ThermiVA
ThermiVa is a non-ablative radiofrequency device applied to the vaginal and vulvar tissue. It is important to understand its regulatory status before considering it: ThermiVa is FDA-cleared for electrocoagulation and haemostasis in dermatologic and general surgical procedures. The FDA has not cleared any energy-based device for vaginal "rejuvenation," cosmetic vaginal procedures, or the treatment of urinary incontinence, sexual function or menopause-related symptoms. Use for those purposes is off-label. Treatment is a series of four sessions at $4,230, with maintenance at $1,175.
What the FDA has said
We set this out first because most pages on this subject do not, and you are entitled to it before anything else.
In July 2018 the FDA issued a safety communication warning patients and providers that energy-based devices used for vaginal "rejuvenation," cosmetic vaginal procedures, or to treat symptoms related to menopause, urinary incontinence or sexual function may be associated with serious adverse events. Reported complications included vaginal burns, scarring, pain during intercourse, and recurring or chronic pain.
The FDA stated it has not cleared or approved any energy-based device for these indications.
Alongside the safety communication, the FDA wrote to seven manufacturers of energy-based devices marketed for these purposes, asking them to substantiate their claims. ThermiVa’s manufacturer was one of the seven, along with the makers of MonaLisa Touch, diVa, FormaV and others. The agency subsequently notified ThermiVa’s manufacturer that its inquiry was closed.
What this means in practice:
- The device itself is FDA-cleared, but for electrocoagulation and haemostasis in dermatologic and general surgical procedures — not for the uses it is commonly marketed for.
- Using it for vaginal or vulvar concerns is an off-label application. Off-label use is legal and common in medicine, but it means the device has not been reviewed and cleared by the FDA for that specific purpose.
- Claims you may encounter elsewhere about tightening, improved sexual function, or resolution of incontinence are not FDA-reviewed claims, and we will not make them here.
If you have been told otherwise by another practice, that is worth weighing.
Ablative laser vs. non-ablative radiofrequency — an important distinction
The FDA communication addressed energy-based devices as a category, and did not attribute specific adverse events to specific devices. But the devices in that category are not equivalent, and the difference is worth understanding.
| Ablative fractional laser | Non-ablative radiofrequency | |
|---|---|---|
| Examples | MonaLisa Touch, diVa | ThermiVa |
| What it does to tissue | Vaporises microscopic columns of tissue, creating controlled wounds that must heal | Heats tissue without removing or vaporising it; the surface stays intact |
| Temperature control | Depth and thermal effect set by laser parameters | Continuous temperature monitoring intended to hold tissue within a set range |
| Plausible mechanism for burns and scarring | Yes — ablation creates a wound, and excessive depth or energy can injure | Substantially lower — no tissue is removed and there is no wound to heal |
What follows from this, stated carefully:
- The severe events described in the FDA communication — burns, scarring, chronic pain — are mechanistically far more plausible with ablative laser treatment than with temperature-monitored non-ablative radiofrequency.
- However, the FDA did not exempt radiofrequency devices, and ThermiVa’s manufacturer was among those it wrote to. Any practice telling you the FDA action did not concern ThermiVa is mistaken.
- The absence of FDA clearance for these indications applies to both modalities equally. Off-label is off-label, whether ablative or not.
We draw this distinction because it is true and useful, not to suggest the regulatory position is different than it is.
What is ThermiVa?
ThermiVa uses non-ablative radiofrequency — the same category of energy used in Thermage for the skin. A small curved handpiece applies controlled radiofrequency energy to the tissue, with temperature monitoring intended to keep it within a set range.
As with radiofrequency applied elsewhere in the body, the intent is to heat tissue enough to affect collagen. It is non-surgical, requires no anaesthesia, and does not involve cutting.
What is the evidence?
The honest position is that the evidence base is limited.
Published studies in this area are generally small, frequently lack control groups, and often rely on patient-reported questionnaires rather than objective measurement. Some report symptomatic improvement; the FDA's position reflects that this body of evidence has not been sufficient to support clearance for these indications.
The American Urogynecologic Society has issued a clinical consensus statement on vaginal energy-based devices, and its guidance likewise reflects that evidence remains limited and that patients should be counselled accordingly.
We would rather tell you the evidence is thin than imply it is settled. Some patients report benefit. Whether that reflects the treatment, natural variation, or expectation is not something the current evidence can separate reliably.
What are the risks?
Per the FDA safety communication, reported adverse events across all energy-based vaginal devices — ablative and non-ablative together — include:
- Vaginal burns
- Scarring
- Pain during sexual intercourse (dyspareunia)
- Recurring or chronic pain
As set out above, these severe events are mechanistically more plausible with ablative laser devices, which vaporise tissue, than with non-ablative radiofrequency, which does not. The FDA did not break its reports down by device or modality, so the relative rates are not publicly established.
