New Dermal Fillers For Your Medical Spa.

The new Revanesse Versa and Teosyal RH fillers add to the growing list of available injectables.

There are a couple of new dermal fillers currently making their way into the cosmetic market in the US: Revanesse Versa, Teosyal RHA2, RHA3 and RHA4.

Revanesse has been in use since 2002 (Revanesse USA, 2018), while Teosyal has also been around for some time in Europe. They both (Revanesse Versa and Teosyal) now have FDA approval they've made their way into several clinics in the United States.

There are more than 30 dermal fillers allowed for use in the US, which makes for a crowded space. In many cases the differences between fillers in a specific product line or across competitors really boils down to user preference around viscosity, ease of use, name recognition in your patient population or any number of things. But... competition is good and just because you're comfortable using your Restylane or Juvederm line doesn't mean that you may not like something just a little better, even if it's only to allow you to reduce the price for your patients. Revanesse and Teosyal's addition to that line should give you some more tools.

Revanesse

Revanesse claims that it causes unwanted swelling less often that other HA formulations on their website.

"In a recent study another popular (HA) dermal filler was shown to produce swelling 24% more often than VersaTM. Our lower rate of swelling means many patients are able to get back to their lives almost immediately after the treatment."

In the clinical trial of Revanesse Versa 163 people participated in the study. Most injection-site adverse effects were either mild or moderate. The comparator group showed more reported filler adverse events, with an accumulated incidents of 553 events, while Revanesse had only 378.  Post-injection, 114 subjects experienced adverse effects, while 137 participants experienced effects with the comparator dermal filler. Swelling was considered a serious side effect, however, patients who have been injected with Revanesse also complained of swelling. (The feedback was from a patient review site.)

Researchers also conducted a retreatment addendum. Those who received retreatment experienced only mild to moderate adverse effects including hematoma, pain, and swelling. More patients experienced those effects seven to thirty days post injection.

Findings: Reported Frequently Injection-site TEAEs (for the first study):

• Erythema = 35/163 = 22%
• Hematoma = 82/163 = 50%
• Pain = 62/163 = 38%
• Swelling = 77/163 = 47%

Teosyal

Teosyal has a number of different fillers in its product line in the EU but it's only the RHA series that is currently approved in the US. Teoxane fillers have been examined in several studies, however there is so far one study about the RHA line showing efficacy - the filler line lasted for 6 months for the study participants (Rzany, 2018).

The Teosyal website doesn't make much in the way of claims of differentiation from other fillers but it's hard to say if it's just because they're a 'me-too' product or they don't have the data to them.

Elastagen

Aside from these two dermal fillers entering the US Market, it was announced that Allergan will acquire Elastagen’s product for $95m as part of their new injectable line, and that may change things even more. Elastagen uses Tropoelastin which has been studied in wound healing and skin repair. The potential for aesthetic use is right alongside and Allergan has probably done a lot of due diligence on Elastagen's efficacy and patient results. 

References:

https://revanesseusa.com
teoxane.com
http://revanesseversadfu.com/wp-content/uploads/2017/10/Versa-Physician-DFU.pdf
https://www.elsevier.ca/ca/product.jsp?isbn=9780323480086

Treating Possible Dermal Filler Complications

As the demand for dermal fillers rise, so are the issues that come with it. There are some that go unnoticed or untreated, which could lead to later complications.

Your medspa staff should be aware of any adverse effects that may arise during administering dermal fillers. Side effects such as redness, pain, and swelling are easily treatable and would disappear over time. What about complications? How could they be treated?

It is possible, though rare, for patients to suffer from delayed complications from dermal fillers, and staff should know how they could detect these problems early on if a patient raises concerns. Of course you're very unlikely to need to use any of these, but still, it pays to be in the know.

Possible Complications of Dermal Fillers

Most literature and American Medical Associations categorize the complications or adverse side effects of fillers depending on the on-set or delay.

