Vaginal "Rejuvenation" and Tightening Treatments: What the FDA Warned and What a Sham Trial Found

“Vaginal rejuvenation” packages promise tighter tissue, less dryness, fewer leaks and better sex, usually with a laser or radiofrequency wand and a price tag in the thousands. Here is what regulators and researchers found.

What the FDA said

In July 2018, the FDA¹ warned patients and clinicians about using energy-based devices, such as lasers and radiofrequency, for vaginal “rejuvenation” or cosmetic vaginal procedures.¹ It called “rejuvenation” an ill-defined term used for treatments aimed at:¹

• vaginal looseness
• dryness, itching or thinning after menopause
• pain during sex or urination
• decreased sexual sensation

The FDA¹ said it had not cleared or approved any energy-based device to treat these symptoms or any symptoms related to menopause, urinary incontinence or sexual function. It warned of serious problems, including vaginal burns, scarring, pain during sex and long-lasting pain.¹ It also said some manufacturers had been marketing devices for these unapproved uses.¹

What a sham-controlled trial found

In a 2021 Australian trial, 85 postmenopausal women with vaginal symptoms (average age 57) received three sessions of either a fractional CO2 laser or a sham treatment that looked the same. Neither the women nor the assessors knew who got which.²

After 12 months, there was no significant difference between laser and sham in symptom severity, quality of life, vaginal health scores or tissue samples.² No severe side effects were reported in either group.²

That’s a key point: in open studies without a sham group, improvement can come from expectation. When the comparison was fair, the laser didn’t come out ahead. Our article on evidence checks before vaginal laser treatment covers the wider research.

Options with stronger evidence

• Dryness or pain with sex: vaginal moisturizers and lubricants and vaginal estrogen.
• Leaks: pelvic floor exercises and devices or procedures your clinician can explain.
• Looseness or a bulge: ask to be checked for prolapse.

Before you book

1. Ask what device will be used and what the FDA¹ has cleared it for.
2. Ask for the evidence, specifically studies with a sham comparison.
3. Ask about burns, scarring and pain, and who handles complications.¹
4. Get a pelvic exam first to diagnose what’s causing your symptoms.
5. Report problems through the FDA’s¹ MedWatch program.¹

Try: “A spa offered me a vaginal tightening laser package. What’s causing my symptoms, and what treatments have been shown to work for them?”

Down There, Decoded includes a Down-There Log and a See script for appointments. Use them to describe your symptoms clearly and ask about tested treatments. Explore the intimate-health playbook.