TY - JOUR

T1 - Monitoring the safety of medical devices in plastic surgery and cosmetology

AU - Makhova, O.A.

N1 - Export Date: 4 March 2024 Адрес для корреспонденции: Makhova, O.A.; St. Petersburg State UniversityRussian Federation; эл. почта: wishtal@mail.ru Пристатейные ссылки: (2017) PIP breast implant scandal: A story that triggered change, , https://www.massdevice.com/pip-breast-implant-scandal-story-triggered-change, November 13, Accessed June 12, 2023; Informatsionnye pis’ma o meditsinskikh izdeliyakh. Elektronnye servisy, , https://roszdravnadzor.gov.ru/services/unreg, (In Russ). Accessed March 02, 2023; Kim, B, Roth, C, Young, VL, Chung, KC, van Busum, K, Schnyer, C, Mattke, S., Anaplastic large cell lymphoma and breast implants: results from a struc-tured expert consultation process (2011) Plast Reconstr Surg, 128 (3), pp. 629-639. , https://doi.org/10.1097/PRS.0b013e31821f9f23; Medical Device Reports of Breast Im-plant-Associated Anaplastic Large Cell Lymphoma, , https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma, Accessed July 05, 2023; https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources, Accessed July 05, 2023; Manturova, NE, Abdulaev, RT, Ustyugov, AYu., Breast implant-associated an-aplastic large cell lymphoma (2020) Plastic Surgery and Aesthetic Medicine, 2, pp. 5-14. , https://doi.org/10.17116/plast.hirurgia20200215, (In Russ); Collett, DJ, Rakhorst, H, Lennox, P, Magnusson, M, Cooter, R, Deva, AK., Current Risk Estimate of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants (2019) Plast Reconstr Surg, 143, pp. 30S-40S. , https://doi.org/10.1097/PRS.0000000000005567, Mar; (3S A Review of Breast Implant-Associated Anaplastic Large Cell Lym-phoma): PMID: 30817554; Akulin, IM, Makhova, OA, Chesnokova, EA., (2021) Obespechenie bezopasnosti pri primenenii meditsinskikh izdelij, p. 280. , M.: Direkt-Media; Carr, LW, Roberts, J, Potochny, JD., How Breast Implant Surface Type Is In-fluenced by Breast Implant-associated Anaplastic Large Cell Lymphoma: A Survey of the American Society of Plastic Surgeons (2019) Ann Plast Surg, 82 (4), pp. S208-S211. , https://doi.org/10.1097/SAP.0000000000001880, (Suppl 3): PMID: 30855390; (2021) Odin sluchaj na million: vrach o rokovoj protsedure Lindy Evangelisty, , https://peopletalk.ru/article/odin-sluchaj-na-million-vrach-o-rokovoj-protsedure-lindy-evangelisty, September 27, Setevoe izdanie Peopletalk.ru. (In Russ). Accessed March 02, 2023; Manturova, NE, Gladysheva, VV., Paradoxical adipose hyperplasia after cryo-lipolysis (2022) Plastic Surgery and Aesthetic Medicine, 1, pp. 73-78. , https://doi.org/10.17116/plast.hirurgia202201173, (In Russ Engl); Kelly, E, Rodriguez-Feliz, J, Kelly, ME., Paradoxical adipose hyperplasia after cryolipolysis: A report on incidence and common factors identified in 510 patients (2016) Plastic and Reconstructive Surgery, 137 (3), pp. 639e-640e. , https://doi.org/10.1097/01.prs.0000480023.35573.b7

PY - 2024

Y1 - 2024

N2 - 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 s ix 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. © 2024, Media Sphera Publishing Group. All rights reserved.

AB - 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 s ix 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. © 2024, Media Sphera Publishing Group. All rights reserved.

KW - anaplastic large cell lymphoma associated with breast implants

KW - breast implants

KW - cosmetology

KW - cryolipolysis systems

KW - medical devices

KW - monitoring the safety of medical devices

KW - paradoxical fatty hyperplasia

KW - plastic surgery

KW - anaplastic large cell lymphoma associated with breast implants

KW - breast implants

KW - cosmetology

KW - cryolipolysis systems

KW - medical devices

KW - monitoring the safety of medical devices

KW - paradoxical fatty hyperplasia

KW - plastic surgery

UR - https://www.mendeley.com/catalogue/f0715b87-3d53-3267-b818-53870b979ff2/

U2 - 10.17116/plast.hirurgia202401196

DO - 10.17116/plast.hirurgia202401196

M3 - статья

VL - 2024

SP - 96

EP - 102

JO - Plastic Surgery and Aesthetic Medicine

JF - Plastic Surgery and Aesthetic Medicine

SN - 2686-7346

IS - 1

ER -