Pain and infection are the most common short-term complications with dermal fillers. Many patients experience pain despite lidocaine or topic anesthetic. Bruising and swelling are also common. Nodules could appear and are a sign of an infection. A Tyndall effect also happens. Necrosis and asymmetry are also reported complications.

Vision loss is a rare complication of dermal fillers, if administered incorrectly. There have been cases of vision loss among few patients (Loh et al., 2016).

In a study by Tal and Maresky (2016), an MRI was able to detect complications in patients whom have undergone treatments.

Findings

• Fourteen subjects underwent the MRI (13 females, 1 male)
• Filler substances used:
o Polyacrylamide gel (7 patients)
o Hyaluronic acid (3 patients)
o Silicone (2)
o Collagen (2)

• Complications that arose after filler injection:
o 4 cases of abscess
o 4 of granulomata
o 3 of allergic cases

The researchers suggest that through MRI, physicians can pinpoint a procedure that could correct the previously wrong injected filler.

Treatment of Common Complications

In the event of an infection, antibiotics and steroids should be taken by the patient (if the abscess is fluctuating) or antibiotics and drainage (if the abscess is non-fluctuating) (Kim, 2014).

In the case of telangiectasia and erythema, light-based procedures can help treat this complication (Kim, 2014; Kirkpatrick and Foroglou, 2016).

Nodules can be treated with antibiotics (Liao et al., 2013); however, most researchers also characterize them as granulomas, which has different treatments depending on the onset (Kirkpatrick and Foroglou, 2016).

Steroid injection may counter the effects of certain fillers such as Radiesse, Bellafill, and Sculptra (ABCS, 2016).

Other Modes of filler removal

Experts find that not all injected dermal fillers will be removed completely. However, these dermal fillers can be removed through different means depending on the injected substance.

According to Kirkpatrick and Foroglou (2016) on the Aesthetics Journal, an invasive method is possible, with the help of an ultrasound, needles, and stab incision. Surgical options are also a possible option for migration or for untreated granuloma and biofilm (Kim, 2014). Hyaluronidase is another method of dissolving dermal fillers for certain cases and substances such as: hyaluronic acid fillers.

In the event, a patient experiences vision loss, you may check the guide provided by (Loh, 2016) in their article.

As with any other treatment, a pre-screening of the patient must be done prior to treatment to avoid complications. Prepare your worst-case scenarios if anything like this happens to any of your patients.

So would there be a need to regulate who administers these injections? As of now, several states have imposed laws that only medical staff can perform injections, while some states have enacted that only physicians are permitted to do so.

It would be best that physicians should be present during the administration of dermal fillers, if possible. So that the supervising physician can oversee how the medical staff is handling the treatment.

Injection Techniques for the Hand and Neck

In our previous post, we discussed filler injections for hand and neck rejuvenation. These procedures are on the rise, and many physicians are considering this procedure in their practice.

Injection Techniques for the Hands

There is a significant amount of literature for hand rejuvenation. Most have focused on injections and laser for the hands, as a non-surgical alternative. For this article, we shall go in detail on the injection techniques included in two studies.

LeFebvre-Vilardebo, Trevidic, and et al. (2015) go in depth with injection techniques, as different authors included in the study present their own injection methods on hands. The researchers also introduced their own injection technique: Scrape Skin Threading Technique (SSTT). Below is the table detailing more on the injection techniques.

Data from Lefebvre-Vilardebo (2015)

LeFebrve-Vilardebo and Trevidic (2015) suggest using a blunt-tip cannula when injecting. The researchers use four injection techniques to administer the CaHA.

The first method only injected without massaging, and it is most effective on a less fat hand. On the 2nd method, massaged aided in distributing the filler evenly. However, the third method showed the filler only stayed under the tendons. In using their own technique, the SSTT, it was the only technique that showed where the product was targeted.

For Dr. Moradi (2015), he used Radiesse with lidocaine HCl. In performing the procedure, he tented the skin and utilized a bolus injected in the dorsum of the hand. Specifically, Moradi injects “…proximally by the wrist-hand junction, distally the metacarpal-phalangeal joint” (p. 265s).

