Fillers have become widespread and have become really in demand in the practice of a cosmetologist. Specialists appreciate them for ease of insertion, and patients – for the clarity of the procedure and the speed of the onset of a rejuvenating result. But against the backdrop of laudatory reviews, the area of long-term influence of fillers on the body, the validity of their administration and the mechanism of influence on tissues, as well as many other issues related to the use of fillers in cosmetology.
The problem of using fillers seems extremely interesting in several aspects at once. Due to many factors, namely: the interest of patients in the correction of aesthetic defects that appear with age, the fundamental ease and clarity of the filling procedure, a rather active advertising campaign of manufacturing companies – fillers have become widespread and have become truly in demand in our practice.
But at the same time, a number of questions have arisen, which no one seems to be trying to answer. Against the background of constant laudatory reports on the action of one or another filler in the world scientific literature, there are literally single works devoted to the tissue response, the study of stage-by-stage morphological changes depending on the localization of the introduction and the nature of this or that filler. A mild antagonism between plastic surgeons and cosmetologists is also clearly visible. Among the former, there is often an opinion that fillers, being camouflage means, should be as limited in use as possible. The latter have a diametrically opposite point of view, suspecting surgeons that they often offer a surgical method of correction in cases where it would be possible to get by with a low-impact injection of fillers.<
We offer readers a discussion in which practitioners in the field of aesthetic medicine took part:
Evgeny Laputin, Head of the Surgical Department of the Clinic of Aesthetic Medicine "Detal" (Moscow),
Vladimir Vissarionov, Doctor of Medical Sciences, Professor, Director of the Institute of Plastic Surgery and Cosmetology of the Ministry of Health of the Russian Federation;
Elena Gubanova, MD, dermatologist, cosmetologist, leading specialist in injection techniques at Vallex M;
Thomas Sleyter, Esthetic Dermatologist in private practice (New York, USA).
This discussion will touch upon a number of issues, the clarification of which, firstly, is of some interest, and secondly, it is certainly useful for both doctors and patients.What is the essence of the problem, and how would you characterize the state of the issue today
Vladimir Vissarionov: Since a foreign body is introduced into the tissues, in my opinion, the most important task for clinicians and material developers is to study the interaction of tissues with this foreign body. If the injected substance is absolutely inert, the purpose of the injection can only be to fill the missing volume.
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Otherwise, the injection of the filler should cause chronic irritation and stimulate the production of its own tissues. The problem is in an objective assessment of the synthesized material from the standpoint of safety, the possibility of a long stay in tissues without complications, and in the event of the latter – development of treatment tactics.
Elena Gubanova: The main tasks facing manufacturers, distributors and doctors can be the following: prolongation of the resorption period of semi-permanent and resorbable gels; study of long-term interactions of permanent fillers with tissues; assessment of long-term results and complications; search for optimal safe combinations of fillers; the need for multicenter trials of new drugs; quality training of specialists; discussions and exchange of clinical experience; legal protection of the doctor and the patient.
Thomas Slater: Due to the relatively recent introduction of fillers as components of complex treatment of facial contouring defects, as well as the fact that the market is replenished with new drugs, doctors and patients have unreasonable optimism regarding these drugs. The ease of their introduction, the speed of the recovery period, the relative safety of the entire procedure and the aggressive advertising of manufacturers lead to a clearly overestimated capacity of fillers.
Choose the right fillers: calculate the expected effect
At the same time, problems are bashfully hushed up: lack of knowledge of long-term results, cases when, for unknown reasons, the effect lasts much shorter than the expected period, unpleasant focal side effects, for example, in the form of fibrosis, etc. Therefore, the main question for today, it seems to me, is the following: are fillers a fashion or, indeed, a non-alternative need for treatment, for which the doctor has the right to take certain risks.
Evgeny Laputin: The main problem with the use of fillers is the glaring discrepancy between the benefits claimed by the manufacturers and the real results. At the turn of the 1990s-2000s, I conducted a detailed survey of patients who underwent contour plastic surgery using various fillers. Without taking into account the opinions of those who were completely dissatisfied with the results of contouring therapy, among the "satisfied", however, those who noted "a clear improvement, but not in the way we would like" and those who said that the result lasted for a deadline that is completely incomparable with the expected.
So, with Restylane, I have repeatedly seen cases where the effect lasted only a few weeks! Involuntarily, in this case, the doctor turns out to be a money-grubber and a deceiver, and the patient – cheated victim. When analyzing the scientific literature, it is noteworthy that only the local effect of the drug is studied without assessing the overall response of the body, although it is the peculiarities of the general metabolism that are (presumably?) the main reason for the brevity of the action.
