This report concerns the ultrasound devices used for the aesthetic purposes of body contouring and fat reduction (ablation of adipose tissue). Such devices have recently become more frequent on the Swedish market. These ultrasound devices are currently not medically regulated in Sweden and little is known about their safety and potentially harmful exposure when using them.

This report aims to provide relevant information about present guidelines and scientific results in the area, a survey of the Swedish market and also recommendations on how to characterize the ultrasound emitted by these devices. This information provides an important basis for possible future regulatory actions.

All aesthetic ultrasound devices found on the Swedish market use low-frequency non-thermal ultrasound. These types of devices (with one exception) have not yet been studied in peer-reviewed publications and the technical specifications from the suppliers are often incomplete. Consequently, there is a need to evaluate the devices in order to gain adequate knowledge about possible risks associated with their use.

Ultrasound exposure should be characterized by its frequency and acoustic pressure. It has not been fully investigated whether the mathematical equation for the mechanical index is valid for the low frequencies used by aesthetic ultrasound equipment on the Swedish market. In this report, two different hydrophone measurement set-ups for characterization of ultrasound exposure are proposed. The most common reason behind adverse events or exposure of non-target tissue regions is most likely handling errors by the operator. Hence, only characterization of the ultrasound field does not necessarily imply the safe use of aesthetic ultrasound devices.

It is recommended that the Swedish Radiation Safety Authority and the Swedish Medical Products Agency discuss their respective future responsibility and how aesthetic ultrasound devices should be regulated.