In addition, the doctor added smaller units for added improvement on the hands. Its intended result is to lessen the appearance of veins and tendons and improve volume.

Alternatively, in Dr. Busso’s work (2015), he used HA that would minimize the appearance of tendons. The patient should be in supine position. In order to see the veins better, Dr. Busso suggests placing the hand below the level of the heart. In addition, mark all injection sites. Then, finally, raise the hand slightly above the level of the heart.

The injection on the dorsal superficial lamina would yield easier injection administration. Injected fillers can easily spread and lessen any abnormal skin formation. Skin tenting is recommended to separate the veins from the injection area. There is a risk of nerve injury, so refrain from doing any intracompartmental injections “below the deep dorsal fascia” (p. 270S).

As for Drs. Sutton and Bucay (2015), their choice of filler is Radiesse. Like the previous cases above, cannula was used to administer the filler. The insertion of the cannula is between the 2nd and 3rd metacarpal.

The common observed side effects were edema and erythema in all cases.

Dr. Rivkin (2016) also conducted a study on hand rejuvenation and injection techniques. The author makes use of needles, instead of a cannula as mentioned in previous studies mentioned above. The technique the author adopted was injecting between the phalanges. Rivkin carefully fills in the spaces. The author expects that the appearance of vein and tendon reduce. After administering the procedure, it is recommend that the hand is massaged.

After the procedure, the author advises the patient to have hands elevated for the next couple of days and any tedious activity.

Injection Techniques for the Neck

The literature for injection techniques on the neck is limited; most studies have only studied on the use of lasers on the neck. There have been research on the neck using botulinum toxin, and there are doctors who use botox on their patients to perform a non-surgical neck lift.

Physicians should take note of the danger zones in the neck. The researchers introduced a new injection technique on the neck, which is the “Three-Dimensional Circumferential Injection Technique” (p. 1). They applied this approach on the Posterior and Lateral Subcutaneous Areas of the Neck and Anterior Subcutaneous Area of the Neck and Horizontal Neck Rings.

Below is the table that further details the study.

Data from: Calisti and Elattar (2017)

Hand and neck rejuvenation are two procedures that result in patient satisfaction. The procedures are not nascent, and it is expected to rise in the coming years.

Fillers in Men; Reshaping the Face of Masculinity

Guest Post by Dr. Ebtisam Elghblawi, an aesthetic dermatologist in Libya.

Dr. Elghblawi's interview.

Nowadays it is vital to feel confident, self assured and self content about the general look. Face and beauty is always appealing and pursuing beauty is one of the most deeply ingrained human drives as always and as ever.

It has been found that beauty is innate preference as they have noticed a three- months babies were staring for long on beautiful faces.

Over the recent years, demands for medical cosmetic procedures have growing by leaps and bounds, with an immense potential. It has been noticed that the number of patients who is receiving cosmetic has risen. Cosmetic procedures have dramatically increased in popularity over the past two decades in the USA and men newly represent a growing percentage of all consumers, beside women who still make up the main bulk of the filler market.

More than ever, males nowadays are seeking cosmetic procedures for various reasoning. They become more self-concerned and self-conscious to look their best in the impossible quest with the possible available non invasive ways.

This surge could be attributed to the pressure of the media, glamorous lifestyle magazines, and tempting television adverts and offers with movies promoting men’s trendy styles, baby “boomer” male, grooming appealing utilities, and fitness merchandise. This new trend is contributing to the rise of male aesthetic procedures in dermatology.

Men nowadays are much more open and proactive about their appearance and it’s not considered a taboo as it used to. And this can be explained to the reason of quick fix at lunch time with no downtime.

Some men will recognize particular areas of concern to combat, while others point out only the overall aging appearance.

Men generally are less price sensitive comparing to their counterpart women, and are difficult in making follow up appointment and more pain sensitive comparing to women. They want a less bruise work and pain free fix with easier administration.

Men differ from women when it comes to inject their faces, as different methods can be adopted due to the biological, anatomical and behavioural variation aspects.

