 stars 6 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.

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