When a new material appears, the manufacturer necessarily declares certain advantages of its product. At the same time, the doctor finds himself in a very difficult situation and inevitably becomes a hostage of a situation where, on the one hand, he is already used to the fillers he worked with before, on the other hand – afraid of missing out on a better product and doesn't want to be seen as a conservative.
This pushes the doctor to use new materials, with a high probability that they can turn out not only not better, but even worse than the drugs used before. The opposite is also possible: while receiving satisfactory results, the doctor is completely blind to all the novelties. What is the optimal tactic in such a situation?
Vladimir Vissarionov: Yes, of course, the creation of new fillers in itself reflects the dissatisfaction of clinicians and their desire to achieve maximum effect without complications. However, in some cases it is difficult to say after what period of time and under what conditions the complication will arise. Both the patient and the doctor face a dilemma: what to choose? Naturally, in the end, the patient makes claims not to the developer and manufacturer, but to the doctor.
This may explain the doctor's preference for any drug. Moreover, the fewer complications there are, the less the doctor's interest in new materials will be. The procedures for implantation of fillers themselves are very scrupulous, and the development of a new drug requires a lot of time. The only, in my opinion, the right solution to expand professional horizons is to hold conferences and round tables with a limited number of participants (up to 50 & ndash; 60 people), where all the subtleties of clinical problems could be discussed.
Which fillers to use in gynecology
Any drug entering the market of cosmetic products must be certified. Clinical approbation should be carried out with a clear observation protocol in 3-4 clinics, while the observation period should be increased. On this issue, it is necessary to work with the relevant organizations at the level of the Ministry of Health.
Elena Gubanova: Any inquisitive medical practitioner periodically tries new products, wanting to have his own opinion and hoping that the new drug will be not only better, but, perhaps, more economical. Of course, each doctor will form his own principles of selection and preferences. The optimal position for careful practice – expectant. At least a year or two should pass from the moment of conducting clinical trials of a new resorbable material, scientific publications on comparative studies with a safety report published by well-known experts should appear. Important protection for doctor and patient – official registration in the country, awareness of the risk of developing long-term complications and the legal liability of manufacturing companies in case of serious complications.<
Thomas Slater: This is a good question, especially for an American doctor, because we are far behind Europe in the range of fillers, preferring bovine collagen for a long time, and only from scientific articles and from the words of patients from Europe recognizing about other preparations, for example, based on hyaluronic acid. Expanding our capabilities in this matter will inevitably increase our risks. Therefore, the most rational line of conduct is healthy conservatism and careful progress. Although, if a doctor today is generally satisfied with his results when using a particular drug, then it is hardly worth experimenting with something new until a fundamentally new and revolutionary filler is proposed.
Evgeny Laputin: I do not quite agree with Dr. Vissarionov that the creation of new fillers is mainly based on the dissatisfaction of clinicians. If we consider the issue in this aspect, then, rather, the dissatisfaction of patients can be a catalyst in the process of searching for new materials. I think it's something else – low cost and high market price encourage manufacturers to release more and more new drugs. Some of them are very aggressively advertised and marketed. This, of course, is hyperbole, but with the right advertising positioning, chicken droppings can also get into the range of fillers. I also disagree with both Dr. Vissarionov and Dr. Gubanova that the availability of permits (for example, from the Ministry of Health) can make the situation easier. For example, in the United States, hyaluronic acid fillers were belatedly introduced due to the position of the FDA, but no one doubted that they were quite comparable in quality to bovine collagen-based drugs. I understand that this is against the law, but the lack of registration from the Ministry will not stop me from using any filler that has a good reputation in the world and is carefully covered in the scientific literature (by no means do I mean new drugs from unknown companies). In this case, of course, the patient must be informed.
As for the drugs we have at our disposal, I don't see much difference in the effect of filling tissue depression of one or another genesis, so the relentless search for "something new" seems unreasonable to me. The main requirement when choosing a drug – the presence of scientific articles devoted to its comprehensive study, and the absence of toxic ingredients. The presence of the safety report referred to by Dr. Gubanova does not seem to me sufficient justification for the use of this or that material.
Our patients demand from us, first of all, a visual effect, and the data of morphologists, histologists and other specialists do not clarify the picture at all.
What are the benefits of using fillers other than volume remodeling
For example, are there any objective clinical improvements associated with the principle of isovolemic degradation characteristic of hyaluronic acid preparations?
Elena Gubanova: I can only rely on my own clinical experience in assessing the slowing down of aging in facial depression zones and on the positive feedback from patients over the course of eight years.
