Regulatory measures when implementing a new medical device into the cosmetic surgery industry. A case example: Macrolane

Abstract

Over the past two decades, the cosmetic surgery industry has experienced significant global growth. This expansion has piqued the interest of healthcare professionals and product manufacturers, both aiming to enhance accessibility to surgery for a broader demographic. This manuscript presents the case example of “macrolane” hyaluronic acid. This product was introduced into the cosmetic surgery industry in 2007 and then removed from the market in 2012 by the manufacturer. The manuscript also presents and discusses the regulatory measures that were enacted following the introduction of macrolane into the European market. Specifically, these regulatory measures involved: insurance, professional qualifications and training, clinician representatives, sanitation, safety, cooling-off periods, informed consent, and advertising. Within the manuscript, it is also highlighted that interests from different stakeholders can create tension in the cosmetic industry, specifically: 1. clients might ask for a product, and they need to be protected; 2. healthcare providers are seeking a profit, and are subject to liability; 3. product’s manufacturers, who are seeking to expand their market, need to pass through regulatory processes. In conclusion, we wish to raise awareness of the ethical issues related to the regulatory measures implemented by European regulatory agencies responsible for public health, especially during the launch of a new product. These ethical considerations encompass several aspects: establishing accountability for validating research authenticity, delineating the functions of compensatory systems, overseeing educational processes, and supervising advertising and marketing practices. It should be noted that the comprehensive exploration of these ethical matters falls outside the scope of this manuscript, as they pertain more to public affairs rather than the realm of cosmetic surgery itself. Therefore, the discourse on these matters is better suited for engagement by experts in political and social ethics. Level of Evidence: Level V, analysis of current regulatory practices.