Publication date: May 11, 2026
Modern medical devices used in plastic surgery and aesthetic medicine now operate within an exceptionally complex regulatory environment. The issue no longer concerns only product safety itself, but above all the boundary between permissible information, advertising, and the legal architecture of digital communication platforms used by manufacturers in the life sciences sector.
Our latest publication and presentation focus on the evolving regulatory framework surrounding the advertising and online communication of PLLA-based biostimulators, aesthetic injectables, and Botox-related products in Europe, including products originating from South Korea and entering the EU market.
We analyze not only advertising restrictions themselves, but also a broader and increasingly important legal issue: how manufacturers should structure and operate digital platforms that simultaneously serve multiple regulatory functions — marketing channels, educational hubs, distributor networks, compliance interfaces, professional information portals, and post-market communication systems.
This creates one of the most sophisticated compliance challenges in today’s healthcare and life sciences sector.
Although the formal user of these products remains the physician, it is ultimately the patient — searching for information online, comparing treatment outcomes, reviewing visuals, and making consumer-driven decisions — who becomes the central subject of regulatory protection under European Union law. This creates a fundamental legal question: where does neutral product information end, and where does advertising begin in a way that may violate patient safety and consumer protection rules?
The publication examines, among other issues:
— restrictions on the online presence of medical device manufacturers,
— legal risks connected with marketing communications concerning products intended exclusively for professional use,
— regulatory concerns surrounding before-and-after photographs, animations, AI-generated materials, and scientific language used in patient-facing communications,
— the legal distinction between informational and promotional content,
— the importance of separating professional-only content from publicly accessible communications,
— the liability exposure of manufacturers and distributors arising from product communication strategies,
— the practical implications of the new Polish and EU advertising framework for the aesthetic medicine and life sciences sectors,
— and, importantly, how online platforms should be architecturally configured from a regulatory perspective, including differentiated access levels, professional zones, patient-facing sections, login-restricted educational materials, and compliance-oriented communication pathways.
The analysis also addresses what such digital platforms should contain under EU medical device law and consumer protection regulations — and equally importantly, what they should avoid. This includes the presentation of scientific materials, treatment visualizations, claims regarding effectiveness, patient safety information, adverse-event communication, and the legal risks connected with hybrid websites combining marketing, operational, and informational functions.
This material demonstrates that medical device law has become one of the key regulatory lenses through which broader questions of technology, patient safety, consumer protection, healthcare quality, platform governance, and corporate responsibility must now be assessed.
Most importantly, the analysis shows a regulatory paradox increasingly visible across the EU: although healthcare professionals are the primary users of these products, the patient occupies the highest position within the hierarchy of legal protection. As a result, manufacturers operating in the life sciences sector must assess communication not merely through the perspective of marketing effectiveness, but through the broader framework of compliance, transparency, and patient safety.
This presentation was prepared and delivered by our team for the American Bar Association International Law Section – Life Sciences and Healthcare Committee on April 29, 2026. During the session, we presented these issues through a highly practical and comparative perspective, using real regulatory examples, case-oriented analysis, and a broader comparison of regulatory systems across Europe.
We intentionally selected this particularly challenging and intellectually engaging legal topic because April and May represent a critical and symbolic period for the ABA International Law Section, coinciding with the organization’s Annual Conference activities. We wanted to contribute — even beyond physical participation at the conference itself — a meaningful substantive contribution to the Committee’s work and to the broader international legal community through an in-depth online presentation and publication platform.
Our intention was to prepare something genuinely distinctive for the Committee: a topic reflecting the evolving intersection of life sciences, medical devices, digital communication, online platform governance, and patient protection within the European regulatory framework.
Advertising of PLLA Biostimulators, Botox and Aesthetic Medical Devices in Europe — Regulatory Boundaries of Digital Platforms, Patient Communication and Online Compliance Architecture
We invite you to read the full article and presentation prepared by our team.