Thomas Slater:The use, especially repeated, of fillers in the same area leads to the formation of reactive fibrosis, which in some cases can camouflage tissue involution. I don't think that the components of the fillers are able to favorably affect the perifocal tissues. First of all, the filler acts as a mechanical filler.
Evgeny Laputin: Dr. Gubanova makes a rather attractive argument with which I would like to agree. But to confirm its correctness, it is necessary to have at your disposal a statistically significant group of patients (at least several dozen) who would agree that, for example, a filler was introduced into one nasolabial fold, and into the other – nothing. After that, they would have to agree to a multi-year examination, and then die, so that morphologists would comparatively study the tissues on both sides of the face. As far as I know, no such work has been carried out. Are there any downsides to all types of fillers other than high cost and rapid degradation
: All fillers have one flaw – no long-term observations. However, it is unlikely to be overcome without testing the effects of fillers at the cellular level.
Elena Gubanova: I absolutely agree with Dr. Vissarionov. Thomas Slater: Evaluation of the objective negative features of fillers is possible only by studying the biopsy material of the area where the implantation was made. But I have little idea how I can persuade my patient to agree that I cut off, even a small piece of her cheek.
Evgeny Laputin: It seems that a common disadvantage of fillers is their unpredictable behavior after injection. Ideally, an assessment of the recipient capacity of the treated area is necessary. It is quite obvious that any tissue depression has its own volume, the exact correspondence to which will provide the desired result. But, firstly, a methodology for assessing the volume of the recipient area has not been developed, and secondly, the filler, depending on local tissue factors, can either "swell" or "shrink", which cannot but affect the result. Is the statement (paradoxical in its essence) true that the cheaper the drug, the better it is
Example: Biopolymer gel (polymethyl methacrylate) at low cost gives permanent results.
Vladimir Vissarionov: I don't think so. A true manufacturer's product is usually quite expensive due to the high cost of the raw material, the production itself on expensive equipment, the cost of expert work and other costs. Due to numerous fakes, of course, this does not always correspond to reality.
Elena Gubanova: For some drugs, such a statement may be true, but, in my opinion, only under certain conditions: for a patient aged 60 years or more who has undergone plastic surgery, who is aware of long-term risks and ready to share the responsibility with the doctor. We cannot predict what will happen in 5–15 and 20 years. Some EU countries have abandoned the use of polydimethylsiloxanes, having had the unfortunate experience of delayed complications. Many leading plastic surgeons and dermatologists have made their final choice in favor of safer resorbable fillers. I am more impressed by the statement: "there is nothing more permanent than temporary." If aging processes are dynamic, why introduce something permanent? Another statement can be discussed: "Does the price always correspond to the quality?"
Thomas Slater:Many people are very belligerent about the safety of cheap synthetic fillers. Personally, this militancy seems excessive to me. Artificial fillers such as Bioplastiqe, Biphasic, Copolymer, Teflon Paste have been used in the USA for many years. Of course, if the financial possibilities of patients allow, it is better to give preference to biodegradable drugs. In addition, such unpleasant complications of permanent fillers as fragmentation and migration can also occur with the use of Perlane and Dermalife preparations.
Evgeny Laputin: Of course, "Zhiguli" is worse than "Mercedes", but they also go. The same is the case with fillers of artificial origin – the filling effect with their help is quite achievable. Complications and unpleasant side effects are known when using this group of fillers. Therefore, the well-known precautions cannot be neglected. For example, my experience speaks of the complete inadmissibility of applying a biopolymer gel to all areas of the face, with the exception of the lips, where, to my surprise, it is possible to obtain a completely acceptable result in an aesthetic sense. Moreover, when I switched to the tactics of fractional injection of the material (no more than one unit per lip with an interval of at least a month), I completely saved myself and patients from all the described complications, which, in my opinion, is explained by the absence of ischemia of the recipients. areas. It is known from practice that there are three areas of the face that are promising for the use of fillers: lips, nasolabial folds and glabella. At the same time, local skin depressions can also occur in other areas, for example, a pronounced lacrimal trough or involutional depletion of the cheeks. Is it justified and justified to use fillers to correct these problems?
Vladimir Vissarionov: It's hard to say without personal experience. But, having observed a number of, fortunately, few complications after the introduction of polymers into the area of the lacrimal trough, there is no desire to invade this delicate area, since the skin is thin, and all subcutaneous scars are especially pronounced here.
Elena Gubanova: If lipofilling is justified in these areas, then why is the use of fillers not justified? On the contrary, the method of contour plastics is increasingly being used to remodel the face in areas of lipodystrophy. But this is not shown in all cases, so the selection of patients and the implementation of clear manufacturer's recommendations on the technique and injection zones are important. At the very least, major resorbable material companies do not recommend injecting the drug into the tear trough. Since I have little personal experience with the correction of an unexpressed tear trough, I do not yet have a definite answer.
