TGA Post-Market Review of Energy-Based Devices for Vaginal Rejuvenation

1. Background and Review Initiation

The Therapeutic Goods Administration (TGA) launched a post-market review of energy-based devices (EBDs) promoted for non-surgical vaginal rejuvenation. These devices use technologies such as laser, radiofrequency, or ultrasound to claim benefits including treatment of vaginal laxity, atrophy, stress urinary incontinence, and sexual dysfunction. The review was prompted by emerging safety signals and stakeholder concerns. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation

Key triggers included international regulatory actions, adverse event reports, and questions about the strength of clinical evidence supporting these indications.

2. Devices and Indications Under Review

The review covers energy-based devices (Class IIb and III) included in the Australian Register of Therapeutic Goods (ARTG) and promoted for vaginal rejuvenation. Common technologies include:

• CO₂ lasers
• Erbium:YAG lasers
• Radiofrequency devices
• High-intensity focused ultrasound (HIFU)

Claimed indications often include cosmetic improvement, treatment of genitourinary syndrome of menopause (GSM), vaginal dryness, and mild stress urinary incontinence. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation

Many claims lack robust, long-term clinical data to support safety and effectiveness for these uses.

3. Safety Concerns Identified

The TGA identified several serious risks associated with these devices:

• Thermal burns and tissue damage
• Scarring and fibrosis
• Pain during intercourse (dyspareunia)
• Recurrent or chronic infections
• Worsening of urinary incontinence
• Sexual dysfunction

Adverse events reported include cases requiring surgical intervention. International regulators (e.g., FDA, Health Canada) have issued safety communications highlighting similar concerns. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation

The review noted that many devices were originally intended for other indications (e.g., skin resurfacing) and later promoted off-label for vaginal use.

4. Evidence Requirements and Sponsor Actions

Sponsors of affected devices were required to provide:

• Comprehensive clinical evidence supporting safety and performance for vaginal rejuvenation claims
• Updated risk management files
• Details of post-market surveillance and adverse event monitoring

The TGA assessed whether current evidence substantiates the claims and whether risks are adequately mitigated. Where evidence was insufficient, sponsors faced options including label changes, removal of indications, or ARTG cancellation. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation

Several sponsors voluntarily updated labelling to restrict or remove vaginal rejuvenation claims.

5. Regulatory Outcomes and Recommendations

Key outcomes from the review include:

• Removal or restriction of non-surgical vaginal rejuvenation indications from many device ARTG entries
• Strengthened warnings and contraindications in product information
• Requirement for better consumer and healthcare professional information on risks vs. benefits
• Ongoing monitoring of adverse events related to these devices Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation

The TGA advises consumers and clinicians that non-surgical vaginal rejuvenation procedures lack strong evidence of long-term safety and effectiveness.

6. Consumer and Healthcare Professional Guidance

The TGA recommends:

• Patients consult qualified healthcare professionals and discuss risks/benefits
• Consideration of alternative treatments with stronger evidence (e.g., topical therapies for GSM)
• Reporting of adverse events via the TGA system
• Caution against unsubstantiated marketing claims Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation

Healthcare professionals should ensure informed consent and use devices only for approved indications.

7. Current Status and Ongoing Monitoring

The main phase of the review has concluded with significant changes to ARTG entries and labelling. The TGA continues to monitor safety data and may take further action if new concerns arise. The review underscores the importance of robust post-market surveillance for devices used in sensitive applications. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-energy-based-devices-used-vaginal-rejuvenation

This action reflects the TGA’s commitment to protecting public health by ensuring claims are supported by appropriate evidence.