Post-market review of energy-based devices used for vaginal rejuvenation

The TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG). The review found there was insufficient clinical evidence to support the therapeutic use and long-term safety of these devices.

All energy-based devices intended to be used for vaginal rejuvenation sold in Australia have now been cancelled from the ARTG by the TGA or the sponsor.

Information for consumers and healthcare professionals

Consumers and healthcare professionals should be aware that there are currently no devices included in the ARTG that are approved for use for vaginal rejuvenation.

Consumers are encouraged to seek advice from a healthcare professional on the range of options for care and management of genitourinary conditions.

The Australasian Menopause Society (AMS - external site), Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG - external site) and National Institute for Health and Care Excellence (NICE - external site) have published guidance on management options for genitourinary conditions and alternatives to laser therapy.

RANZCOG has also published a best practice statement on the Use of Lasers in Obstetrics and Gynaecology - external site.

Healthcare professionals are expected to provide unbiased advice on the risks and benefits of devices and medical treatments, based on current scientific evidence and the individual medical profile of each patient.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

Energy-based vaginal rejuvenation devices

The term ‘vaginal rejuvenation’ includes a range of aesthetic and functional procedures that claim to correct and restore the structure of the vagina and surrounding tissues. The claims include improving sexual function, and/or claiming to improve the appearance of the female genitalia.

‘Energy-based’ means these devices use laser energy to achieve their intended purpose, and include radiofrequency (RF), carbon dioxide (CO₂), or Er:YAG (erbium-doped yttrium aluminium garnet) lasers.

These laser energy devices can have broad purposes distinct from use in vaginal rejuvenation, including for use in dermatology and other specialties, but in recent times they have been marketed as treatment for a number of conditions, including but not limited to:

• vaginal laxity (looseness) post childbirth
• stress urinary incontinence (SUI) / leakage
• sexual dysfunction
• labia minora/majora hypertrophy (increased size of the labia)
• vulvovaginal atrophy (VVA) – thinning, drying, and inflammation of the vaginal walls
• genitourinary syndrome of menopause (GSM) and associated symptoms of dryness, itching and dyspareunia (pain).

Background of the review

We have received signals and identified concerns in relation to the use of energy-based devices for vaginal rejuvenation.

The US Food & Drug Administration published a statement - external site in July 2018, on the risks related to devices marketed for vaginal rejuvenation, and that the FDA ‘has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared’.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG - external site) published a statement, that ‘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’.

In response to these signals, the TGA has undertaken a post-market review of energy-based devices for the purpose of vaginal rejuvenation that use radiofrequency (RF), carbon dioxide (CO₂), or Er:YAG (erbium-doped yttrium aluminium garnet) lasers.

The purpose of the review was to assess the safety and performance of the devices, including reviewing clinical evidence to support the use of the devices for vaginal rejuvenation, and to ensure devices included in the ARTG continue to meet the essential principles (EPs) set out in the Therapeutic Goods (Medical Devices) Regulations 2002.

Post-market review: overview

As part of inclusion in the ARTG, sponsors and manufacturers of medical devices have a range of post-market obligations. This includes maintaining evidence that demonstrates devices continue to be safe and perform as intended, and providing this evidence to the TGA when requested.

Throughout the review, the TGA considered a range of information to ensure all regulatory decisions are evidence-based. This included seeking expert advice on risks and benefits relating to these devices, and looking at published literature and data held by sponsors and manufacturers for their device.

The TGA considered clinical guidance and statements including those from RANZCOG - external site and NICE - external site, and sought expert advice from the Advisory Committee on Medical Devices (ACMD) relating to risks and benefits of these devices. The advice provided by the ACMD reflected the published guidance for management of genitourinary symptoms, that laser therapy is not the gold standard treatment for these symptoms, and that there is a lack of clinical evidence demonstrating performance and long-term safety for these devices.

Post-market review: outcomes and actions

Following review of evidence provided by sponsors and manufacturers, all energy-based devices intended for the use of vaginal rejuvenation sold in Australia have been cancelled.

Some devices were cancelled by the sponsors, and the TGA cancelled all other devices included in the review. The review found there was insufficient clinical evidence to support the intended use and long-term safety of these devices.

All regulatory decisions made during this review were made on an individual basis. All decisions were based on the evidence submitted by sponsors, expert advice, and literature.

Some ARTG entries include a range of different devices and handpieces used for different purposes including dermatology and other specialties. Where multiple devices were supplied under one ARTG entry, we have only cancelled the devices that are intended for the use of vaginal rejuvenation. The devices used for other applications can continue to be used.

Information for providers

Providers should be aware that there are currently no devices included in the ARTG that are approved for use for vaginal rejuvenation.

If you are unsure if your cosmetic device is a medical device and requires ARTG inclusion you can refer to our guidance and contact your supplier.

Outcome by ARTG entry

The table below has the status of all ARTG entries included in the review.

Note: An ARTG entry may be cancelled in two ways: (1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or (2) the TGA may cancel the entry. The sponsor can cancel their entry at any time and is not required to provide a reason to the TGA.

Similarly, if an ARTG entry has other uses outside of vaginal rejuvenation, the use specifically for vaginal rejuvenation purposes can be cancelled in two ways: (1) the sponsor may voluntarily withdraw claims for use in vaginal rejuvenation or (2) the TGA may cancel the entry for vaginal rejuvenation, however the ARTG entry remains active for its other uses.

Reporting problems

The TGA strongly encourages consumers and healthcare professionals to closely monitor for patient symptoms and to immediately report any complication and/or side effects from laser therapies for vaginal rejuvenation.

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).