What is more commonly reported with non-ablative radiofrequency is temporary discomfort, mild swelling and transient irritation.
Because the device is not cleared for these uses, there is no FDA-reviewed safety dataset specific to them — which is itself a meaningful part of the risk picture.
What is the treatment like?
A small handpiece is applied externally and internally over roughly 30 minutes per session. No anaesthesia is used and the sensation is described as warmth. There is no downtime, and normal activity including intercourse can generally resume the same day.
The standard course is a series of four sessions, typically about a month apart, with maintenance sessions thereafter.
What does it cost?
| Price | |
|---|---|
| Series of 4 treatments | $4,230 |
| Maintenance treatment | $1,175 |
Not covered by insurance. A $500 non-refundable deposit is required for treatments of $1,000 or more. Packages expire three years from purchase.
Full non-surgical pricing · Financing
Before you consider this treatment
See a gynaecologist or urogynaecologist first. This is our genuine recommendation, not a formality.
The symptoms that lead people to look at ThermiVa — urinary leakage, vaginal dryness, discomfort with intercourse, laxity after childbirth — have identifiable medical causes, and several have treatments with far stronger evidence and, frequently, insurance coverage:
- Stress urinary incontinence — pelvic floor physical therapy has good evidence and is often covered. Surgical options exist with substantial evidence behind them.
- Genitourinary syndrome of menopause (dryness, irritation, painful intercourse) — topical vaginal oestrogen is well studied, effective for most women, and inexpensive.
- Pelvic organ prolapse — requires proper assessment; energy treatment is not a treatment for prolapse.
- Pain with intercourse — has multiple possible causes that warrant diagnosis before any treatment.
An energy device is not a substitute for a diagnosis. If you have not had these symptoms properly evaluated, that is the first step — and if a cheaper, better-evidenced, possibly covered treatment addresses your problem, you should know that before spending $4,230.
Who should not have this treatment?
- Anyone who has not had their symptoms medically evaluated.
- Pregnancy.
- An implanted electrical device such as a pacemaker or defibrillator — radiofrequency is contraindicated.
- Metal implants in the treatment area, including an IUD in some circumstances — disclose it.
- Active infection, including urinary tract or vaginal infection.
- Undiagnosed vaginal bleeding. This needs investigation, not treatment.
- Pelvic organ prolapse requiring proper management.
- A history of pelvic radiation or vulvar skin conditions such as lichen sclerosus, without specialist input.
- Anyone uncomfortable with an off-label use of a device supported by limited evidence. That is an entirely reasonable position.
Frequently asked questions
Is ThermiVa FDA-approved?
ThermiVa is FDA-cleared for electrocoagulation and haemostasis in dermatologic and general surgical procedures. The FDA has not cleared it, or any energy-based device, for vaginal rejuvenation, cosmetic vaginal procedures, or for treating urinary incontinence, sexual function or menopause-related symptoms. Use for those purposes is off-label.
What did the FDA warn about?
In July 2018 the FDA issued a safety communication about energy-based devices used for these purposes, citing reports of vaginal burns, scarring, pain during intercourse, and chronic pain, and stating no such device had been cleared for these indications.
Does ThermiVa work?
The evidence is limited. Published studies are generally small, often uncontrolled, and rely largely on self-reported outcomes. Some patients report improvement. We will not tell you it is proven, because it is not.
How much does ThermiVa cost?
$4,230 for a series of four treatments, and $1,175 per maintenance treatment. Not covered by insurance.
How many treatments are needed?
The standard course is four, roughly a month apart, followed by periodic maintenance.
Does it hurt, and is there downtime?
Most patients describe warmth rather than pain, and there is no downtime. Each session takes about 30 minutes.
Should I try something else first?
Very likely, yes. Pelvic floor physical therapy for incontinence and topical vaginal oestrogen for menopausal symptoms both have substantially stronger evidence, cost far less, and are frequently covered by insurance. Get a diagnosis before considering an energy device.
Can I have ThermiVa with a pacemaker?
No. Radiofrequency is contraindicated with implanted electrical devices.
Next steps
If you are considering this treatment, we would rather have a frank conversation about what is and is not known than sell you a package. That conversation will include the regulatory position set out above, the limits of the evidence, and whether a better-established treatment might address your symptoms first.
Naficy Rejuvenation Center is located in Bellevue, Washington, and serves patients from Seattle, the Eastside, and throughout the Pacific Northwest.
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This page is provided for information and is not medical advice. Symptoms affecting urinary, sexual or gynaecological health should be evaluated by a physician. Medically reviewed by Sam Naficy, MD, FACS, board-certified by the American Board of Facial Plastic and Reconstructive Surgery.
