You asked; we listened! In a recent reader survey many of you asked specifically for review and coverage of clinical research and issues. Based on your feedback, we are excited to announce a new biannual series of articles that will summarize top aesthetic peer-reviewed literature, enhanced with commentary by an author. Two times per year we’ll share two to three top articles, chosen by the editors-in-chief of some of the most renowned journals in our industry. To kick off this new column, we are featuring two profound offerings, one from The Journal of Cosmetic Dermatology and one from the Aesthetic Surgery Journal.
Cutting Through the Haze Surrounding Injectable Neurotoxins
Injectable botulinum toxin, and its impact on aesthetic medicine, require no introduction. Products have been on the market for decades and new offerings continue to emerge. Manufacturers have funded an evolving body of scientific literature that establishes injectable neurotoxins firmly among the most well-studied therapeutic modalities in aesthetic medicine, but is it truly well-understood?
The reality is summed up in the abstract of an August 2020 review article by Nestor and colleagues1 published in The Journal of Cosmetic Dermatology (JOCD): “The literature on botulinum toxin type A (BoNT-A) is extensive, often contradictory and confounded by a competitive market of product and research attempting to distinguish brand individuality.”
Mark S. Nestor, MD, PhD
Bringing further clarity to the murky waters, the JOCD article updated the Eight Key Clinical Postulates first presented in a 2017 article in Dermatologic Surgery,2 providing in-depth review of the literature and suggesting avenues for further study. It is a must-read for any physician interested in or actively injecting neurotoxins for aesthetic indications.
Lead author Mark S. Nestor, MD, PhD, is director of the Center for Cosmetic Enhancement as well as the Center for Clinical and Cosmetic Research, both located in Aventura, Fla. “We need to understand the science behind botulinum toxin so that we can assess the properties of different type-A toxins, in order to optimize patient care. This will help us differentiate between what the toxin does, what we do, and how we get the best outcomes putting this knowledge into practice.”
The updated postulates are listed in Figure 1. “The first key issue is Postulate I, that all type A toxins act identically,” Dr. Nestor explained. “The real difference between the products is what we’ve termed ‘molecular potency’ which is the actual number of 150 kDa molecules that are active, free, non-compromised and available to bind. It is kind of like octane rating for gasoline. That value is the key because all type A toxins are the same otherwise.
Different toxins have different amounts of 150 kDa molecules for the approved units for glabella, for example, and manufacturing procedures may make a product more or less aggregated; less aggregated means there is more available to bind.”
Another vital issue put forth is the importance of cost per molecular potency unit. “In the article we call this the molecular potency quotient,” he said. “This is difficult to assess because each toxin has proprietary units, and the trials are so often constructed differently with different assessments, different standards, different investigators and different methods of injection. Bear in mind that we are talking about toxins that we have established are basically the same. What we have is a huge body of literature whose value is limited by these confounding differences.”
The article also shared about how differing patient characteristics impact the result, as well as how and why specific injection techniques maximize the result by using less toxin more effectively. “Muscle mass, age and genetics – how many receptors are available and how the body recovers from the introduction of toxin – all play a role. What we do also matters. ‘Spread’ impacts the result, which is affected by reconstitution, needle size and injection technique – the direction and number of injection points, speed of injection and how we are distributing the toxin.”
“There is a lot of confusion surrounding ‘diffusion,’” Dr. Nestor continued. “Spread isn’t diffusion, which is passive and is the same for all toxins. The area of effect is the important clinical parameter and is determined by two things, the spread and the molecular potency. We use the example of sugar dropped from a height onto a surface. If you have more sugar, the pile will have a wider diameter because there’s more sugar.”
The original article Cutting Through the Haze Surrounding Injectable Neurotoxins, is open access and available online at https://onlinelibrary.wiley.com/doi/10.1111/jocd.13702
1. Nestor MS, Arnold D, Fischer D. The mechanisms of action and use of botulinum neurotoxin type A in aesthetics: Key clinical postulates II. J Cosmet Dermatol 2020;19:2785-2804.
2. Nestor MS, Kleinfelder RE, Pickett A. The use of botulinum neurotoxin type A in aesthetics: key clinical postulates. Dermatol Surg 2017;43:S344-S362.
Making the Brazilian Butt Lift Safer: Is Anyone Listening?
With the explosion of the Brazilian Butt Lift (BBL) procedure came the unfortunate, but not unforeseeable, side effect of overhyped, underqualified personnel attempting to capitalize on its popularity. What was not foreseen was that even among reputable practitioners of the procedure, the rate of complications and mortality was shockingly high. To curtail this, a series of treatment guidelines to maximize safety was put forth by the Aesthetic Surgery Education and Research Foundation (ASERF) and published in 20171. However, did surgeons adopt the new protocols, and did these recommendations help improve the mortality rate of BBL?