Thomas Slater: In my practice, I strictly adhere to the rule of using fillers for lip remodeling, to fill in nasolabial folds and vertical wrinkles in the glabella area. The use of Restylane Fine Line for the correction of vertical wrinkles of the upper lip and “crow's feet” disappointed both me and my patients, although I saw photos in the brochures with very effective results from the use of this filler.
Evgeniy Laputin: Involutional impoverishment of the middle zone of the face, of course, can be corrected with fillers, but from a financial point of view, this is pretentiousness and a stupid whim, since the cost of the material can exceed several thousand dollars. In addition, I saw a picture of severe subcutaneous deforming fibrosis after applying New-Feel. The subsequent facelift made it possible to visualize the deformed areas: fibrous bands were clearly visible, many of which were located intradermally, which made their removal impossible. Although, it is possible that such a picture was due to technical errors in the administration of the drug. As for the correction of the tear trough, it seems that the usual injection techniques are unsuitable. Recently, other, alternative fillers have been proposed for the correction of these zones, as a rule, in the form of separate grafts.
Is there an algorithm for choosing one or another filler depending on the location and the nature of the problem
Vladimir Vissarionov:Each company, releasing a drug on the market, gives recommendations on its use and implantation technology. However, as a rule, doctors, gaining experience, themselves expand the scope of the filler. In order to develop an algorithm that prescribes the choice of a specific filler for a specific area, it is necessary to have extensive experience with various drugs, and not only positive. It is also important to be able to deal with complications. There is no such algorithm yet, but we are conducting scientific research in this direction.
Elena Gubanova:No, there is no single algorithm. But attempts are being made. Practitioners' discussions show that there are different visions of the same problem, and everyone can be right in their own way, based on their own extensive experience in aging face remodeling. However, as Dr. Vissarionov has already noted, manufacturing companies give clear recommendations regarding indications, contraindications and sequential injection of gels within the same group (for example, possible combinations of different viscosities of hyaluronic acid or collagen-containing gels; do not use them in the same area with permanent implants, etc.). And, apparently, it is reasonable to adhere to these instructions, in order to avoid unwanted phenomena.
Thomas Slater:Master Algorithm – experience of the doctor, his intuition. Another algorithm – some filler should be introduced into the depression zone. It is desirable that there is no overcorrection, and that the drug does not have properties that cause tissue aggression and toxicity.
Evgeny Laputin:It seems that the creation of drug lines with different physical and biological parameters was based on exactly this algorithm. Indeed, the use of drugs such as Restylane, Restylane Fine Line, Perlane, Juviderm (with different viscosity coefficients) has clear target localizations. However, practice shows that this is not always confirmed by stable clinical results. On the contrary, we often see the physician favoring one particular remedy, using different techniques, and getting quite convincing results. It is believed that the use of fillers, especially biodegradable ones, is a non-hazardous procedure, since even in the case of overcorrection, the situation will certainly normalize over time. Is it true?
Are there any other complications, apart from allergic reactions to drugs of protein origin
Vladimir Vissarionov:The more the drug is injected into a particular area, the greater the risk of fibrosis due to ischemia of surrounding tissues and microcirculation disturbances in them. Moreover, this can occur before the completion of biodegradation. In this regard, I like a very old comic expression uttered by Arkady Raikin: "An artist is a person who takes the right paint and puts it in the right place." Only here I would like to involuntarily add: "in the right amount." The most difficult complication that can be conservatively corrected is fibrosis, that is, subcutaneous scars. Moreover, in a number of cases, during a morphological study of the excised excess tissue, the remnants of the implanted material in the scars are not determined.
Elena Gubanova: There is a risk in the use of any fillers, but this is not always associated directly with the drug itself. One of the frequent technical mistakes of novice doctors – overcorrection, which, unfortunately, does not always go away with time. For example, a viscous gel (eg Perlane) introduced superficially into thin skin can deform the area of superficial wrinkles. The biodegradable gel is completely resorbed, but being too long in the superficial layers of the dermis, the "dangerous excess volume" stimulates cell proliferation, which leads to the formation of fibrous cords at the implant site.
Thomas Slater: It has already been said that there is a frivolous attitude towards fillers in society. It was not a wonder (which was repeatedly reported in the media) to hold the so-called botox-parties, where, while drinking champagne to light music, besides Botox, charming ladies inject each other with various fillers. A huge scandal broke out in a number of European countries a few years ago when it turned out that some drugs that were strictly allowed only for professional use (the same Botox, fillers, components for chemical peels) are used in hairdressing salons and baths. It is clear that such places where fillers are used are unlikely to imply the safety of the filling itself.
