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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? 

Doctor Answers (49)

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 18 reviews

Juvederm Voluma FDA approved in 2013

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Hola Emmanouella. Thank you for your question. Juvederm Voluma is the first and only FDA-approved dermal filler for the mid-face/cheek area. Approved in 2013, it’s quickly become a favorite in my practice for correcting and contouring the face. Juvederm Voluma has a buoyant consistency (like tofu or marshmallow) that provides natural results. Because it’s a hyaluronic acid dermal filler, it can be dissolved giving my patients ultimate choice and control with their treatment. My patients are excited that the results can last up to 2 years making it a long-lasting investment.

David Mabrie, MD
Bay Area Facial Plastic Surgeon
4.5 out of 5 stars 59 reviews

Voluma is FDA approved for an immediate lift

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Voluma was FDA approved in 2013 for injection in the mid face.  It gives an immediate lift to the skin and is fantastic for adding volume to the mid face.  The results last up to two years which is twice the amount of time as Juvederm for the same area.  Voluma is also a fantastic injection in that it molds nicely to this area and looks natural and beautiful immediately after injection.  Please consult a board certified dermatologist with experience in facial injections for the best results. 

Michele S. Green, MD
New York Dermatologist
5.0 out of 5 stars 34 reviews

Yes

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Voluma is currently FDA approved in Canada.It is designed to restore facial volume that has been lost over time.

Jerome Edelstein, MD
Toronto Plastic Surgeon
5.0 out of 5 stars 74 reviews

Is Voluma Filler FDA Approved?

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Voluma is the newest hyaluronic acid (HA) on the scene in the United States and it is FDA approved for mid-facial (cheek) volumization. It comes to us after 12 years of use in Europe and 10 years in Canada and has an excellent performance record. Like all HA fillers on the market it has a very broad safety profile with few reported complications. Furthermore, if complications occur (very rare) they can be treated quickly and effectively with reversal by an enzyme. Voluma has now become a very important tool in the armamentarium of the skilled injector. Experienced injectors choose fillers as an artist would choose a brush.
Each filler is used for different effects in different sites. Your choice of injector is probably more important than your choice of filler. Best wishes.

Kevin L. Smith, MD, FACS
Charlotte Plastic Surgeon
5.0 out of 5 stars 14 reviews

FDA approval

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Voluma has acheived FDA approval to treat mid face volume loss. It essentially provides a non surgical mid face lift. It has become one of three most often used dermal fillers.

Kris M. Reddy, MD, FACS
West Palm Beach Plastic Surgeon
4.5 out of 5 stars 18 reviews

Voluma to Restore Cheek Volume

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Voluma is actually the first and only Hyaluronic Acid filler FDA-approved for volumizing the cheek area. Hyaluronic Acid is produced naturally by the body, but that production dramatically decreases as we age, which results in a sinking and hollowing of the cheeks. Voluma can restore cheek volume for up to two years, thereby plumping the face, smoothing out lines and wrinkles, and additionally smoothing out the nasolabial folds that run from nose to mouth.

Hal Michael Bass, MD
Pembroke Pines Plastic Surgeon
4.5 out of 5 stars 31 reviews

Voluma FDA Approved

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Voluma is FDA approved to treat age related mid face volume loss.  Our office has seen beautiful, long lasting results with this filler.  Due to the unique properties of this product, it provides additional lift compared to other hyaluronic acid fillers, and it lasts up to two years!

Kent V. Hasen, MD
Naples Plastic Surgeon
5.0 out of 5 stars 32 reviews

FDA Approved for mid facial volume loss

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Yes, Voluma filler is a new
hyaluronic acid filler that has been approved by the FDA for mid facial volume loss (cheeks).

Matthew Doppelt, DO
Knoxville Dermatologist
5.0 out of 5 stars 9 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.