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#PharmaLaw
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Today’s presentation will focus on a topic that may seem highly specialized at first glance, but in practice, it touches on one of the most important regulatory issues in the life sciences sector : the boundary between permitted product information and advertising for products used in aesthetic medicine. Specifically, I’m talking about tissue biostimulants, such as those based on poly -L-lactic acid, hyaluronic acid, calcium hydroxyapatite , or other substances used for tissue stimulation, and comparing them with Botox, or botulinum toxin type A. This comparison is particularly interesting because, from a patient’s perspective, both types of products operate in a similar market segment. They are used in aesthetic medicine practices, are associated with appearance improvement, are administered by injection, and their selection is often preceded by marketing or educational communication addressed to the patient. However, from the perspective of EU and Polish law, these are two distinct regulatory worlds.
The fundamental difference lies in the legal classification of the product. A tissue biostimulant, such as a PLLA-based product, is generally classified as a medical device if its primary intended action is not achieved through pharmacological, immunological, or metabolic means. In other words, the law considers not only where the product is used and what effect it produces from the patient’s perspective, but primarily its mechanism of action. If the primary action is physical, structural, or mechanical in nature, and any potential biological response in the body is secondary to the presence of the material, then the product may fall under the medical device category. Botox, or botulinum toxin, on the other hand, acts through a direct pharmacological mechanism, affecting neuromuscular transmission, and is therefore classified as a medicinal product. This difference in mechanism of action dictates the application of entirely different regulatory principles, a different marketing authorization pathway, and a different scope of permissible market communication. The legal opinion that I analyzed very clearly indicates that the criterion of the principal mode of action is crucial for distinguishing a medical device from a medicinal product, and in the case of PLLA, the effect of collagen stimulation is treated as an indirect effect resulting from the body’s reaction to the material, and not as a direct pharmacological action of the product.
This distinction is fundamental, but it cannot be stopped there. In practice, a tissue biostimulator, although formally a medical device, often has a product life cycle similar to that of a medicinal product used in aesthetic medicine. The product does not reach the patient like a standard product available in a pharmacy or online store. The patient does not simply purchase it and use it independently. In the first phase of the product’s life cycle, its user is a professional, i.e., a doctor or other medically qualified person who selects the product, qualifies the patient, decides on the site of administration, the amount of product, the injection technique, and takes responsibility for the safety of the procedure. Only in the second phase, after leaving the clinic, does the patient become the person responsible for following post-treatment recommendations , monitoring the body’s response, and responding to any adverse reactions. Legal opinions describe this model as a two-stage product life cycle, in which the clinic or medical professional is the user in the first phase, and the patient in the second phase.
It is this duality that causes the greatest legal difficulties. On the one hand, a product is designed and intended for use by a professional. On the other hand, market communication often reaches a patient who is interested in a procedure, searches for information online , compares results, views before and after photos, reads descriptions of the mechanism of action, and based on this, decides whether to visit a specific clinic or ask a doctor about a specific product. As a result, the manufacturer or distributor finds themselves in a situation where they formally communicate about a product intended for professionals, but their message can actually influence consumer and patient decisions. From the perspective of regulatory authorities, this context is crucial. Not only is a single sentence, a single warning, or a single technical description analyzed. The entire communication environment is analyzed, including the website layout, graphics, animations, photos, slogans, the placement of safety information, and whether the recipient might get the impression that the message is directed at them as a potential patient. The legal opinion points out that not only the direct text and visual layer are assessed, but also the context of the entire information medium, which may cause the message to be treated as addressed not only to a professional but also to a layperson, i.e. a future consumer and patient.
