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

Dermal Fillers: How Often Will Patients Sue You?

Everyone is offering fillers. If you're practicing cosmetic medicine for any period of time, you're going to have an occasional unhappy patient or unwanted outcome. Since dermal fillers are so popular, we wanted to take a look at how often fillers are causing problems that result in lawsuits.

Restylane, Juvederm, HylaForm, Belotero... the fillers are all here and deeply ingrained in every practice. The safety and efficacy of fillers is pretty well known and you've probably got a lot of experience already since you're performing lip augmentation and facial wrinkle treatments every day. But it's exactly the fact that fillers are so common and performed so often that can put you at risk. The odds that any individual treatment will have an unwanted outcome is really low, but since the number of patients you're treating are quite high, it's still a possibility you need to take seriously.

Here are some interesting results from studies that have been conducted in the last few years. (Links to all of the studies are at the bottom.) 

A couple of things to note here is that sometimes we're not comparing straight apples to apples. While OB-GYNs are the most common specialty to be sued, surgeons are next. If you're a cosmetic or plastic surgeon there may be a bias that elevates your risk somewhat. (If anyone has a study showing this please link to in in the comments.)

• Medscape study, surgeons are second to OB-GYNs for being sued by the public.
• Vila-Nova da Silva et al., 2015, breast surgery was the most common procedure filed for a lawsuit.

You're undoubtedly disclosing the possible side effects and expectations when you're doing your consultations, but there's an interesting study that correlates an expectation of the clinician with an elevated risk of being sued. The study found that disclosing all possible risks and outcomes didn't scare the patients, but that those physicians who thought so were at increased risk of a suit which is interesting. (Boyll et al., 2017) 

One of the last articles JAMA Facial Plastic Surgery published in 2017 were litigation cases filed due to dermal fillers and there is some risk of unwanted outcomes or mid-term issues; Hyaluronic acid fillers typically cause swelling and infection, while CaHA causes infection and pain, and PLLA and PMMA both cause nodules. In the study, most of the swelling were found in the tear troughs, while only infection were found in the nasolabial folds. Additionally, intra-arterial injections especially without sequelae were found in the lip and nasolabial folds (Rayess et al., 2017).

Other than this study, Ezra et al. (2015) also examined litigation earlier, and may have encountered the similar cases as with Rayess et al. (2017) back then, only granulomas were found as an adverse effect that resulted in a filed suit. 

In the Ezra 2015 study,  the real cause of most of the problems becomes clear - non-physicians who are performing the injection and there can be additional disciplinary actions in addition to a patient filing suit.

From the study: (This is about disciplinary actions, not lawsuits)

A total of 24 legal documents were identified: 19 cases and 5 disciplinary actions. Of the 19 cases, physicians were named as defendants in 13. Six of the 7 cases that named a nonphysician as a defendant involved a substance being injected different than the reported filler. Overall, 50% of legal actions from soft-tissue fillers were related to a nonphysician performing the procedure. Of physician subspecialists, dermatologists and plastic surgeons had the highest proportion of litigation (17% each); this is likely due to these specialties performing a higher volume of the relevant procedures. The majority of disciplinary actions were reprimanding physicians for not being present while a nonphysician employee injected patients with soft-tissue fillers. In 3 of the 5 reprimands, physicians were functioning as medical directors of medical spas.

The chances that you'll be sued by a patient for a filler injection treatment is extremely small unless you're doing something stupid like allowing someone who is unqualified, unskilled, or unlicensed. Be sure that you're using clinic best practices and procedures and that your staff is trained. Almost all of these problems can be avoided if you avoid the trap of thinking that any procedure is routine.

References:

• https://jamanetwork.com/journals/jamafacialplasticsurgery/article-abstract/2665429?redirect=true
• http://www.jaad.org/article/S0190-9622(15)01857-5/fulltext
• https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjx182/4461847?redirectedFrom=fulltext

Non-Surgical Nipple Reconstruction or Correction Using Dermal Fillers

Using filler injections to treat the areola nipple complex (NAC) after surgery.

Most hyaluronic acid filler studies focused on dermal fillers are about injection techniques and areas of injection in the face, and sometimes the hands, but hyaluronic acid fillers’ other function can also be used in reconstruction. There are only a few cases in using dermal fillers to correct or reconstruct any physical surgical complications.

One case of using dermal fillers was to reconstruct the nipple areola complex, which for some patients, they lose the Nipple Areola Complex (NAC) projection after surgery (Belman et al., 2017).  The article’s case focused on a 49-year-old woman who has undergone a mastectomy, and the researchers observe that sometimes after surgery the NAC suffers from atrophy. As such, the physicians of the study sought to correct the surgery using dermal fillers. A bilateral injection was made on each nipple, and the procedure was a success adding projection after injection.

Key Findings:

• Increase of 1.5-1.6mm on both breasts
• Nipple projection for both breasts are 3.3mm after injection

A similar study was conducted back in 2010 where the researchers used Artecoll to augment the nipple (McCarthy, 2010). It also focused on creating better nipple projection. Twenty-three patients underwent the procedure in the study, and with the use of Artecoll, the mean post-injection was higher than pre-injection.

There was a case wherein a patient had multiple cleft lip and palate surgeries (Stolic et al., 2015). The injection was carried out after biphasic therapy. The researchers mentioned the importance of injection technique when correcting the surgical complications.

Another case involved injectables to reconstruct soft tissue on the ear. In that case, the study’s investigators used Macrolane. The study’s investigators conducted multiple injection sessions to expand the ear needing reconstruction and expansion. There were no reported complications after the treatment sessions.

Despite the studies’ outcomes, adverse effects may arise with the patient, and it could be necessary to follow-up with the patient after a few weeks or months. Bottomline is, dermal fillers help patients give a natural look, if the physician knows what they’re doing. It is important to know injection techniques as well to avoid any complications.

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.

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