Lip augmentation is one of the most common and historic procedures for hyaluronic acid-based injectable fillers. It would surprise many then to find out that despite its popularity and common usage, few of these injectable fillers are actually FDA-approved for use in the lips. There are a variety of reasons for this lack of approval but safety and effectiveness are not among them.
On October 1, 2015 the US FDA has approved Juvederm Ultra XC for injection into the lips and perioral (mouth) area for aesthetic augmentation in adults. Juvederm Ultra XC and Juvederm Ultra Plus XC injectable fillers are already FDA-approved for injection for moderate to severe facial wrinkles and folds around the nose and mouth. (nasolabial folds) Juvederm Ultra XC is a well known modified form of hyaluronic acid with prolonged duration (up to a year) that has lidocaine in it to improve the comfort of the treatment.
In FDA trials of Juvederm Ultra XC for lip augmentation, almost 80% of patients had visible improvement in lip fullness three months after injection. A near similar percent, (78%) stated that they had persistent improvement in lip size one year after injection. The most common adverse effects for Juvederm Ultra XC injectable filler are the same as other hyaluronic acid gels such as temporary swelling, redness and lumps and bumps.
What is unique about Juvederm Ultra XC injectable filler is that it offers long-term retention of lip augmentation results. Many hyaluronic acid-based injectable fillers are used for lip augmentation but their results often last six months or less.
One important aspect of hand rejuvenation is volume restoration of the back (dorsum) of the hand. Skeletonization of the hand occurs through loss of subcutaneous fat allowing the tendons and bones to be easily seen which is associated with aging. (bony hands) This has been shown to be effectively treated using a variety of filler materials. The most commonly used are many of the off-the-shelf synthetic fillers since they can be done in the office under local anesthesia for a quick plumping of the back of the hands.
One of the potential synthetic injectabl efillers to use in the hand is Radiesse. This is an opaque injectable filler that contains calcium hydroxyapatite microspheres in a water-based gel carrier. It has been used for facial augmentation since it was introduced in 2001 and has a longevity of around one year after injection.
The US Food and Drug Administration (FDA) just announced that they have approved Radiesse for hand augmentation to correct volume loss in the dorsum of the hands. FDA approval essentially means that it is both safe and effective for this use and that its benefits outweigh the potential risks. The clinical study data to support its use was done in the hands of over 100 middle-aged women using grading scales of aesthetic improvement. Compared to a placebo (control) filler, Radiesse treated hands had at least a one-point improvement at three months after treatment compared to just 3% for the controls and 98% of the patient reported visible improvement by their assessment. Any adverse effects that occurred from the treatments were common to what is known for any injectable filler such as temporary redness, swelling and bruising which all resolved within one week after injection.
Radiesse provides an effective method of hand rejuvenation that has some of teh better persistence of any filler on the market today. Despite its white opaque color it is not seen through the skin as such and is not visible through the skin.
The lips are one of the most unique areas of the face to be treated by injectable fillers. The lips are extremely soft and supple, have a high number of nerve endings and are the most frequently touched part of the entire face. They also have a somewhat complex shape to them and undergo a lot of different types of muscular movements. Therefore, injectable filler techniques are the most challenging to perform in the lips to get good results as well as to limit any potential complications.
While there are a large number of injectable filler types available today, when it comes to the lips, hyaluronic acid-based types have the highest safety profile. Semi-permanent fillers such as Radiesse, Artefill and Sculptra should be avoided since the muscular movement of the lips can cause clumping and potential nodule formation. But because of the water-absorbing properties of hyaluronic acid fillers, undercorrection at the time of treatment is preferred to avoid prolonged swelling or ultimate overcorrection.
Injections of the lips should be principally done by small gauge microcannulas. They limit the amount of swelling and bruising because they do not cut through the sensitive lip tissues with their blunt tips. They are also more flexible than rigid needles. Through entrance sites in the corners of the mouth, microcannulas can be used to contour and lift lips that would otherwise need multiple puncture sites by a needle. The lack of tissue trauma by the blunt nature of the microcannula makes treatments bloodless and much more comfortable than needles.