Evgeny Laputin:Yes, of course, the use of fillers should be considered a safe procedure. If security is understood as a threat to health and life. Experience shows that even preparations based on bovine collagen, despite dire warnings about protein allergic responses, rarely cause any reactions in practice. Danger in another – in an aesthetic aspect. Moreover, it should not be assumed that all the troubles are associated only with the use of artificial materials. Acrylic fibrosis after Dermalife is already considered statistically proven. Personally, in my practice, there was a case when Perlane, used to correct "marionette lines", 2 months after the introduction, fragmented and migrated to the cheek area, What is the local interaction with the sequential use of fillers of different groups for remodeling of one zone
Vladimir Vissarionov
: We can only speculate on the issue of the combined injection of various fillers into one area. We do not have such experience, since we fully adhere to the recommendations of manufacturers to use one material for the correction of one zone. And I don’t want to get complications from the unknown.Elena Gubanova:
No studies have been conducted regarding the interaction of intradermal fillers. Most manufacturers do not recommend the use of resorbable and non-resorbable gels in the same area. However, there are reports of complications in the form of infection and rejection reactions, with the sequential administration of heterogeneous gels.Thomas Slater
: American doctors have been in a better position than their European counterparts for many years, as in the vast majority of cases, preference was given to related drugs (collagen, Zyplast, Resoplast, etc.) . But even in these cases, we have repeatedly noticed a difference in the introduction of the material into the intact tissue and into the area that has undergone fibrosis after previous fillings. In these cases, only with greater caution can the doctor promise an even distribution of the material.Evgeniy Laputin
: The biggest problem, in my opinion, is that it is usually virtually impossible to find out from the patient which drug was used during the previous filling. But at the same time, it is difficult to imagine that the doctor would refuse the procedure with an unclear history. Practice shows that the use of fillers from different groups does not fundamentally change the visual result, although the data of researchers indicate the opposite, which is confirmed by the speeches of other participants in the discussion. Is lipofilling the most natural alternative to commercially produced fillers?Vladimir Vissarionov
: I think not, because the use of fat is associated with the need to borrow it from other areas, and adipose tissue itself is hardly suitable for filling thin skin depressions. Still, it's good to have both.Elena Gubanova: I don't think so. Lipofilling can be more natural, but still a more invasive procedure, although less expensive. But what if there is nowhere to take fat from the patient? To date, there is only one filler registered in Europe, which is recognized by some leading surgeons as an alternative to lipofilling – resorbable gel Restylane SubQ. The drug passed last year clinical trials for safety and efficacy.
Thomas Slater
: It seems that lipofilling is indicated for more courageous and courageous patients, who are actually not so many, because, unlike filling, lipofilling – this is a real operation. However, there are cases (for example, lipodystrophy) when auto-adipose tissue is in every sense the preferred material.Evgeny Laputin
: In my opinion, lipofilling – in all respects the best way to replenish volume and remodel all areas of the face, with the exception of the lips, where adipose tissue transplanted into a non-fat environment simply has to lyse (surprisingly, but in practice this is far from always the case). At the same time, the introduction of lipofilling is progressing rather slowly. And there are two reasons for that. First – as a rule, patients with problems that can be solved with the help of one or another type of filling are not seen by surgeons, but by cosmetologists who do not know surgical techniques.The second reason is that the old modifications of lipofilling have compromised the method itself, and many doctors simply do not take it out of inertia. Although my personal experience shows that with the help of lipofilling it is possible to obtain stable and very effective results, which are completely unattainable with other filling methods.
Evgeny Laputin:
Summarizing my impressions of the discussion, I would like to note that all its participants were free from excessive optimism, once again confirming the relevance of the topic and the absence of simple solutions. The latter I would like to emphasize especially, since underestimation of this often leads to misconceptions about fillers. To understand the biological processes triggered by the filling procedure, serious morphological studies are needed, which are lacking.It may seem that this situation suits doctors who are quite satisfied with the results of the use of fillers. It is doubtful that patients, for whom "rare failures" (according to doctors) turn into real torture, share this position. Psychologically, it is much easier to endure the failure after plastic surgery, which is initially perceived by patients as a risky undertaking, than after a simple and harmless injection.
The main takeaway from this discussion may be a call for clinicians to creatively rethink the filling procedure, consciously abandoning some of the entrenched ideas and taking a closer look at some of the innovations.According to the materials of the journal "Aesthetic Medicine"
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