In Polish law, this issue has become particularly important following the entry into force of new regulations on the advertising of medical devices. Polish legislators have assumed that advertising medical devices is generally permissible, but subject to significant restrictions. One of the most important restrictions is the prohibition of advertising to the public for products intended for use by users other than laypeople. In practice, this means that if a product can only be safely used by a professional, for example, due to the need for injection, tissue intervention, assessment of the patient’s health, and the risk of complications, advertising such a product to the general public is generally unacceptable. An article prepared by a practitioner aptly points out that most biostimulants require injection and therefore cannot be used by a layperson, but rather by a qualified individual, which directly impacts the admissibility of such advertising.
At this point, it’s important to emphasize a change that’s crucial from the perspective of the Polish market. Procedures involving the administration of tissue biostimulants by injection should be treated as medical procedures, not simply cosmetic treatments. This isn’t just about formal labeling, but also about the nature of the activity. We’re dealing with the introduction of substances into the skin or subcutaneous tissue, with the potential risk of complications, the need to assess contraindications, patient reactions, aseptic technique, and possible management of adverse reactions. Therefore, the safest regulatory approach is to specify that the product should be administered by a physician or dentist with appropriate training in aesthetic procedures. The legal opinion recommends moving away from general terms such as ” licensed” practitioner ” or “ trained healthcare practitioner ,” as these terms may be too vague in the Polish market and may include individuals who do not have the appropriate medical qualifications. Instead, it is recommended to indicate that the product is intended only for use by qualified physicians trained in aesthetic medicine or by physicians with appropriate training in aesthetic procedures.
This is important not only for patient safety but also for the manufacturer’s and distributor’s liability. If a manufacturer communicates a product in a way that is too broad, imprecise, or suggests it can be used by unspecified practitioners, there is a risk that the product will be used by someone without the appropriate qualifications. In this case, the legal risk is not limited to the person performing the procedure. It can also extend to the manufacturer or distributor if it can be argued that the product’s communication was unclear, did not define the appropriate user group, or did not prevent misunderstandings of the product’s intended use. Therefore, from a compliance perspective , it is crucial to indicate in informational and marketing materials that the product is intended for use in a medical environment, by physicians with the appropriate qualifications. The legal opinion even proposes a clause stating that the product is intended primarily for use by qualified physicians who purchase it from authorized distributors and perform the procedure in a medical setting.
Another key issue is the boundary between information and advertising. This is arguably the most important practical issue in communication regarding biostimulants. Medical device law does not provide a single, simple definition of advertising that would automatically resolve all cases. Therefore, each message must be analyzed functionally. Information is neutral, factual, and serves to convey data necessary to understand the product, its intended use, mode of action, risks , and limitations. Advertising, on the other hand, aims to increase sales, promote the product, encourage its selection, or shape a positive attitude. The article indicates that trade catalogs or price lists containing only the trade name, price, or technical specifications are not considered advertising because they lack an element of persuasion. However, the same product description, if placed in a visually appealing context, with claims about rejuvenation, photos of the effects, an animation of the mechanism of action, and a suggestion of exceptional effectiveness, may cease to be neutral information and become advertising.
This distinction is particularly difficult on manufacturer and distributor websites. A medical device website often serves several functions simultaneously. It serves as a source of product information, a contact tool for distributors, a place to distribute materials to professionals, and simultaneously serves as a marketing platform for patients. The legal opinion describes the Olidia website as a hybrid site, combining informational, marketing, and operational functions. This model is typical for the medical device market, but it increases compliance requirements , particularly regarding the separation of communications addressed to professionals and those accessible to patients in general.
A very good example of this problem is the section labeled ” Patient Safety Information.” The name itself suggests information about patient safety, meaning a neutral, regulatory message, perhaps similar in function to instructions for use or risk information. However, the legal opinion indicates that if such information is placed in a banner on the home page, alongside visuals showing before-and-after effects and simplified animations of the mechanism of action, it cannot be treated in isolation as purely neutral information. In this context, it becomes part of a broader marketing communication and is subject to evaluation according to the principles of medical device advertising.
