Medical Spa MD: Physician community of skin clinics, laser centers, plastic surgeons, dermatologists and aesthetic doctors practicing nonsurgical cosmetic medicine.
A recent study shows that immediate post-surgery Botox injection could create a better scar appearance as opposed to delaying the Botox injection days after (Hu et al., 2018). The participating authors used saline to treat the other side of the scar side of the scar. Nineteen scars were evaluated in the study, and the authors used the Vancouver scar scale and the visual analogue scale.
Read MoreNeuromodulators or botulinum toxins continue to gain popularity considering its effects on patients. Botox remains one of the most trusted brands in the market, and it does not seem to slow down along with the other two brands, Xeomin and Dysport. Of course, not everyone approves of having the botulinum toxins injected on them because of the effects that it has brought.
Revance Aesthetics is currently testing its RT002, and has had studies published regarding the efficacy of their neuromodulator, meanwhile EB-001 is fairly new but according to the company, their botulinum toxin seems to take effect much quicker than the current ones in the market. In that light, will the big neuromodulators brands be replaced by those still in testing phase?
In a previous article we published, we also wrote about Nabota, which has already been in use by some countries. Revance’s RT002 and Bonti’s EB-001 are currently undergoing trials, but both show potential.
According to Bonti, around 32% of patients show interest in having EB-001 injected on them. In a press release, the company mentioned they have conducted a clinical study, and it supports their claims about the product’s safety and efficacy. The product aims to be an introductory neuromodulator for those who have not tried and for time sensitive events.
As of December 2017, RT002 has reached Phase 3, which is showing better results than Botox. According to press releases, RT002 will have a six month duration period. If approved by the FDA, it’s the only neuromodulator that could ever receive that approval. Like the other neuromodulators, it has adverse effects like ptosis and headaches. Phase 3 will end its testing by February 2018.
These new brands will definitely shake the aesthetic market, since providers will have different options to choose. However, would these brands be able to replace the current ones?
These products will continue to compete regarding which one botulinum toxin would be enough to treat glabellar lines and crow’s feet, it is still unknown which among these treat these concern areas better. It is highly unlikely that the current three neuromodulators will be replaced, but possibly their market might change as there are other patients. Currently, patients can enjoy the present neuromodulators provided in your medical spa or practice.
There's a reasons that all of these companies are launching botox competitors... As a collective, Botox is the biggest money-maker in the injection market by a long ways.
Here comes another one: Revanace, who promises longer duration than Botox. You can take a look a the company website here
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced the completion of its Type B / pre-IND / pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) regarding DaxibotulinumtoxinA for Injection (RT002) for the treatment of glabellar (frown) lines.
In this trial there were five different groups for testing for 268 subjects. There were subjects for 20U, 40U, and 60U of daxibotulinumtoxinA, participants for 20U, and some more subjects for placebo.
In Week 4, daxibotulinumtoxinA was still at 100% efficacy rate among the participants. The determinant was the Investigator Global Assessment - Facial Wrinkle Severity (IGA-FWS) scoring, in which most participants from all groups gave a 1-point improvement. In the end, the daxibotulinumtoxinA shows greater efficacy with 40U as compared to onabotulinumtoxin 20U treatment 8 to 20 weeks post-injection, even attaining 2 more points on the scale. It was well tolerated and showed longer duration.
daxibotulinumtoxinA seems to show more its efficacy and shows potential a competitor of the big three botulinum toxins. Revance might give the current competitors a run for their money, however Botox Cosmetic, Dysport, and Xeomin are trusted brands. Revance’s product is at Phase 3 trials and the trial is estimated to finish December 2018.
There's another competitor in the same state: Daewoong’s NABOTA currently undergoing clinical trials to receive FDA Approval. The daxibotulinumtoxinA aims to treat such as wrinkles, cervical dystonia, and plantar fasciitis. Clinical trials for the latter two treatment areas are also undergoing.
Guess what? That Botox that you're injecting may be having an effect on more than just crows-feet.
File this under "cool things you can bring up during a Botox consultation".
In a study (Finzi et al., 2014), researchers found that it can also help treat symptoms of depression.
According to the P.I., Professor Norman Rosenthal the research offers a new approach that shouldn't conflict with other treatments the patient might be on.
The reserarchers injected 74 subjects, half with Botox and half with a placebo.
From the abstract:
To determine the antidepressant effect of onabotulinumtoxinA (OBA) treatment of corrugator and procerus muscles in people with major depressive disorder, we conducted a double blind, randomized, placebo-controlled trial. In an outpatient clinical research center, eighty-five subjects with DSM-IV major depression were randomized to receive either OBA (29 units for females and 40 units for males) or saline injections into corrugator and procerus frown muscles (74 subjects were entered into the analysis). Subjects were rated at screening, and 3 and 6 weeks after OBA treatment. The primary outcome measure was the response rate, as defined by ≥ 50% decrease in score on the Montgomery–Asberg Depression Rating Scale (MADRS).
