| Reason for the Action |
The TGA undertook a post-market review of all energy-based devices used for vaginal procedures included in the ARTG. This review was prompted by an FDA safety notice as well as enquiries received by the TGA related to this notice. The TGA has also noted that they have received signals and identified concerns in relation to the use of energy-based devices for the treatment of vaginal rejuvenation, vaginal laxity, vaginal atrophy, menopausal symptoms, or urinary
incontinence.
The ARTG’s have been cancelled by Gaysons, due to the inability to provide current information from the manufacture. Therefore, there is insufficient evidence to support the safe use in vaginal procedures as per the ARTG’s intended use. Due to this the devices are to be removed from the market. |