This is a very important practical lesson. Content may be correct in itself, but its context can alter its legal classification. Safety information placed in the instructions for use, in the professional area, or in a calm, technical page layout can be considered information. The same information in a slideshow , alongside images for aesthetic appeal, in simple and persuasive language, can be treated as advertising. Therefore, the boundary between information and advertising is not limited to content. It also extends to the form, location, graphics, audience, function of the message, and the overall impression the website creates for the average patient.
The most important restriction in both EU and Polish law is the prohibition on misleading consumers. In the context of medical devices, this is particularly important because consumers often lack specialized knowledge and can easily attribute properties to a product that it doesn’t possess or expect effects that cannot be guaranteed. The prohibition on misleading consumers extends beyond false claims. It also encompasses omitting important information, creating a false impression about the product’s performance, suggesting uses beyond its intended purpose, and concealing the risks associated with proper use of the product. The article emphasizes that the potential for misleading consumers is sufficient. Even truthful information, if presented in a manipulative, selective, or certain manner, can be problematic.
In aesthetic medicine, images are particularly risky. This applies especially to before-and-after photos, animations, computer simulations, and artificial intelligence-generated materials. These types of materials have a much stronger impact on patients than text. Even if a disclaimer appears next to the image that the effect may vary, the recipient may remember the image above all. Legal opinions indicate that before-and-after visualizations, simplified animations of the mechanism of action, and narrative forms of communication such as testimonials can create unrealistic expectations about the effects of the procedure. Even labeling them as simulations is not always sufficient, as the form and context may lead the patient to perceive them as a realistic representation of the expected effect.
A similar problem applies to the use of scientific language. A manufacturer may want to demonstrate that a product is based on modern technology, that it stimulates collagen, or that it is linked to specific biological processes. The mere use of animation or a simplified diagram is not prohibited. The problem arises when the material gives the impression of greater scientific precision than it actually possesses, or when the patient may be led to believe that the effect is predictable, guaranteed, or the same for everyone. Legal advice recommends, in such cases, adding a clear disclaimer that the visualization is a simplified illustration of the mechanism of action and does not accurately represent biological processes. This is an example of a practical solution that preserves the educational value of the message while reducing the risk of it being perceived as misleading.
Another risk area is scientific publications. In practice, manufacturers often link to scientific articles on PLLA, collagen, skin aging, or biostimulants as categories. From a legal perspective, the mere inclusion of a scientific publication is not prohibited. However, its use can be problematic. If a publication generally concerns poly -L-lactic acid as a category of materials, rather than a specific product, it cannot be presented as evidence of the product’s effectiveness or safety. Legal opinions clearly indicate that such publications should be treated as general scientific background, preferably available in a section intended for professionals, with the appropriate caveat that they do not constitute clinical evidence for a specific product.
At this point, it’s worth returning to the comparison with Botox. In the case of medicinal products, the advertising regime is much more restrictive. A medicinal product, especially one available by prescription or used by a physician, is subject to very strict advertising restrictions directed at the public. Botulinum toxin, as a medicinal product with pharmacological effects, cannot be communicated in the same way as a cosmetic or a typical aesthetic product. However, a biostimulant, as a medical device, operates under a formally more flexible regime. This does not mean, however, that the manufacturer has the freedom to advertise to patients. Flexibility primarily concerns the design of the regulatory regime and the compliance path, but restrictions regarding advertising, recipients, safety, reliability, and the prohibition of misleading consumers remain crucial. The legal opinion aptly emphasizes that classifying a product as a medical device, unlike botulinum toxin as a medicinal product, is associated with a relatively less restrictive regime, but does not relieve the manufacturer of the obligation to maintain high standards of compliance in marketing communications.