The result showed that in the group that got the Botox injections there was a 47% reduction in depression symptoms. The p;acebo group showed a reduction of just 21%.
The thinking is that there's a feedback loop where facial espressions aren't just an expression, but can actually influence mood. So people who can't frown (for whatever reason) aren't getting that reinforcement and feel less depressed. It's a theory from a new area of psychology called embodied cognition - the idea that we actually think with our bodies. So the Botox makes it harder to frown = people feel less depressed.
If the FDA clears Nabota, a neuromodulator making its way to the US Market, it could become yet another Botox alternative fighting for market share?The South Korean pharmaceutical company Daewoong is gearing up to become the newest manufacturer of a Botox alternative in the US market. Nabota, a botulinum toxin type A injectable neurotoxin, is cleared by several Asian and South American countries to use. For its market entry to the US, clinical trials are in process which could lead to an FDA approval.
Clinical trials
Currently there are two trials for NABOTA. One is for blepharospasm, and another for Crow’s feet. Literature comparing the efficacy of Botox, Dysport, and Xeomin are limited for Crow’s feet. Despite such, there have been studies about how effective these three neuromodulators are and were found effective by several researchers.
Implications
More botulinum toxin products mean more competition. Plastic surgery is common in South Korea, and beauty standards are high. Nabota could give Botox, Dysport, and Xeomin a run for their money if Nabota can deliver longer and better outcomes.
There are limited literature on the efficacy of Nabota. In one study comparing Botox, Daewoong's drug proved more effective. Other studies focused on NABOTA were for post-stroke upper limb spasticity (Nam et al., 2015), masseter reduction (Wanitphakdeedecha, 2016), and masseter muscle hypertrophy (No, 2015).
Its possible implication, once it is FDA approved, is the idea of using Nabota’s efficacy, which Botox and the others are unable to treat in the long term.
Differences with the Current Three
According to Dressler (2016), Nabota has a special purification process. No other information about the process has been disclosed. In a book by Seo (2017), the author tabulated a comparison of all the current botulinum toxin products. There are little to no significant differences with the current US neuromodulators.
So this raises the question of, would practices carry Nabota or would they stick with Botox and the others?
You've got to have them since they're one of the primary reasons you're generating new patients AND they keep those patients coming back every month or two. Many generalized (includes surgical treatments) generate 40% of their income from injectables and others (nonsurgical) can turn these needles into wildly profitable practices. But you can also spin your wheels just bumping along the barely-breaking-even line by either under-pricing or over-paying. So what's the current state of cost/price in the market?
In a market report released in 2015, according to Research and Markets, dermal fillers average price (in the US at least) are estimated around $400-$1500 per treatment (patient cost). That's quite a range. So what's going on here? It's a busy and (increasingly) confusing market but here are some stats/thoughts on some of the market leaders.
Radiesse is primarily around the patient's mouth (specifically correcting nasolabial folds but also lips) but is also commonly used to increase volume in hands (where you can end up using a lot of it, increasing the cost/price). Typical usage is between a half to 2 or more syringes. Like with other facial fillers, the effects on Radiesse on the body will take for as long as 10-12 months. An average cost for a Radiesse treatment is around $900, with a range of $400-$1200. Most procedures are on the chin and cheeks.
Patient satisfaction seems to be around 83%. Adverse reactions include ashes, loss of volume swelling, and lumping. These, as with others, are generally attributable to poor technique or over-treatment.
Similar to Radiesse, Belotero targets the nasolabial folds and the lines around the mouth. Although, there are some physicians that have used it to target dark circles and lines under the eyes.
It is possible to get multiple treatments for Belotero as well. The filler lasts around to 6 months, maybe up to a year. Although some patients may have shorter filler effects. The treatment costs around $625.00, with a range of $200-$1350.
Patient reviews (from a well known patient site) tended to be slightly higher than Radiesse which is interesting but not terribly informative. It worked well for patients who had their under eye lines treated, on their lip lines, crows' feet, tear troughs, and glabellar area. Complaints include bruising, swelling, and bumpiness.
Sculptra is a liquid based injectable that also targets the above mentioned treatments for lines. The use for the filler has been used for those who have lost weight and want to treat lines.
Primary treatment areas for Sculptra are temples and jowls and there's some increase in the after-care instructions including daily 'face massage' of the treatment areas. Repeat treatments may need to be administered after four to six or four to eight weeks, depending on the patient's results from the first treatment. (Always better to under-treat and have them come back than over-treat and have them unhappy.)
Price of treatment is around $1900, with a range of $150-$3800. Selling price of Sculptra to physicians is estimated around $750-$800. According to some physicians Sculptra retains on the face for around 6 to 24 months.
Sculptra seems to hover around a 90% patient satisfaction rate. Among the reviews on one website, 21% reported lumping and adverse reactions (which seems high).