Men have a squarer face, strong horizontal brow, a more angled and larger jaw, strong chin, and equally balanced upper and lower facial proportions. Thus feminizing men facial features will lead to patient’s dissatisfaction.

Any person per se is considered a piece of art, a sculpture, and herein we are creating an appealing exquisiteness. The face has divine measures. We have to look for an artist for each client faces to achieve what is desired. Also addressing patients’ main expectations and checking out realistic outcomes are the main goal in any successful aesthetic practice.

We have to hand men a large hand held mirror to appreciate and compare the treated and untreated areas.

In many instances some patients do have body ‘dysmorphia’ whereby they never appreciate nor see any positive outcomes even if it was merely subtle. It’s after all, patients own perception of their body and they could just make unnecessary troubles which we should ensure before any procedure to save the hurdles incurred after then.

The general joking says ‘the more fit men are, the worse they look, they look close to death’. As in fact heavy exercise causes fat to exhaust from a destitute area and build up in parts of the face where it conveys an ugly look for men. Many men want that quick subtle make over for their face to be probably ready for action.

In defining unique male characteristics we need to consider certain aspects in order not to feminize men. We have to emphasis on the masculine athletic look. For instance, the projected chin, chiseled jaw, and sculptured men jaw line, and the ‘alpha men’ are the preferable one. After all, men with wide angle, strong face and chin is the picture domain for most men.

There are different ways to approach men face with injectable fillers. In fact injectables are meant to shape the face subtly and not grossly without going under the knife.

Strong chin give the confidence look and adding 1-2 cm projection to the chin would imply as adding few inches to the actual height. In fact it gives the alpha men appearance. Also under eye darkness, bags, puffiness and hollowness would imply a tired look and adding little filler will give the rested and the super refreshed look and more youthful outlook.

Full face filler - subtle augmenting facial features treatment can be the right choice to approach after full face assessment. In fact small changes will give big impact and boost the self confidence and body image. Even nose hump correction, with the under eye, cheek, and chin augmentation would all reflect in one way or another with a positive attitude.

The ultimate aim is not to overuse and just aim to have a subtle favorable improved look. It’s in fact a combination between aesthetic and cosmetic reasoning to stay proactive and trendy.

It’s not favorable to augment men lips though some demand that in the western society in copying some celebrities. After all it’s everyone choice and should consider it from all aspects. However, pouty lips are considered to be sexually attractive by both men and women and certainly a feminine attribute. When augmenting lips in the male patient, under-correction is the rule to be undertaken.

Looking good is important to most people and everyone wish. Facial beauty can be defined by an amalgamation of factors that involve symmetry, visually pleasing and aesthetically pleasing geometrical proportion. After all, men are still only a small portion of most clinician’s total patient population.

The good about cosmetic injections that it offers immediate results with no downtime and thus a quick return to work after the procedure

Cosmetic dermatology continues to offer refined, improved, and new patient aesthetic treatments and desired therapies. Dermatology is a continuous, open-ended practice, and I always strive to perform the greatest procedures to my patients with the wish to enhance and improve the appearance of their skin. In many occasions, a new product and procedure doesn’t always live up to manufacturer’s promotion, expectations or advance reviews. My patient’s consulate me for advice about safety, effectiveness, and the painless performance of desired procedure, to keep them in the look they yearn for.

My greatest reward is when my patients are happy, and exceeded their expectations and improved their self esteem.

My patients in general, want to look younger, natural, refreshed, and vibrant, simply a better version of them and without any downtime.

My current driving passion is detection of skin cancer by the dermatoscope and applying my own skillful knowledge on cosmetic dermatology.

To come to an end, men who desire fillers have their own needs and anticipations. It’s important to optimize men satisfaction with the yielded outcomes. After all cosmetics are utilised to beautify, enhance attractiveness, and sometimes altering one’s look without affecting the underneath structure or functionality. And in order to optimize outcomes - cosmetic approach must be tailored for each patient individually and it’s important to have a proper understanding and a mutual communication to achieve the desired results.