From the perspective of Polish practice, it is also crucial that communication with patients should be understandable, but not simplified in a way that distorts the risk. If advertising a medical device is permissible and directed to the public, it should be worded in a way that is understandable to the layperson. However, in the case of products intended for use by professionals, such as injectable biostimulants, the problem is earlier: the question of whether advertising to the public is permissible at all should be asked. Therefore, the communication model should be based not on promoting the product itself to the patient, but on distributing information. The public section can explain general safety issues, intended use, the need for a medical consultation, and the fact that the procedure should be performed by a physician. The professional section, secured by registration or login, can contain more detailed technical materials, instructions, scientific data, training materials, and distribution information.
This is why a professional zone on the website is a positive solution. It doesn’t automatically solve all problems, but it demonstrates that the manufacturer understands the difference between patient and professional. The legal opinion evaluates the dedicated “Professional Zone,” accessible after registration and login, as a solution that mitigates regulatory risks, as it allows for functional separation of communications aimed at the general public from those intended for physicians and distributors.
At the same time, simply creating a professional zone isn’t enough if the public section of the website still contains strong promotional elements. If the homepage features banners, photos of results, slogans about rejuvenation, suggestions for natural skin restoration, scientific animations, and links to publications, the supervisory authority may consider the message to be de facto aimed at patients. In such a case, it should be assessed as communication for the layperson. This means removing or toning down elements that may create unrealistic expectations, and adding clear disclaimers regarding the temporary nature of the effect, individual variability of results, the need for medical consultation, risks , and adverse effects.
A crucial element of communication is the awareness that the treatment’s effects are not permanent and may vary between patients. In aesthetics, patients often seek results, not products per se. If communication focuses solely on improving appearance, skin regeneration, or collagen stimulation, but fails to clarify that the effect is gradual, temporary, and dependent on individual characteristics, there may be a risk of misleading information due to the omission of important information. The legal opinion recommends pointing out that PLLA-based treatments produce gradual and long-lasting, but not permanent, results, and that the duration of the effect may depend on the individual patient’s characteristics and the treatment conditions.
Equally important is the management of adverse events. If a manufacturer lists typical side effects but fails to inform the patient what to do if they occur, communication may be incomplete. From the perspective of patient safety and limiting the manufacturer’s liability, it’s worth adding a simple recommendation that if adverse reactions or unexpected side effects occur, the patient should immediately contact the physician performing the procedure or seek medical advice. Legal advice indicates that such a clause strengthens risk management by encouraging patients to take active steps rather than passively waiting for symptoms to subside.
From the perspective of a manufacturer or distributor in the Polish market, the practical conclusion is as follows: First, the intended use of the product and its user must be precisely defined. Second, communication to professionals must be separated from communication to patients. Third, avoid messages that may suggest guaranteed results, lasting results, therapeutic effects, or a lack of risk. Fourth, remember that the classification of a message as advertising is determined not only by its content but also by its context. Fifth, caution should be exercised when using scientific materials, as publications about substances or product categories do not automatically constitute proof of the effectiveness of a specific product. Sixth, in Poland, it is particularly important to emphasize that injectable biostimulants should be used by physicians with appropriate training, not by cosmetologists or individuals without medical qualifications.
In summary, tissue biostimulants occupy a very interesting regulatory landscape. Formally, they are medical devices, meaning they are not subject to the same restrictive regulations as Botox as a medicinal product. Functionally, however, their method of use, risks, recipients, and communication channels require a very cautious approach. The biggest mistake would be to assume that because a product is not a drug, it can be freely communicated. In reality, precisely because it is an injectable product, used in a medical procedure, yet simultaneously appealing to patients as consumers of aesthetic services, the line between information and advertising must be carefully guarded.
The most important thought I’d like to leave with is this: when it comes to biostimulants, it’s not enough to ask whether a given statement is true. We need to ask who is reading it, in what context they see it, what images accompany it, whether the message encourages choosing the product, whether it creates the expectation of a specific effect, and whether the patient understands that it’s a medical device used in a medical procedure by a doctor. Only the answer to these questions allows us to assess whether we’re dealing with permitted information or advertising that may violate regulations.