Juvederm is one of the most popular volume enhancing fillers in the market. The target areas are lips, cheeks, and lines and wrinkles. A technique to administering the filler on the cheek is creating circles around the target area (similar to a Venn Diagram). Aside from the cheeks, lips are also a popular treatment region.
Juvederm products have a selling price of around $350-$1000. Cost of treatment is around $550, ranging from $250-$990. Treatment lasts from 6 to 12 months.
In looking into patient feedback, only Juvederm received more than 90% positive rate from patients across different review websites. Many are also doing returning treatments after their results. Common complaints for the filler are sagging and swelling under eyes and lips.
We thought we'd take a look at something outside of fillers with Kybella since it's main usage is to remove the fat under the chin. Multiple treatments are done to achieve the expected result. Like with all the treatments here, Kybella can be done quickly. In administering Kybella, the box comes with a temporary tattoo guide which should be stuck under the chin. (We don't have personal experience with this so would appreciate ayone's thoughts from the community.)
Physicians buy a vial of Kybella at around $600. As for prices, Kybella has a range of $600-$2500 for a treatment, with an average of $1375.
The treatment is well received with an 87% positive rating on one website. Swelling is normal with the treatment after a few days. The treatment had boosted patient self-esteem. Negative reviews are few so far, some had mentioned they saw no change prior to treatment and should have opted Liposuction over injections.
Read the sister post on pricing of Botox, Xeomin & Dysport.
There are a lot of physicians who enter the market at the low end of pricing in order to attract new patients (very successfully since this is essentially a commodity now) but if your prices don't include enough just to break-even, you’re heading for trouble. Medical businesses are expensive to run and it's more true than ever that a dollar saved is a dollar earned. All vendors are not all pricing fillers the same and it can cost you literally thousands of dollars a month right off the top-line profit if you're not getting the best deal from your local pharmacy or the manufacturer. Depending upon where you are in the world you might want to do a little research and find out if you can get a better deal.
Warning: Everyone is getting bombarded with solicitations from companies in China promising the lowest cost. Do NOT buy any drugs or pharmacy products from China (or South East Asia, or Africa). These countries do not have the same regulations as the US, Canada, and the EU where regulatory safeguards are in place.
With Botox, Dysport and now Xeomin targeting wrinkles, and Juvederm, Radiesse, Kybella, Scupltra, and Belotero for volume/fullness, injection based treatments are the initial treatment point of contact for most cosmetic clinics, even those run by surgeons.
With the prevalence of these treatments we thought we'd take a look at the current state of care in the US (the largest single market) since there are a number of new players that are making inroads and taking some market share from the biggest players.
First up; Botox, Dysport and Xeomin.
Botox, Dysport, and Xeomin primarily treat glabellar Lines and lateral orbital rhytids (crow's feet) but they've seen increasing usage around the mouth in some practices. (We do not recommend this unless you're extremely skilled since this can cause some serious problems if you paralyze someone's mouth.)
These treatments are restricted by licence although there have been a number of unlicensed individuals (like this horror story) where individuals were treating patients.
Let's take a look at each.
The big boy in the market, Botox or onabotiliniumtoxinA was approved for cosmetic use in 2002. Approved treatment areas are as follows: hyperhidrosis, migraines, and the neck and chin. It is not limited to those areas as there are other FDA Approved uses in the body (Blepharophasm, Strabismus, and Overactive Bladder). It is used off-label by some physicians to treat other areas.
In 5 major US Cities, the average price of a Botox treatment for a patient is around $400. Botox (10mu) is selling around $400-$525 according to some US physicians and based on pharmacy price but it's much cheaper outside the US. Units used differ depending on the treated area, with a recommended 20 Units for the Glabellar Area, 6 to 20 Units for the Forehead, 4 to 12 for the Crow's Feet.
Many patients find Botox as the most effective in making wrinkles disappear, most are satisfied with their treatments over time, with a 95% Satisfaction Rate among patients. Not all however are mostly satisfied with their procedure, because some have complained making their appearance worse, probably do to the fact that every patient with a new treatment becomes hyper-focused on the mirror. Still, don't be to quick to discount patient reported effects of unevenness, ptosis, and sagging.
According to Mukherjee (2015), Botox is expected to grow to $2.9 Billion by 2018 with the facial aesthetic market to balloon to more than $4 Billion, with the US contributing half of it. (Nice!)
The teenager Dysport (abobotiliniumtoxinA) entered the market in 2009 and has actually been giving Botox (Allergan) a respectable competitor. In its early release, many were skeptical about its efficacy, strengthening Botox' popularity among patients (possibly do to it's lower cost). However, many studies have shown that Dysport is a fast acting injectable as compared to Botox.
Why choose Dysport over Botox?
