FDA – APPROVED COSMETIC DERMAL FILLERS: A REVIEW
Safety during cosmetic procedures, as well as the effectiveness of the formulas, is strictly controlled by FDA – Food and Drug Administration. They set the rules and regulations of injecting “cosmetic dermal fillers” having based their approval on supervised clinical studies.(1) We can choose from a broad variety of options without having to worry about any serious side effects or adversities – we can freely enjoy what modern cosmetic dermatology has to offer. (2) Let’s take a closer look at some of the most popular FDA – approved dermal fillers.
We can divide FDA – approved cosmetic fillers into two important categories: the fillers containing materials that are absorbed by the body over time and the fillers containing non – absorbable ingredients. (3) Currently, when it comes to the latter, FDA allows only one non – absorbable filler but we are going to come back to that later. Furthermore, some of them have adjunctive lidocaine as a safe local anesthetic to provide maximal comfort and minimal pain during the procedure.
THE ABSORBABLE DERMAL FILLERS
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Hyaluronic acid is a glycosaminoglycan (sugar) molecule which is a 100% natural component of our skin. It’s got an extremely high amount of binding sites so it can accumulate a truly immense volume of water in one place. For the same reasons, it gives the skin hydration, moisture, smoothness as well as the aforementioned volume. Its injections’ effects last mainly up to 9 – 12 months however they can last even longer than that before hyaluronic acid gets completely absorbed by the skin. (4)
- Hyaluronic acid fillers with addittion of lidocaine: Restylane Lyft with Lidocaine, RHA 2, RHA 3, RHA 4, Revanesse Versa +, Juvederm Volbella XC, Restylane Lyft with Lidocaine, Restylane Silk, Juvederm Voluma XC, Restylane Injectable Gel, Juvederm Ultra XC, Juvederm Ultra Plus XC, Prevelle Silk, Elevess
- Fillers with only hyaluronic acid: Revanesse Versa, Juvederm Vollure XC, Belotero Balance, Restylane Injectable Gel, Juvederm 24HV, Juvederm 30, Juvederm 30HV, Restylane Injectable Gel, Captique Injectable Gel
The hyaluronic acid fillers with lidocaine are injected into the deep dermis and the superficial subcutaneous tissue (the 2nd and the 3rd skin layers) usually for the correction of moderate to severe facial folds and wrinkles such as the nasolabial folds or wrinkles around the mouth (perioral rhytids). They are also used for lip and cheek augmentation as well as replenishing the volume deficit due to aging or other conditions. The youngest allowed age is 21 years old.
Simple hyaluronic acid fillers are indicated for similar purposes – the correction of moderate to severe facial wrinkles and folds, especially the nasolabial folds and lip augmentation. Being 21 is yet again a requirement however these formulas are injected into the mid to deep dermis, not embracing the subcutaneous tissue.
Collagen is another natural substance that is present in our skin, if only there. It is a building protein that gives firmness and elasticy. (5) Additionally, it stabilizes blood vessels in the skin so they aren’t as fragile and susceptible to damage. The effects of collagen fillers generally last for 3 – 4 months.
– Collagen fillers: Evolence Collagen Filler, Cosmoderm 1 Human – Based C, Fibrel, Zyplast (R), Zyderm Collagen Implant
Likewise, they are used in the correction of moderate to deep facial wrinkles and folds (the nasolabial folds in particular), nontheless they can be applied differently: in the correction of acne scars or contour deficiencies. They are injected in the superficial layer of the dermis called the papillary dermis.
Calcium hydroxylapatite is found in human teeth and bones. There, it gives them structure and density. That’s why fillers with this ingredient are often used in lipoatrophy (facial fat loss) to restore volume in the face or even in the dorsum of the hands. Moreover, they also work well in correcting moderate to severe facial wrinkles and folds, yet again with emphasis put on the nasolabial folds. The effects last for approximately 18 months.
- Calcium Hydroxylapatite fillers: Radiesse 1.3CC, Radiesse 0.3CC, Radiesse
PLLA Poly – L – Lactic Acid
This one is man – made however it is completely compatible with the human skin as well as totally biodegradable. The injections are given in a series over a period of several months so that the effects become more and more visible with time. The results last up to 2 years.
- PLLA fillers: Sculptra Aesthetic, Sculptra
Since PLLA is used as a constituent of stitches, it has to supply with cohesion, density but also be skin – friendly. Therefore it is great in facial atrophy restoration as well as in the correction of the nasolabial folds and other facial wrinkles.
THE NON – ABSORBABLE DERMAL FILLER
PMMA exists in the form of small, round particles that, as mentioned, do not get absorbed by the skin. Nevertheless, they are biocompatible. For the injections, the PMMA particles are suspended in a gel solution containing also bovine collagen so that the skin receives it better. The effects last up to 5 years, depending on the patient.
- PMMA filler: Artefill
With addition of collagen and lidocaine, its only indication is the correction of the facial wrinkles and folds around the mouth, including the well – known nasolabial folds.
ARE THESE THE ONLY INDICATIONS FOR DERMAL FILLERS?
For your own safety, yes, only the indications listed above are approved by FDA. If you have ever thought about getting an injection into the breasts, the buttocks, the feet or other parts of the body, they are forbidden since you would risk many dangerous side effects; during such a procedure you would be likely to get an infection, permanent disfigurement or scarring, embolism (the blocking of blood vessels), necrosis, stroke or even death.
SIDE EFFECTS OF DERMAL FILLERS
Every medical procedure has its smaller or bigger side effects; moreover, such misfortunes mostly do not happen, especially concerning cosmetical fillers. Nonetheless, we would have to lie to tell you that there are completely none.
The more common side effects which are likely to subside with time:
The less common side effects:
- allergic reaction
- newly – formed bumps (nodules or granulomas) which may need surgical intervention.