OBJECTIVE
To study the responsibilities of plastic surgery and cosmetology clinics in monitoring the safety of medical devices, available data on safety of medical devices in cosmetology and plastic surgery, as well as availability of these data for a wide range of users.
MATERIAL AND METHODS
We estimated the basic principles of monitoring the safety of medical devices and requirements for medical organizations. We analyzed data by Roszdravnadzor regarding safety of medical devices in plastic surgery and cosmetology. Safety of certain breast implants and cryotherapy systems was reviewed.
RESULTS
The modern system for monitoring the safety of medical devices increased the role and improved interaction of all participants. Medical organizations are the main source of information on safety of medical devices. In addition to sending reports to Roszdravnadzor, clinics should inform the manufacturer (its authorized representative) about adverse event and, if necessary, provide access to medical device for safety monitoring participants. In addition, medical organizations are obliged to carry out the activities listed in the information letters from Roszdravnadzor. For this purpose, the head of the medical organization appoints an official responsible for monitoring the safety of medical devices. The Roszdravnadzor published letters on safety of six medical products specific to cosmetology and plastic surgery between 2018 and 2022 (breast implants, tissue expanders, cryotherapy system, intradermal gel implant). There were one report about new data on safety and five reports on medical device recall. Analysis of safety of certain breast implants and cryotherapy systems shows that issue of their safe use is quite acute. Researches of effects of these medical devices on adverse reactions are ongoing. Physicians and patients in developed countries are informed about association of adverse events with these medical devices. Available data in the Internet published by regulators and professional societies of medical specialists are essential. At the same time, information provided by manufacturers is extremely insufficient. Apart from official letters from Roszdravnadzor, there are almost no data for users in Russian, with the exception of individual scientific publications.
CONCLUSION
Problems associated with safety of some medical devices specific to cosmetology and plastic surgery (for example, breast implants, cryolipolysis devices) are acute and actively studied. Plastic surgery and cosmetology clinics need to strengthen internal control for safe care, send information about incidents to Roszdravnadzor and control the information about decisions made by Roszdravnadzor for monitoring the safety of medical devices. Informing by medical device manufacturers and professional non-profit organizations is extremely necessary. It should improve patient safety and strengthen their confidence in aesthetic interventions.