In a double-blind study conducted in 2011, Botox and Dysport were used to test ninety patients. Dysport was the better choice to treat crow's feet in the study. The dosage used in the study had 30 Units for Dysport, while 10 only for Botox.
On average, Dysport treatment costs $360 for some major US cities we looked at for Botox. As for the selling price of Dysport to physicians, it is at around $475-$800. According to some physicians, for treatment of crow's feet at least 30 units is used to treat one side, 20-80 for the forehead, and 40-80 units for the glabellar.
Dysport can be an alternative to those who do not find Botox effective. Some prefer Dysport as their neuromodulator of choice due to its longer efficacy. It has been said that due to lesser proteins, Dysport can easily be accepted by the body.
It has proven itself to be a worthy competitor against Botox with a 93% satisfaction rate by Dysport users. On the other hand, it is not all met with praise since it can cause the same side effects to patients that Botox can.
The new kind on the block. Among the three neuromodulators, Xeomin contains only incobotulinumtoxin A, resulting in some calling Xeomin the 'Naked Botox'. It has no proteins which both the two prior injectables contain, and it requires no refrigeration. Many observe that Xeomin has the slowest onset among the toxins, with results appearing 3-4 days after treatment.
In administering Xeomin, the needle is smaller and the injections are a few centimeters away from each other (less pain?). It also uses only around 10-25 units for one side for crow's feet treatment, 10-15 for the forehead, and 20 for the glabellar. Merz retails a bottle of Xeomin at $466, with some pharmacies selling it at a lower cost around $260 - $300. On average, the treatment of Xeomin to patients is around $355.
Xeomin showed great results for frown lines for most patients, but it's often rated slightly lower by patients in terms of satisfaction. This may be due to actual results, but it's also likely that differing injection techniques by new clinicians who have previous experience with Botox and Dysport, as well as less patient name recognition could be the cause.
As part of this series we're going to do some internal surveys and research into pricing and satisfaction across physicians. If you'd like to be involved and/or have access when we release these results, please make sure that you sign up as a member.
Read the sister post to this on filler injections pricing and satisfaction for clinicians.
Three cosmetic injectables are currently available in the market (Botox, Dysport, and Xeomin). A fourth one is shaping up as the next competitor against the botulinum toxins. Revance Therapeutics Inc. is gearing up to produce the newest in the botulinum toxin market. The daxibotulinumtoxina is the newest to gain interest.
The neurotoxin is currently undergoing trials since early 2016. It claims that it will have a longer effect on the face against those available in the market. A 2011 study have found the effects of daxibotulinumtoxina for injection (RT002), which shows its efficacy and longevity.
How would this affect the three existing neurotoxins?
So far, Botox is the popular choice of neurotoxin, it being the first and proven effective for treatment of glabellar and lateral canthal lines. Xeomin and Dysport treats Cervical Dystonia and the glabellar lines. Many have expressed their concerns with the existing neurotoxins, most specifically with the possible side effects (e.g. ptosis).
Why does it matter?
Revance will include a peptide technology called: TRANSMTS in their (what they claim) a highly purified botulinum toxin to produce a longer-lasting effect. Aside from treating any aesthetic concern, daxibotulinumtoxina will also treat plantar fasciitis--- which is also undergoing study— and cervical dystonia. The neurotoxin will also come in a topical form.
Peptides have been used also for some cosmetics, with some calling it as an alternative to Botox having anti-aging effects for the face. Most studies regarding peptides are focused mostly on cosmetic products (i.e. make-up).
Botox, Dysport, and Xeomin have been met with their own criticisms from patients and physicians. The daxibotulinumtoxina could be a game changer in the market. Trials are underway for the daxibotulinumtoxina. Not much can be said about the trials but so far, the sample has not experienced any serious or adverse effects. According to clinicaltrials.gov, the study for the efficacy of daxibotulinumtoxina will be released on 2018 at the latest.
References:
http://www.revance.com/pdfs/diffusion-and-duration-of-new-type-a.pdf
https://clinicaltrials.gov/ct2/show/NCT03014622?term=DaxibotulinumtoxinA&rank=4
https://clinicaltrials.gov/ct2/show/NCT02973269?term=DaxibotulinumtoxinA&rank=2
Nithya is a Hindi girls name meaning "always" or "eternally". It's bening touted as a year-long replacement for Botox with a different, and better, treatment mechanism.
There's an article from the UK discussing Nithya as Botox replacement. Link
Described as a 'truly unique form of pain-free anti-ageing treatment', Nithya, which is offered at Vida Aesthetics, is the first skin rejuvenation injectable made from equine-sourced protein available in the UK...