The only thing a microcannula can not do is touch-up or fine tune small areas of the lips. This is where the use of a small 30 gauge needle can be beneficial to get to where a microcannula can not. But with today’s fillers that contain lidocaine, the use of a needle to touch up lip areas can be done painlessly since they will usually be numb from the initial layer of filler laid down by the microcannula injection.
Microcannulas for injectable fillers are available in different small diameters (down to as small as 30 gauge) and in different lengths. But the lips are best treated by using long 1’ 1/2” lengths of 27 gauge diameters. They can reach to the cupid’s bow on each side of the lip and can out a layer of material back down to the corners in one smooth pass.
Acne scarring remains a very difficult facial problem that defies any single method of improvement. Fundamentally, acne scars are treated by either outer skin resurfacing, complete excision, or injectable filling for pushing out the depressed scar. Each approach has its own utility based on the type of acne scar size and shape.
The simplest and easiest treatment to apply for acne scars are injectable fillers. And for the right type of acne scar (broader based saucer shape scars or atrophic acne scars), the push of a filler can be very effective. But not all fillers push out scars equally and all have variable time periods of persistence.
In the July 2014 issue of the American Academy of Dermatology, a study was published entitled ‘A Double-Blind, Randomized, Multicenter, Controlled Trial Of Suspended Polymethylmethacrylate Microspheres For The Correction Of Atrophic Facial Acne Scars’. In this study, nearly 150 patients that had multiple rolling, atrophic acne scars randomly received PMMA-collagen (Artefill) or saline injections.. They usually received two injections session and were followed for up to six months after treatment. Success was obtained in two-thirds (64%) of the Artefill injected patients compared to one-third of those that had received saline injections.. Adverse reactions to Artefill were mild and reversible. No differences were seen between ages, race or skin types.
It is not surprising that a particulated filler would produce better results in depressed scars than water (saline) or even a non-particulated filler. (not studied) The viscosity and push of an injectable filler like Artefill is simply more robust which is exactly what scarred and atrophic skin needs to be sufficiently elevated. The observation that almost all acne scars were not improved by Artefill is somewhat surprising but that is probably reflective of the tough adherence of many acne scars and injector technique. What is not shown in the study is how long the Artefill effect lasts but this was really a pilot study to evaluate safety and effectiveness.
One very interesting aspect of this study was that saline injections produced any effectiveness at all, not that Artefill was more effective. This effect is hard to explain particularly at the six month follow-up period. Does saline alone by lifting the scar produce some degree of collagen formation?
Loss of facial fat is a common occurrence as many people age. With loss of this fat volume comes tissue sagging, some of which would not have occurred if it was held up better by retained tissue support. One of today’s new uses for injectable fillers is in the treatment of this facial pseudoptosis. Using injectable materials to replace lost fat volume and restore contours to a variety of bony and soft tissue facial contours is now best known as filler rejuvenation.
Much of filler rejuvenation is focused on the temples, orbital hollowing and the submalar region, classic facial areas affected by fat volume loss/atrophy. Injecting into these areas can help plump back fat lost and soften a face that may have become gaunt and hard due to a skeletonization effect. While the volume of filler needed can often be substantial, 2ccs or more, the facial rejuvenation effect can be quite significant.
Choosing the right injectable filler, however, is critical as not all fillers create the same effect at the same injected volume. In addition, each filler has a different duration of effect. What one would use for superficial lines and wrinkles is different than what should be used for facial folds. The amount of ‘push’ of the filler needed is quite different. But what works for facial folds is similar to the type of fillers needed to create a facial volumization effect.
The four injectable fillers today that are most appropriate for filler rejuvenation are Juvederm Voluma, Radiesse, Sculptra and Perlane. The latter three are well known, having been around for awhile. Juvederm Voluma is the newest filler and is the only hyaluronic acid-based filler that is FDA-approved for cheek augmentation, a specific facial volume effect. What creates the lifting effect of Juvederm Voluma is the cross-linking of the hyaluron molecules so they have more viscosity. This greater stiffness allows for a better push on the surrounding and overlying soft tissues.