Luis M. Rios, Jr., MD Director Rios Center for Plastic Surgery Edinburg, TX
A 2020 study in the Aesthetic Surgery Journal2 shed light onto whether surgeons were aware of – and hopefully adopting – the new guidelines, as well as uncover the potential effect, if any, on the mortality rate. Plastic surgeon and lead author Luis M. Rios, Jr., MD, is director of the Rios Center for Plastic Surgery (Edinburg, Texas) and the current president of ASERF. He served on the ASERF board of directors when the initial study was published. “In 2015 one of our board members from San Diego, Calif. received reports from the LA county coroner about deaths associated with the procedure, so ASERF put together a task force. This task force published a paper demonstrating that the mortality rate of BBL was higher than abdominoplasty, the riskiest aesthetic procedure at the time. The paper also established recommendations on techniques that could significantly reduce the risk of pulmonary fat embolism (PFE), the main cause of mortality.”
These recommendations included the use of cannulas greater than 4 mm, avoidance of downward angulation of the cannula penetration and avoidance of muscular injections with only injection of fat into the subcutaneous space.1 “These findings were eye-opening, as the procedure was relatively new but increasingly popular, and, surprisingly, the negative aspects of these findings did not significantly hamper the prevalence of the procedure. However, the 2017 study was one of the most widely read articles published at that time, and some surgeons stopped doing BBLs entirely.”
As in the original 2017 study, ASERF conducted an anonymous survey among members of the The Aesthetic Society and the International Society of Aesthetic Plastic Surgery (ISAPS) comprised of the 15 closed-ended questions used in the initial 2017 survey, and adding 14 more to ascertain awareness, as well as adoption, of the new techniques put forth in the 2017 paper. Respondents were also asked about the number of fatal and non-fatal PFEs in their career and over the last two years since the ASERF recommendations were published. Of 5,048 members polled, 572 completed surveys (11.3%) were included in the 2020 study, somewhat less than the 14.3% response rate to the 2017 survey.
Results showed a decrease from 1 PFE per 1,030 procedures in 2017 to 1 in 2,492, with concurrent decrease in mortality from 1 in 3,448 in 2017 to 1 in 14,952. Of the respondents, 94% reported awareness of the recommendations. Other results showed dramatic decreases in the use of techniques that went against the ASERF guidelines. All told, this strongly suggests that not only were surgeons aware of the new guidelines, they were adopting them, with subsequent effect reducing the mortality rate.
Commentary by Oppikofer3 highlighted the importance of recognizing the limitations of the study – the main ones being the question of correlation between survey respondents (members of ASAPS and ISAPS) versus the plastic surgery community, and inherent response bias from those seeking to showcase their adoption of the new techniques. The commentary author admitted that nevertheless, the results were encouraging. “We used the tools at our disposal at the time, and there are definite limitations, but we believe these results do show that physicians are both aware of the 2017 recommendations and putting the new guidelines into practice for better, safer procedures,” Dr. Rios responded. “We are not finished, we currently have a software platform in the works that will help us anonymously assemble data, in a HIPAA-compliant way, directly from physician office electronic medical records, which will give us better data for future studies such as this one.”
“In 2017, the tummy tuck was probably the riskiest aesthetic procedure and we discovered that BBL was much more so. Now, BBL may be less risky, but overall, it is a procedure best left to experts, such as well trained and experienced members of the Aesthetic Society and ISAPS,” he added. “If you are not going to do a lot of them, perhaps you shouldn’t be doing them at all.”
The Aesthetic Surgery Education and Research Foundation (ASERF) has provided the funding for the original article.
* This material was originally published in Improvement in Brazilian Butt Lift (BBL) Safety with the Current Recommendations from ASERF, the American Society for Aesthetic Plastic Surgery (now The Aesthetic Society) and ISAPS by Luis Rios, Jr, MD and Varun Gupta, MD, MPH, and has been reproduced by permission of Oxford University Press https://academic.oup.com/asj/article/40/8/864/5822125?searchresult=1
For permission to reuse this material, please visit http://global.oup.com/academic/rights.
1. Mofid MM, Teitelbaum S, Suissa D, et al. Report on mortality from Gluteal Fat Grafting: Recommendations from the ASERF Task Force. Aesthet Surg J 2017;37(7):796-806.
2. Rios L, Gupta V. Improvement in Brazilian butt lift (BBL) safety with the current recommendations from ASERF, ASAPS, and ISAPS. Aesthet Surg J 2020;40(8):864-870.
3. Oppikofer C. Commentary on: Improvement in Brazilian butt lift (BBL) safety with the current recommendations from ASERF, ASAPS, and ISAPS. Aesthet Surg J 2020;40(8):874-875.