According to the clinic, results are long-lasting, and unlike wrinkle reduction treatments like Botox, which paralyse the muscles and dermal fillers, Nithya apparently works 'in harmony' with your natural tissue structure. The clinic say it lasts a year, whereas Botox lasts around four months.Eddy Emilio, Director of Vida Aesthetics, who is pioneering the treatment, says the launch of Nithya is already proving popular with his clients.'This exceptional collagen-boosting product is proven to be safe, has had no reported side effects, is hypoallergenic and gives excellent results. We truly believe this could rival the results of established but overused anti-ageing cosmetic treatments,' he said.'This is the only commercially available Type I collagen intended for aesthetic use in the country, and we’re already getting rave reviews from cosmetic doctors thanks to its excellent results and numerous areas it can improve the appearance of.'The idea of using protein sourced from horses may seem quirky, but we’re certain this is the future of anti-ageing!'
Described as a 'truly unique form of pain-free anti-ageing treatment', Nithya, which is offered at Vida Aesthetics, is the first skin rejuvenation injectable made from equine-sourced protein available in the UK.
The £250 skin plumping treatment is apparently designed to holistically improve the production of new collagen, helping to ease fine lines around the eyes and improve facial volume in areas such as the cheeks.
Described as a 'truly unique form of pain-free anti-ageing treatment', Nithya, which is offered at Vida Aesthetics, is the first skin rejuvenation injectable made from equine-sourced protein available in the UK.
According to the clinic, results are long-lasting, and unlike wrinkle reduction treatments like Botox, which paralyse the muscles and dermal fillers, Nithya apparently works 'in harmony' with your natural tissue structure. The clinic say it lasts a year, whereas Botox lasts around four months.
Eddy Emilio, Director of Vida Aesthetics, who is pioneering the treatment, says the launch of Nithya is already proving popular with his clients.
'This exceptional collagen-boosting product is proven to be safe, has had no reported side effects, is hypoallergenic and gives excellent results. We truly believe this could rival the results of established but overused anti-ageing cosmetic treatments,' he said. 'This is the only commercially available Type I collagen intended for aesthetic use in the country, and we’re already getting rave reviews from cosmetic doctors thanks to its excellent results and numerous areas it can improve the appearance of.
'The idea of using protein sourced from horses may seem quirky, but we’re certain this is the future of anti-ageing!'
The Vida Aesthitic clinic has some before and after photos posted here
From Vida Aesthetics site:
(Nithya) Is a Class III medical device. It is a heterologous Type I collagen powder which stimulates the production of new fibroblasts to create native Type III collagen, a process that is fundamental in cosmetic medicine and anti-aging treatments. In the form of a lyophilized collagen patch, this product has been used for almost 30 years and is still successfully used today to affect the healing of skin ulcers, open wounds, scars and bedsores.
Each package consists of a glass bottle containing equine type I collagen in powder form, sterile and pyrogen-free.
Is safe, with no reported side effects, is hypoallergenic and gives excellent results. Used in combination with lidocaine, the surgery procedure is virtually painless and is the only commercially available Type I collagen intended for aesthetic surgery. The product bears the CE 0373 mark.
It produces the optimal conditions to restore connective tissue. It supplements dermal bio-revitalization and assists the regeneration of connective tissue in the dermis proving perfect conditions for the physiological neo-formation of collagen. Can be used for body and facial chrono- and photo-aging treatments.
Packaged for single use and must be placed in suspension immediately before use in WFI (Water For Injection) at a ratio of a vial of collagen to 5 ml of WFI. Once in suspension, the product should be used immediately and any remaining following the treatment should be discarded. Using the appropriate size needles from 32G x 2 mm up to 30G x 4 mm, the product is administered through intradermal infiltration by medical practitioners licensed to carry out such treatments. The technical skill of the practitioner is key to the success of the treatment so it is recommended that the practitioner receives specific training on the mesotherapic injection technique.
Vida Aesthetics is also offering Nithya injectable training: Link
The current standard seems to be 30-gauge needles for Botox, buta recent study shows that 33-gauge needles caused less pain.
(Investigations related to clinical needle derived pain also demonstrate that needle size is not the only factor affecting patient comfort level. In addition, the mechanics of needle insertion has been found to significantly affect pain. Both the force and the mechanical workload (i.e., area under the force-displacement curve) of hypodermic needle insertion have been found to positively correlate with the frequency of pain. Thus, needle tip sharpness and other factors, such as lubrication, which can reduce the force of insertion and mechanical workload, and pre-treatment with a topical anesthetic are important parameters that can be optimized to reduce pain from needle insertions.)
From the study:
The highest level of pain was in the malar region, and the lowest level was in the glabella. Although all pain scores were lower for the 33-G microneedle, the difference was significant only for the forehead. Because most minimally invasive procedures require multiple injections during the same sitting, the overall procedure was evaluated as well. Assessment of the multiple-injection process demonstrated a significant difference in pain level, favoring the 33-G needle. Although the difference in bruising was not statistically significant between the two needles, the degree of bruising was lower with the 33-G needle.
Conclusions: For procedures that involve multiple injections to the face (such as mesotherapy and injection of botulinum toxin A), thinner needles result in less pain, making the overall experience more comfortable for the patient and the physician.