While there are proponents for each of these voluminizing fillers, they have various advantages and disadvantages. Voluma, Radiesse and Perlane work very similarly and are injected through slightly larger needles than their thinner more superficial wrinkle counterparts. What separates Sculptra from the others is that it is better suited for an overall treatment of a thinning face even beyond the fat pads into all subcutaneous facial planes. Its more liquid composition allows for larger volumes of material to be delivered.
Filler rejuvenation provides a variety of temporary but helpful effects. They can pick up a sagging midface to lighten a heavier lower face. This allows the focus to be redirected back to the eyes. Restoring lost temple volume makes one look healthier and helps balance out the face.
If one likes these filler rejuvenation effects, injection treatments can be repeated or the consideration given to fat injections for a hopefully a greater long-term effect.
The search for a less invasive way to change the shape of one’s nose has only more recently been possible through the use of injectable fillers. Their use in the nose has been labeled as an injectable rhinoplasty or a non-surgical rhinoplasty. Using injectable fillers for certain nasal shape problems or to correct secondary rhinoplasty deformities has its merits. It is quick to do, has a low cost and avoids any type of recovery associated with a more invasive rhinoplasty.
An injectable rhinoplasty can be very successfully done but the question is what filler material is best to do it. With over a dozen filler materials currently available, the most commonly used have been silicone, numerous hyaluronic acid (HA) formulations and calcium hydroxyapatite gel. (CaHA) While all of these have successful histories of general facial soft tissue augmentation, their use in the nose should be approached with a heightened sense of caution.
Silicone (Silikon 1000) is the least commonly used injectable filler and is not FDA-approved for any soft tissue augmentation procedure. But there are more than a handful of practitioners who use it for those patients who seek permanent injectable filler results. While there is no question that silicone injections can work, they are also known to cause significant granulomatous reactions which can be difficult to treat and impossible to ever completely remove the material from the tissues. While silicone filler advocates point to injector technique as the cause of any problems with its use, it is best avoided in the nose.
Calcium hydroxyapatite gel (CaHA, Radiesse) is a thicker more viscous material due to its microspherical content. It is not associated with any significant granulomatous reactions and can safely be put into the nose. But it requires a bigger needle to insert and this can be more uncomfortable to the patient. (not that any nasal injection is pain-free) But its long-lasting effects may justify that trade-off if one has a compassionate injector.
Any of the hyaluronic-acid (HA) fillers offer the easiest and smoothest injection into the thinner tissues of the nose due their smooth linear flow capabililties. Even long lasting HA fillers inject fairly easily. They probably offer the least risk of adverse tissue reactions due to their hyaluron composition and push on the tissues, but this is certainly volume dependent. Many of the HA fillers today have the local anesthetic lidocaine in them, which will not really helping with reducing injection discomfort on the first pass, can make subsequent injections more comfortable and will eliminate any early postinjection discomfort.
While different injectable fillers can be used safely in the nose, how and where they are placed is critical to minimize complications. The injection should be placed deep (sub-SMAS) to eliminate visible lumping of the material. The safest nose areas to inject are the dorsum/radix and bony side walls where the tissues are more elastic and have a resplendid blood supply. Larger volumes of fillers can be easily placed here. While injections can be done in the tip and nostril area, this is where the most complications are seen including tissue necrosis. Very judicious small amount of fillers should be used in these areas if one must do so.
While the injectable and non-surgical rhinoplasty is ‘easy’ to do and offers a quick fix for select nasal problems, it is not complication-free. (nor is it permanent) Caution should be used when injecting into the nose including the choice of filler and the injection location. Injectable fillers work well for camouflaging small to moderate dorsal humps, to correct nasal bones that have been collapsed or have asymmetry and ‘top off’ a rhinoplasty where there remains a slight residual hump.
With over a dozen injectable fillers on the aesthetic facial market in the U.S, and new ones appearing annually, a news release that another injectable filler product or indication has been approved is not revolutionary. Such is the case today as the Food and Drug Administration has given clearance for Restylane Silk injectable filler manufactured by Valeant pharmaceutical company. Restylane Silk is an injectable hyaluronic acid-based filler that contains 0.3% lidocaine. The uniqueness of this injectable filler product is that it is approved for lip augmentation and the treatment of perioral rhytids (mouth wrinkles) in patients 21 years or older.