Hyaluronic acids will keep on growing in both male and female patients, and the sole principles of the male face must be well-known as treatment goals in order not to feminize men. Furthermore, symmetry, steadiness, and an harmonious mix are the crucial objectives for delivering perfect treatment.

About the Author

Dr. Ebtisam Elghblawi is a Libyan-based Aesthetic Dermatologist. She is very much passionate in learning more about aesthetic medicine as she progresses in her career.

Submitting a guest post.

Soft Tissue Fillers May Be Causing Blindness in Patients?

The rising popularity of soft tissue fillers has led to a rise in reports of side effects such as blindess.

The FDA approved the use of soft tissue fillers for the correction of moderate to severe facial wrinkles and skin folds (like the nasolabial folds). Some soft tissue fillers are approved for the restoration or correction of facial fat loss in people with HIV.

But according to the Food and Drug Administration, there are risks associated with the use of these fillers.

 Any soft tissue filler can cause long-term side effects, permanent side effects, or both. However, most side effects associated with soft tissue fillers happen shortly after injection and most go away in less than two weeks.

Swelling and pain after hand treatment may last a month or more. In some cases, side effects may appear weeks, months, or years after injection.

Among the rare side effects reported to the FDA are severe allergic reactions which require immediate emergency medical assistance, migration or movement of filler material from the site of injection, leakage, or rupture of the filler material at the injection site or through the skin (which may result from tissue reaction or infection).

There were also rare reports of formation of permanent hard nodules in the face or hand, vision abnormalities, including blindness, stroke, injury to the blood supply, and damage to the skin or the lips.

Recent reports by the American Society for Dermatologic Surgery, Inc. and published by Wolters Kluwer Health, Inc. showed that with the rising popularity of soft tissue fillers has led to a rise in reports of adverse events.

The study conducted a literature review of the reported cases of blindness after the filler injection. The study also examined some prevention and management strategies that may be done.

The results were as follows:

• 98 cases of vision changes from filler were identified.
• The sites that were high risk for complications were the glabella (38.8%), nasal region (25.5%), nasolabial fold (13.3%), and forehead (12.2%).
• Autologous fat (47.9%) was the most common filler type to cause this complication, followed by hyaluronic acid (23.5%).
• The most common symptoms were immediate vision loss and pain and most of the cases of vision loss did not recover.
• Central nervous system complications were seen in 23.5% of the cases. No treatments were found to be consistently successful in treating blindness. 

Even though the risk of blindness from fillers is rare, researchers concluded that it is critical for injecting physicians to have a firm knowledge of the vascular anatomy and to understand key prevention and management strategies.

For more information: http://journals.lww.com/dermatologicsurgery/Abstract/2015/10000/Avoiding_and_Treating_Blindness_From_Fillers___A.1.aspx

Search for the Best Hyaluronic Acid Filler

The October issue of the official medical journal of the American Society of Plastic Surgeons (ASPS) reports a new and validated method for providing standard cohesivity ratings for hyaluronic acid dermal fillers.

The search for the best hyaluronic filler comes after the surge of interest in the use of dermal fillers to enhance shallow contours, soften facial creases and wrinkles and improve the appearance of recessed scars.

Dermal fillers can be very helpful in those with early signs of aging, or as a value-added part of facial rejuvenation surgery. These fillers are often injected in medspas or a surgeon's office and are predictable, with relatively minimal risks and side effects.

In 2014, ASPS data revealed that around 2.3 million dermal filler injections were done. Statistics from the Cosmetic Surgery National Data Bank and other market research show that dermal filler market in the United States is valued at a whooping $1 billion.

Hyaluronic acid dermal fillers are natural, gel-based products which are highly compatible with the body, making them the most commonly used dermal filler in the industry. Plastic surgeons are now looking for evidences that will aid them in selecting the product that will give the best result for their patients.

Though there is a wide range of available products, there still exists a lack of scientific data to support the rheologic or the flow-related properties of the available dermal fillers in the market.

