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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 53

Yay, Voluma is FDA approved. So what?

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 27 reviews

Is Voluma Approved by the FDA?

Yes. Voluma was approved by the FDA in the US on Oct 2013 as a deep filler to restore volume loss in the mid-face area in adults 21 years or older.

Jose Rodríguez-Feliz, MD
Miami Plastic Surgeon
5.0 out of 5 stars 5 reviews

Is Voluma Filler FDA Approved?

Thank you for your question. Voluma is FDA approved and was available for use in the US in the fall of 2013. Its main indication is for restoring lost volume in the mid-face (cheek/cheekbone) region of a patient, though physicians have been using it to augment the lost volume in other parts of the face as well, so called off-label use.  It is the same material used in Juvederm, but in a thicker gel composition, allowing it to have results for over 2 years in certain patients.

Nelson Castillo, MD
Atlanta Plastic Surgeon
5.0 out of 5 stars 7 reviews

FDA approved

As people age, the cheek area loses volume, making the cheeks flatten out and the skin droop and sag. Voluma is a hyaluronic acid filler that is approved to temporarily correct age-related volume loss in the cheek area. It instantly provides smooth, natural-looking results that last up to two years with optimal correction. Most of my patients have been very happy with their results using Voluma, even given the higher cost for this filler.  This has been approved for use in the midface by the FDA for over a year now.

Is Voluma FDA approved

Yes and it really works.
I love the dramatic results that my patients achieve, however, they look natural and refreshed, not fake and puffy.

I actually have it in my own face (because I'm old!  LOL) and like the results.

Michael A. Greenberg, MD
Elk Grove Village Dermatologist
5.0 out of 5 stars 3 reviews

Juvederm Voluma FDA approved in 2013

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 63 reviews

Voluma is FDA approved for an immediate lift

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. 


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

Is Voluma Filler FDA Approved?

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.

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.