01Regulatory update · Therapeutic Goods Administration
TGA review —
energy-based devices for vaginal rejuvenation.
In November 2024, the Therapeutic Goods Administration completed a post-market review of energy-based devices used for vaginal rejuvenation in Australia. The review concluded that the entries on the Australian Register of Therapeutic Goods for these specific applications would be cancelled, on the basis of safety and performance evidence.
02What was reviewed
Devices reviewed —
and what was decided.
The review covered energy-based devices including radiofrequency, carbon dioxide and Er:YAG laser systems that had been marketed for use in vaginal rejuvenation. The TGA's regulatory decisions were made device by device, on the evidence submitted by sponsors, advice from clinical experts, and the published literature.
Where a device had a single Australian Register of Therapeutic Goods entry covering several applications — for example dermatological as well as gynaecological uses — only the vaginal rejuvenation indication was cancelled. Devices used for other purposes can continue to be supplied for those purposes.
More on the potential risks of cosmetic procedures is available on our risks page.
— Dr Kishen Nara, RevAesthetic.
03What they were advertised for
A long list —
of claims.
Energy-based devices for vaginal rejuvenation had been advertised across a wide range of conditions. The list below is drawn from the TGA's review documents.
- 01Vaginal laxity following childbirth.
- 02Stress urinary incontinence (leakage of urine on coughing, laughing or exercise).
- 03Sexual dysfunction.
- 04Hypertrophy of the labia minora or labia majora (an increase in size).
- 05Vulvovaginal atrophy — thinning, drying or inflammation of the vaginal walls.
- 06Genitourinary syndrome of menopause and associated symptoms such as dryness, itching and pain with intercourse.
04What patients should know
The review's outcome —
and the conversation.
For a patient who has been considering one of these devices, the practical question is what to do next. The TGA encourages patients to ask their treating doctor about energy-based devices used in vaginal rejuvenation, and to expect an unbiased explanation of the relevant adverse events and their personal medical context.
The TGA's decision
- Energy-based devices intended for vaginal rejuvenation have been cancelled from the ARTG.
- Where a device entry covered multiple uses, only the vaginal rejuvenation indication was cancelled.
- Decisions were based on the evidence submitted by sponsors, expert advice and the literature.
- Devices used for other indications, where supported by evidence, may continue to be supplied for those indications.
Considerations during a consultation
- Take time. There is no clinical reason to make a decision in a single visit.
- Conservative options first — pelvic floor physiotherapy, hormonal treatments where appropriate, and watchful waiting are reasonable starting points.
- Psychological assessment is part of the consultation, not an optional add-on.
- Each person's anatomy is unique — the labia minora, majora, mons pubis and clitoral hood vary widely, and this matters when discussing options.
- Labiaplasty is specific surgery with specific limitations. It can alter shape and form. It cannot do everything an energy-based device was once advertised to do.
05Conservative options
Conservative care —
is also care.
A consultation about vaginal rejuvenation is also a conversation about not treating, or about treating conservatively. For some patients, pelvic floor physiotherapy, lubricants, hormonal options where appropriate, or simply more time and information are the right next steps. Doing nothing is a legitimate clinical option that should not require justification.
Some patients, after time, will consider labiaplasty. Labiaplasty is specific surgery — it can alter shape and form, and there is more about it on our labiaplasty page. It is not a like-for-like substitute for what energy-based devices had been advertised to do, and a careful consultation will make that explicit.
06About the practitioner
Dr Kishen
Nara.
Dr Kishen Nara is a registered medical practitioner. He sees patients across Melbourne, Tasmania and Adelaide. The team at RevAesthetic includes practice manager Cate, Patient Liaison Jenny, and registered nurses, all involved in supporting your enquiry.
All assessments are conducted in line with Medical Board of Australia guidelines. A second medical opinion is encouraged at any stage.
- MBBSBachelor of Medicine, Bachelor of Surgery — Monash University
- FACCSM(Surg)Surgical Fellow, Australasian College of Cosmetic Surgery and Medicine
- AHPRARegistered medical practitioner — General Registration MED0001201549
07Enquire
Begin a
conversation.
Consultations are conducted personally by Dr Nara across Melbourne, Tasmania and Adelaide. We respond within one business day. There is a written reflection period before any decision, and a second medical opinion is encouraged at any stage.
08Continue reading
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the journal.
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Disclaimer: This article is a plain-language summary of the Therapeutic Goods Administration's post-market review. The official TGA documents remain the authoritative source. All cosmetic procedures, including labiaplasty, carry inherent potential risks and complications. We encourage you to seek a second opinion from a qualified medical professional before any procedure.