Dr. Hema Sundaram, a dermatologist in Rockville, MD, Samuel Gavard Molliard, a scientist in Geneva, Switzerland, and colleagues used the ratings of cohesivity and other biophysical properties to identify the dermal filler that is suited to each procedure being done.

The biophysical characteristics of hyaluronic acid gel fillers reflect individual manufacturing processes. They confer rheologic properties that provide scientific rationale with Evidence Level II clinical correlation for selection of appropriate fillers for specific clinical applications.

Cohesivity measures the capacity of a material to "stick together" and not dissociate. It is a key property that maintains gel integrity, contributes to tissue support with natural contours, and diminishes surface irregularities.

Researchers point out that products with higher cohesivity scores are not always the best. The ranking system aims to ‘provide a scientific rationale for the intuitive selection of different products for specific clinical objectives.’

According to Dr. Sundaram and colleagues, fillers with higher cohesivity may be better used for more superficial placement, or placement in mobile areas such as around the mouth or eyes while products with lower cohesivity may be effective for use as ‘deep volumizers’.

The researchers developed a standard test for comparing the cohesivity of hyaluronic acid dermal fillers. Samples of each filler gel were dyed, then squeezed into water and stirred using automated technology.

A panel of plastic surgeon and dermatologist specialists experienced in using HA fillers then rated each sample’s cohesivity on an original five-point scale, known as the Gavard-Sundaram scale.

Cohesivity scores of the FDA-approved fillers varied across the full range of the scale: from ‘fully dispersed’ to ‘fully cohesive’. Cohesivity was rated high for one product, medium to high for three, low to medium for one, and low for one.

Aside from the data on cohesivity, researchers believe that comparative data on other rheologic properties (such as elasticity and viscosity) can make dermal filler procedures more sophisticated and successful.

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Results of the study "Cohesivity of Hyaluronic Acid Fillers: Development and Clinical Implications of a Novel Assay, Pilot Validation with a Five-Point Grading Scale, and Evaluation of Six U.S. Food and Drug Administration–Approved Fillers" may be read on: http://journals.lww.com/plasreconsurg/Fulltext/2015/10000/Cohesivity_of_Hyaluronic_Acid_Fillers__.11.aspx

Juvederm Ultra XC: Year-Long Lip Fillers

The US FDA has approved Allergan's JUVEDERM® ULTRA XC for the injection into the lips and perioral area for lip augmentation in adults over the age of 21.

Allergan's trials show that results last up to a year in the lips, but as always, there are two sides to the coin.

Since 2006, Juvederm formulations were already FDA approved for correction of moderation to severe facial wrinkles and folds such as parentheses lines around the nose and mouth. Then in 2013, the Juvederm XC for age-related mid-face volume loss was introduced.

Clinical trials for Juvederm revealed that 79% of subjects showed an improvement in lip fullness three months following the treatment. More than 78% of the subjects reported an improvement in their overall satisfaction with the smooth and natural look and feel of their lips at one year after treatment.

Executive Vice President & President, Allergan Medical Philippe Schaison said that:

As the leader in medical aesthetics, Allergan is committed to continued research and development in this area. Providing physicians and patients with premium products that allow them to achieve the aesthetic results they want is always our goal. Understanding that the desire with lip augmentation is to achieve a natural-looking and lasting result, we continued our research of JUVEDERM® ULTRA XC for the lips. With this approval, JUVEDERM®ULTRA XC is now the only filler that is approved to last up to one year in the lips while providing natural-looking results.

Juvederm Ultra XC contains a smooth gel formulation of modified form of hyaluronic acid (HA) and a small amount of lidocaine. The hyaluronic acid helps the skin to maintain its moisture and softness and the lidocaine acts as a local anesthetic to improve the comfort of the injection.

While the increase in the time between injections is going to be welcomed by patients, there are some physicians and clinics that might lose income since patients are not coming in as frequently. Additionally, these longer fillers might not be appropriate as a "first-time" filler for patients who are unsure if thy're going to love the effect. There's a big psychological difference between living with a change for a few months and an entire year. Still, the general increase in lenght is a good thing for clincs and patients who are familiar with the effects.