There are a few other studies that show similar results and there are some contradictory findings from a study in 2010.
References:
1. The Effect of Microneedle Thickness on Pain During Minimally Invasive Facial Procedures: A Clinical Study. . Aesthetic Surgery Journal. 1 July 2014 Billur Sezgin MD, Bora Ozel MD, Hakan Bulam MD, Kirdar Guney MD, Serhan Tuncer MD, Seyhan Cenetoglu MD
2. Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin Type A Injections: A Randomized Clinical Trial. JAMA Dermatol. 2015 Nov;151(11):1194-9
3. Dermatol Surg. 2010;36(1):109-12. Needle preference in patients receiving cosmetic botulinum toxin type A. Price KM1, Williams ZY, Woodward JA.
4. Egekvist H, Bjerring P, Arendt-Nielsen L. Pain and mechanical injury of human skin following needle insertions. Eur J Pain. 1999 Mar;3(1):41-49.
5. Egekvist H, Bjerring P, Arendt-Nielsen L. Regional variations in pain to controlled mechanical skin traumas from automatic needle insertions and relations to ultrasonography. Skin Res Technol. 1999;247-54.
6. Schneider LW, Peck LS, Melvin JW. Penetration characteristics of hypodermic needles in skin and muscle tissue. Phase I (Appendices B-E). Final report. Highway Safety Research Institute, Ann Arbor, MI; 1978
7. Dermatol Surg. 2005 Dec;31(12):1655-9. Single-center, double-blind, randomized study to evaluate the efficacy of 4% lidocaine cream versus vehicle cream during botulinum toxin type A treatments. Carruthers A1, Carruthers J.
Originally published on LinkedIn by Michael Greenspan. Link
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:
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
Our lips provide competence to the oral cavity when we chew our food. They may also affect sounds and facilitate facial expression which help us communicate what we feel. Lips also have their own aesthetic value.
Earlier this year, the Kylie Jenner Lip Challenge went viral on the internet. People who took the challenge sucked the air out of a glass to create fuller lips that is said to be more attractive. Of course, everything did not go well for others because many attempts ended in painful bruisings and trips to hospitals.
Sucking glass cyclinders did not make Kylie's lips look plump - it was cosmetic enhancement that did it. In an interview with Cosmopolitan magazine, she admitted using a filler and advised others who want a similar look to try a filler that lasts about two to four months, in case they change their mind and want to give it up.
For dermatologists and Medspa owners who work with patients desiring for plump lips, giving advice to patients during patient consultation may boost patient satisfaction rate.
A study in Germany was conducted "to clarify what it is that makes lips attractive - and whether there are gender-related differences of an attractive lip and lower third of the face".
After patients' lip and chin regions were photographed and evaluated by voluntary judges through a Likert scaling system, the results showed that there were certain parameters of the lips that add attractivity of both male and female individuals. Further, gender-related differences were manifested in the form and shape of an attractive lower third of the face.
Read more on: http://www.jprasurg.com/article/S1748-6815(15)00137-0/abstract
Lip filler hyaluronic acid may be useful for people with facial paralysis.In an interesting use case for the fillers in use at every cosmetic clinic,... A small research study conducted at the Johns Hopkins and Stanford universities reveal that aside from hyaluronic acid's use in cosmetic surgery, it may be useful for patients who struggle with drooling, eating, and drinking because of lack of lip control due to facial paralysis.
According to Kofi Boahene, M.D., a facial plastic and reconstructive surgeon in the Department of Otolaryngology-Head and Neck Surgery at the Johns Hopkins University School of Medicine, facial paralysis causes both both physical and psychological problems among patients making them self-conscious about how they look.
Boahane has used the analogy of a plant filling its leaves and stems with water to maintain structure. He says that
It’s a crude analogy, but injecting the lips with hyaluronic acid works in much the same way. It tones the tissue surrounding the muscle.
Boahene was working on a patient with then-undiagnosed case of muscular dystrophy when he had his own eureka moment. He stumbled across a possible role for hyaluronic acid injection to improve a patient's lip muscle tone. After trying the injection, the patient's face appeared stronger and her articulation improved.
Boahene and his collaborators tested 22 more patients with facial paralysis. His team got the participants' baseline measure of lip tone and the weakest points were identified by having them blow air with pursed lips. The researchers injected hyaluronic acid at the point where the air escaped.
After the procedure, he said that the patients showed marked improvement as confirmed by a speech therapist who conducted the assessment. Boahene further adds that the injection may last up to a year when done for cosmetic improvement.
Because lip augmentation and injection is a minimally invasive procedure, a plastic surgeon or dermatologist may perform such procedures. However, Boahene mentions that it is advised that the lip injectionsbe done by physicians who are experienced with treating muscle weaknesses and facial paralysis.
