Is Voluma (By Juvederm) FDA Approved Yet? If Not, Why Not? What Could Be the Concerns?
Is Voluma Filler FDA Approved?
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Voluma is here!
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.
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
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Is Voluma Filler FDA Approved?
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.
Voluma to Restore Cheek Volume
Voluma FDA Approved
FDA Approved for mid facial volume loss
hyaluronic acid filler that has been approved by the FDA for mid facial volume loss (cheeks).
Juvederm Voluma is FDA approved for cheek augmentation
2. Jaw lines to smooth out jowls
3. Chin augmentation
4. Injectable rhinoplasty
5. Deep nasolabial and marionette folds
As we gain more experience with this amazing and robust product so will some of the off label indications.
As a clinical trainer for Allergan, the maker of Voluma (and Juvederm, Botox) I have found it a challenge when asked to train a novice injector in Voluma because they are not accustomed to restoring lost facial volume and injecting deeper, not just superficial lines and folds. There is no physician in the U.S. with > 7 to 8 months of clinical experience with Voluma. Your best bet is to find somebody with extensive knowledge in facial anatomy and experience with Liquid Lifts as the knowledge from the use of other fillers can be transferred to Voluma.
Ran Y. Rubinstein, MD
200 Stony Brook Court, Newburgh, New York
Board Certified Facial Plastic Surgeon
Clinical Professor New York Presbyterian Hospital
National Education Faculty (physician trainer) for:
Allergan (Juvederm, Voluma), Valient (Scultpra, Restylane),
Cynosure (Cellulaze, Precision Laser Lift) & Solta (Fraxel, Thermage)
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.