Objectives: To examine the circumstances of the occurrence of adverse events associated with cryolipolysis and preventative measures.
Introduction: Body shaping treatment methods emphasize fat reduction over muscle gain in our facilities. 14,667 patients used a machine for non-surgical fat reduction treatment from January 2020 to December 2020 in our group. Of those, 9,055 patients used cryolipolisis, making it the most used. Only cryolipolisis device has been approved for the fat reduction by the Ministry of Health, Labor and Welfare of Japan as a medical device. Some of the adverse events associated with cryolipolysis are difficult to treat. The rate of occurrence and reasons for serious adverse events should be considered.
Materials / method: The number of adverse events and their details among patients who received cryolipolysis between January 2020 to December 2020 in our facility was recorded. The data defines cases where patients revisited us in the six-month observation period after the operation and physicians diagnosed as the adverse event associated with cryoliposysis.
Results: Out of the serious adverse events by cryolipolysis, there were two cases of frostbite, one case of hyperpigmentation, one case of bruising, one case of radial nerve paralysis, and one case of Paresthesia. The reasons for the adverse events include four cases due to a lack of understanding or skill of the practitioner, and two cases where the reason was unclear. Out of the six cases, three cases recovered in the six months following the operation, while three cases had lasting symptoms.
Conclusion: Cryolipolysis is generally safe and the rate of severe adverse event is extremely low. However, some adverse events can last more than six months and cannot be prevented. It is necessary to explain the risks related to adverse events to patients before the operation.
Declaraciones
¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No
¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No
¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No
¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No
Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.