In a clinical study that led to its approval, Restylane Silk was studied in over 220 patients for its effectiveness and safety for lip augmentation and direct injection into the dermis of mouth wrinkles. The study results showed that almost 100% had improvement in lip fullness two weeks after the treatments and over 75% had sustained lip fullness improvement six months later. Adverse events reported were very typical including temporary swelling and bruising and pain on injection.
Lip augmentation by injectable fillers has been around long before even the first FDA-approved product (the original Restylane) was initially approved in 2002. They have been used ‘off-label’ for lip and perioral treatments for over twenty years. They have been and will continue to be in high demand for lip enhancement due to their immediate effects and usually good results. (which are highly injector dependent) The major players in the injectable filler market have been slowly getting around to get formal FDA approval for lips and Restylane Silk now fulfills that objective for the Valeant product line. It is now the second injectable filler after Juvederm to get formally approved for lip augmentation.
The key to a good injectable filler for the lips are that it should be hyaluron-based (for assured and uncomplicated resorption), have a viscosity that permits an easy flow through a 30 gauge needle (to lessen the occurrence of lumps and clumps) and it has a lidocaine additive. (to lessen immediate after injection discomfort)
Background: Injectable fillers along with Botox has revolutionized facial rejuvenation. While often confused from the public’s perspective, injectable fillers are used for soft tissue enhancement such as softening nasolabial folds and enlarging lips. But as the number and types of injectable fillers has grown over the past decade, their uses has been expanded to include more facial volumizing effects. One of these facial volume effects has been to create skeletal highlights of the bony prominences such as the cheeks, chin, jaw angles and brow ridges.
While no injectable filler can create a permanent facial skeletal enhancement effect, there are some benefits to a temporary one. For those who are interested in having a permanent facial implant but are uncertain that they might like the result, an injectable filler can be a good reversible test. If one does not like the result, the filler will eventually go away…all without ever having to undergo invasive surgery. Conversely, if one likes the effect repeat treatments can be done or one can convert to an actual facial implant.
While any injectable filler can be used for facial skeletal enhancement, many are not appropriate to be so used. To create a facial skeletal enhancement effect the filler must be capable of providing a good soft tissue push as it is injected along the surface of the bone. The ability of any filler to create this push has been traditionally thought of being due to its G prime factor and its cohesiveness. From a rheologic standpoint this makes sense but has never been proven to be true. A recent study has demonstrated that a good lifting effect of a filler is due more to how its hyaluronic acid chains are manufactured and put together than just its G prime factor alone.
Some good injectable fillers for facial skeletal enhancement that provide a good soft tissue push are the newer Juvederm Voluma, Radiesse, and Perlane. All of these are also associated with a longer last effect due to their slower resorption times. Juvederm Voluma has been recently FDA-approved for midface/cheek augmentation but its good soft tissue lifting capabilities indicates that it would be good for other facial skeletal areas as well.
Case Study: This 31 year-old female has been having Radiesse injections into her chin for several years for a chin augmentation effect. They always lasted less than one year. The search for along-lasting effect led to try Juvederm Voluma.
As an office procedures, Juvederm Voluma was injected with a 27 gauge needle into the point of her chin in three different locations injecting from the bone outward. The goal was to create a more triangular-shaped chin with a slight increase in horizontal projection. A total of 1cc or one syringe of Juvederm Voluma was used.
The use of injectable fillers for chin augmentation can be effective for small reshaping effects. Slight amounts of increased horizontal projection and chin narrowing or widening can be achieved by injection location. One or two ccs (syringes) of a longer-lasting filler should be able to create a chin augmentation that lasts up to one year after injection.
1) Injectable fillers can be used for facia skeletal augmentation of the cheeks, chin and jaw angles.
2) The type of injectable filler that works best for facial skeletal augmentation must generate a good soft tissue push based on his G prime factor, cohesiveness and how it is manufactured.