Read more on:
http://ictr.johnshopkins.edu/news_announce/cosmetic-surgery-drug-to-treat-facial-paralysis/
I have been an avid user of Belotero Balance for a few years in my cosmetic injection practice. Last month (April 2015), I injected 4638 units of Botox and 75 syringes of fillers. 20% of the fillers I use is Belotero Balance. Much of what I do with Belotero is considered off-label FDA use. I am a frequent user of cannulas in my filler practice which includes the spectrum of Juvederm available in America and Radiesse.
I spend half of my clinical time personally performing cosmetic injections. I think I would be a bit busier if I spent more time on the Botox/filler side of the practice but I have plastic surgery assisting duties (my wife is a plastic surgeon, I am a general surgeon with trauma experience), a small cosmetic vein practice, and I also have an acupuncture practice which I love. After clinical hours, I am an administrator for our plastic surgery practice. I feel that I spend about 80 hours per week on our practice clinical+administrative.
I use a cannula and lay down Belotero for tear troughs. It works well for many tear troughs, and flows very well through a cannula. I've learned over the years to tell the patients that the duration in that area seems to average about 6 months. Of course this varies from patient to patient. I was a Juvederm user for almost all tear troughs before and ran into some trouble with swelling for a few patients. I still run into some swelling issues with Belotero but it is much less. It also works well for building up a little bit of the cheek above the zygoma laterally.
Some fine forehead lines are amenable to Belotero filling. It is especially useful for those patients who want a smoother forehead with less brow drooping which can happen with overzealous Botox use on the forehead. It is also great for those wrinkles in the eyebrows.
Belotero is wonderful just as a small touch to a slight downturn in the oral commissure. I'm not talking about the entire marionette line, but just the corner of the mouth and injected superficially.
I need to be careful with the bruising in this area but it works well for some of the fine crows feet lines. It works well with Botox to battle those static lines.
Those horizontal lines - belotero becomes very labor intensive but well worth it. The patients get a bit of bumpy look for the first 2-3 weeks, but it settles and the Belotero works well to integrate into the skin. I'm not talking about platysmal bands - in that case - look to Botox.
Or some call it decollatage area. These chest crinkles smoothes out well with Belotero well. For many patients, I have to bend the needle to get the angle I need - especially for the ones where my wife had performed breast augmentation. And it would be useful to have a chaperone in the room for these procedures.
Yes, this is useful, and can at times reduce bruising because the needle doesn't go in very deep. A wrinkle is injected several times about 2 mm apart and the needle just barely goes into the skin. For most of what I like to do with Belotero, except for the tear troughs, I am injecting very superficially. If I'm threading the needle through (ie, in neck lines), I can see the needle through the skin. This superficial needling probably has an added collagen induction characteristic for the patients - similar to microneedling.
Superficial injections lead to longer lasting effect. I have found that deeper injections in areas with movement seem to eat up the Belotero in 3 months. But 5-6 months can be derived from superficial injections.
I like Belotero and would recommend it as part of our creative set of tools for beauty. It's like a very thin paintbrush. And Belotero works well with other fillers in a layered approach. Belotero has lasting effect when injected very close to the skin and when injected into areas with minimal movement. And it doesn't seem to have a bluish tint under the skin.
Calvin Lee, MD
At least that's a recent BBC headline that might be more link-baiting than actual research.
According to the UK's Journal of Aesthetic Nursing, clinicians say there is a growing trend for under-25s to seek the wrinkle-smoothing injections but research suggests "frozen faces" could stop young people from learning how to express emotions fully. Additionally, a leading body of UK plastic surgeons says injecting teenagers for cosmetic reasons is "morally wrong".
What's going on here?
Nurse practitioner Helen Collier, who carried out the research, says reality TV shows and celebrity culture are driving young people to idealize the "inexpressive frozen face."
But she points to a well-known psychological theory, the facial feedback hypothesis, that suggests adolescents learn how best to relate to people by mimicking their facial expressions.
She says: "As a human being our ability to demonstrate a wide range of emotions is very dependent on facial expressions.
"Emotions such as empathy and sympathy help us to survive and grow into confident and communicative adults."
But she warns that a "growing generation of blank-faced" young people could be harming their ability to correctly convey their feelings.
"If you wipe those expressions out, this might stunt their emotional and social development," she says.
Dr Michael Lewis, a researcher in psychology at Cardiff University, says: "The expressions we make on our face affect the emotions we feel.
"We smile because we are happy, but smiling also makes us happy.
"Treatment with drugs like Botox prevents the patient from being able to make a particular expression and can therefore have an effect on our learning to feel emotions naturally."
Rajiv Grover, president of the British Association of Aesthetic Plastic Surgeons, says: "Injecting teenagers with Botox for cosmetic purposes is morally wrong and something that no ethical practitioner would do.
Of course this might have been morea bout Ms Collier's presentation at the Clinical Cosmetic and Reconstructive Expo and generating a little visibility for both the presenter and the venue.
