Stephanie McLean ABIC’s Stef Milla tells us what’s changing.
The Therapeutic Goods Administration (TGA) has completed a post-market review of energy-based devices for vaginal rejuvenation, concluding that “insufficient clinical evidence supports their therapeutic use and long-term safety.” As a result, all such devices have been removed from the market. This decision represents a significant turning point for the Australian aesthetic industry, sparking conversations among practitioners and stakeholders.
Overview of the TGA’s Review
The review focused on devices using radiofrequency (RF), carbon dioxide (CO2), or Er:YAG (erbium-doped yttrium aluminium garnet) lasers marketed for vaginal rejuvenation. These devices claimed to address various gynaecological and aesthetic conditions, including vaginal laxity, stress urinary incontinence, and sexual dysfunction.
As stated by the TGA, due to a lack of clinical evidence supporting their therapeutic use and long-term safety, these devices have now been removed from the Australian Register of Therapeutic Goods (ARTG).
This decision follows similar global actions, including the U.S. FDA’s 2018 statement expressing “serious concerns about the use of these devices to treat gynaecological conditions beyond those for which the devices have been approved or cleared.”
A Landscape in Flux
While these devices remain approved for other uses—such as dermatological treatments—their application for vaginal rejuvenation has been banned. According to the TGA, the risks of these procedures, which may include scarring, infection, or permanent changes to sexual sensation, outweighed the benefits in the absence of strong clinical backing.
In 2022, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) stated, “At present, there is no evidence that these procedures are effective, enhance sexual function or improve self-image. The risks of potential complications such as scarring, adhesions, permanent disfigurement, infection, dyspareunia, and altered sexual sensations should be discussed in detail with women seeking such treatments.”
Despite these findings, some practitioners state that anecdotal patient feedback often highlights improvements in quality of life, including symptoms of relief and increased self-confidence. However, the TGA emphasises that regulatory decisions must rely on robust clinical evidence rather than subjective reports.
The Review Process
The TGA’s review assessed evidence provided by sponsors and manufacturers, expert advice, and published literature. Each regulatory decision was made on an individual basis, with some devices voluntarily withdrawn by sponsors, while others were cancelled by the TGA.
It is important to note that not all energy-based devices have been removed from the market. Devices used for dermatological and other non-gynaecological applications remain approved, provided their ARTG entries exclude vaginal rejuvenation claims.
For further details on specific ARTG entries and impacted devices, stakeholders are encouraged to visit the TGA website.
Seeking Industry Feedback
The TGA is inviting comments from professionals to ensure all perspectives are considered in the ongoing regulation of these devices and considers it important that stakeholders engage with this process. As the peak body for the beauty and aesthetic industry, the Aesthetic and Beauty Industry Council (ABIC) is working to gather feedback from industry stakeholders as part of our self-regulatory committee.
Implications for Practitioners and Patients
With no approved devices currently available for vaginal rejuvenation, practitioners must again navigate a new regulatory landscape. Healthcare professionals are encouraged to discuss alternative treatment options with their patients while providing balanced advice on the risks and benefits of available therapies.
The TGA advises consumers to consult qualified healthcare professionals for guidance on managing gynaecological conditions. Any adverse effects or complications arising from previous treatments should be reported to the TGA via the Incident Reporting and Investigation Scheme (IRIS).
Participation is Simple
This development underscores the importance of collaborative regulation within the beauty and aesthetic sector. Head over to https://theabic.org.au/abic-self-regulation-committee to collaborate with a peak industry body that works with regulatory bodies like the TGA to advocate for sustainable growth, elevated standards and play an active role in advancing the industry.
Moving Forward
The removal of energy-based vaginal rejuvenation devices underscores the ongoing evolution of safety and efficacy standards in the aesthetic industry. While this decision has sparked a diverse range of reactions, it also serves as a reminder of the critical role regulatory feedback and evidence-based practice play in maintaining public trust. The government respects numbers and together the industry can remain engaged in shaping a regulatory environment that supports innovation while prioritising patient safety.
For more information on the TGA’s decision and how to provide feedback, visit the official TGA website: https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation.