3) Juvederm Voluma injectable filler is approved for cheek/midface augmentation but can be used for chin enhancement as well either as a trial implant test or for a temporary augmentation effect.
Background: The ear is essentially fully grown by around age none and is close to 60mms in vertical length. (slight less in women and slightly more in men) Unlike the rest of the ear above it, the earlobe has no cartilage and is composed of flexible skin and fat. The size of the earlobe is usually around 20mms or about 1/3 of the total vertical length of the ear.
There are many variations in the size and shape of the earlobes. Earlobes are often perceived as being either free or attached, but earlobes can also vary greatly in size. Some people are born with very small earlobes that have a scant lobule appearance. Their vertical height is significantly under the 1/3 relationship to the rest of the ear and may be as small as just 1 cm or less.
Earlobe augmentation or vertical lengthening is an infrequently requested aesthetic procedure. Making the earlobes longer is possible because they are not constrained by rigid cartilage inside its skin. Methods to enlarge them include injectable fillers, fat injections, dermal-fat grafts and cartilage graft inserts. A good first treatment is to place temporary injectable filler to see if one likes the effect created.
Case Study: This 22 year-old male wanted to have more prominent earlobes. He felt they were too small for the size of his ear. It was discussed with him that injectable fillers should be initially placed as a reversible treatment method and see if he liked the change created.
Under a local anesthetic earlobe block, each earlobe was injected with .4ccs of Juvederm filler. Filler was added in increments with the patient checking in s mirror so the earlobes did get overfilled.
If he decides to opt for permanent earlobe lengthening later, his option include fat injections or placing a small dermal fat graft from a small incision on the back of the earlobe.
1) Injectable fillers have a wide variety of uses for soft tissue augmentation, including the earlobes.
2) Earlobe rejuvenation and lengthening can be done by injectable filler to help correct an atrophic earlobe or to lengthen a short one.
3) Injectable fillers for earlobe lengthening can be an initial test to see if the changes are acceptable before proceeding to more permanent and invasive procedures.
Injectable fillers, along with Botox, have revolutionized the treatment of the aging face particularly one early in the process. The number of such injectable facial treatments around the world must surely number in the billions at this point in time over the past twenty years. The typical complications from injections are largely aesthetic and are well known. There are few major complications that have been reported, of which skin loss or necrosis is the most dire consequence.
Irreversible vision loss can now be included in the list of major complications from injectable facial fillers. In the March 2014 issue for JAMA Ophthalmology, an article appeared entitled ‘Cosmetic Facial Fillers and Severe Vision Loss’. In this paper, three patients were reported that had central retinal artery occlusion right after receiving injections of different injectable facial fillers in the forehead area. All three patients had injections of either a hyaluronic acid filler, fat and Artefill in the high forehead area. Adverse changes to the retinal circulation were demonstrated by fluorescein angiography. All three patients had persistent visual field defects that did not resolve.
While there have been previous reports of eye complications from injections of other facial areas, this is the first report of it happening from injections into the forehead. While extremely rare, the highly vascularized tissues of the entire periorbital area make it an ever present albeit remote possibility.
The cause of injectable filler vision loss is retrograde flow. Since all fillers are injected through the smallest needle as possible, they are done so under higher pressure. The more viscous the filler material, the higher pressure that it comes out of the needle. According to the authors of this paper, when an injection is made under a higher force the injected substance gets into the external carotid vessel at a high enough force that it flows backward into the internal carotid and into the eye. This results in occlusion of the central or branch retinal artery or the posterior ciliary circulation, both of which branch from the ophthalmic artery. All three reported patients demonstrated choroidal filling defects and retinal arterial involvement.
According to the American Society of Plastic Surgeon’s statistics for 2013, well over two million injectable filler treatments were performed…and this number does not include every other type of doctor who may perform them. Even if these were the only cases of visual problems that have occurred in a single year, this places the risk at 1 in a million or more treatments. While rare, it can still happen and the best way to avoid it is to use microcannulas for injections and not needles. This makes it much harder to inadvertently enter the vessels around the eye.
Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.