I tend to agree with many of the premises here in that cosmetic treatments simply to cater to perceived imperfections for younger patients just shouldn't be performed, but it seems a stretch to say that the Botox is the cause rather that the effect. In the patients that I've seen that fall into this age group and are looking for cosmetic treatments there are already many factors that are contributing to this behavior in the first place rather that flowing from previous treatments.
Body dysmporphic disorder in the young is something that every cosmetic practioner runs into from time to time. It's up to each clinician to understand what the patient psychology is and how best to address it. Blaming the actual treatments is overly simplistic in my view.
Photo: Wikipedia“The FDA has become aware of adverse events associated with the unapproved use of the Expression product as a dermal filler,” reads the warning. “The FDA has not approved this product for use as a dermal filler and recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance.”
Manufactured by Enhancement Medical, Expression was approved by the FDA in 2012 as an intra-nasal splint to be used after nasal surgery. According to Enhancement Medical, it’s a "third-generation hyaluronic acid gel" that’s sulfite- and pathogen-free.
Unlike Juvederm, Restylane, Perlane, and other commonly used hyaluronic acid products, which are FDA-approved for cosmetic use, Expression is being used off-label. (Off-label use is common and not illegal. Botox was used for years off-label to treat wrinkles, migranes and sweating for which it had not yet been approved.) Nevertheless, in the past couple of years Expression has come into wider use by doctors and cosmetic clinics. The number of growing treatments has resulted in a correstponding increase in complaints.
In Feburary 2014 the FDA first contacted Enhancement Medical regarding complaints of adverse reactions and in June sent them a warning letter criticizing them for what the FDA perceived as inadiquate follow-up and investigation as well as using the term "filler injection" in the copy on their web site.
The FDA says that there are adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.
Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material.
The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection.From the FDA letter:
FDA also reviewed your firm’s medical device registration and listing, which lists the Expression as a Class I exempt intranasal splint. Generic devices classified under 21 CFR 874.4780 (Intranasal Splint, Class I) are intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma.
We note, however, that FDA is aware of and has reviewed multiple documents for Expression that contain claims, phrases and/or statements that refer to your firm’s device as an “injectable filler.”
For example, during FDA’s recent inspection, your firm provided the Investigator with a document entitled “The Science Behind Expression” which contained the following statements:
- “Enhancement Medical is using the new pathogen-free, raw HA material to develop and manufacture Expression™ injectable filler in Wauwatosa, Wisconsin.”
- “Enhancement Medical uses the raw HA product from Novozymes as a non-toxic and non-pathogen delivery medium for its Expression™ injectable filler.”
- “In formulating Expression™, the HA molecules are cross-linked with divinyl sulfone (DVS) and the gel is swelled to equilibrium. This provides the Expression injectable filler product with an 80/20 gel to fluid ration with up to 26 mg/mL of HA. Thus the formulation combined with the highly robust HA molecules result[s] in a very rich and potent filler compared to others.”
- “Clinicians find Expression™ does not have the hydrophilic effect when placed into tissue, eliminating guesswork from corrections and providing greater utility for multi-purpose use.”
As stated above, under 21 CFR 874.4780, intranasal splints are placed into the nasal cavity after surgery or trauma. Intranasal splints are not intended for injection through intact skin or mucosa and placement into tissue. Injection through intact skin or mucosa and placement into tissue may raise new questions of safety and effectiveness that could require either premarket approval and/or clearance before the device may be marketed in the United States. Please provide us with the basis for your identifying Expression as an “injectable filler” and whether you intend to continue making such claims. See 21 CFR 874.9(a) (limitations on exemption – promoting your device as an injectable filler may indicate a different use which could cause it to no longer be 510(k) exempt).
Additionally, FDA has noted that your firm’s website (www.enhancementmedical.com) contains the following statement for the Expression injectable filler: “Expression has FDA indication for use as intranasal splint.” Please be advised that this statement may be confusing to users and could create an impression of official approval of your device. As such, we request that your firm please remove any reference that FDA has indicated your device, Expression, for a specific use.
The response from Enhancement has been to recall all lots of Expression.
According to the recall letter the company received 99 complaints from 14,835 syringes shipped with compaints that included "swelling, redness, pain, bumps, firmness, bruising, itching, inflammatory reactions, infections and abscesses".
The letter continues, "We do not recommend that Expression be injected subcu-taneously for any reason because Expression’s safety and effectiveness as a subcutaneously administered substance has not been established in controlled clinical studies."
What's interesting here is that the list of complaints are pretty much exactly what you'd expect with any filler like Juvederm or Restylane. I'm wasn't able to find anything online that would call out Expression as having reactions that are abnormally high (althought they might be). If anyone has relevant stats please leave a comment below.
In any event, you'll want to send back your recalled Expression if you've been using it.
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