Genital Rejuvenation

What is Genital Rejuvenation?

Genital rejuvenation is not the name of a single medical procedure. It is an umbrella term with no medical definition, used to group together procedures for the female external genitalia and the vagina that differ widely in their aims and methods. The name alone does not tell you which area is treated, with which method or for which complaint.

The term comes from marketing language. The Society of Obstetricians and Gynaecologists of Canada (SOGC) states that phrases such as ‘vaginal rejuvenation’ should be regarded as marketing terms with no medical origin, and that for this reason they cannot be assessed scientifically. The American College of Obstetricians and Gynecologists (ACOG) refers to the name as a ‘so-called’ label, and the US Food and Drug Administration (FDA) regards the term as poorly defined.

According to the FDA, the name is sometimes used for non-surgical procedures aimed at complaints such as vaginal laxity, vaginal atrophy (thinning of the vaginal tissue), dryness or itching, pain during sex (dyspareunia), pain when passing urine and reduced sexual sensation. Most of these complaints are gynaecological rather than cosmetic problems, and each needs a medical assessment in its own right.

According to a review that brings together studies on cosmetic gynaecology, there is no generally accepted terminology in this field. The procedures mentioned under this heading include reducing the inner labia (labia minora), plumping the outer labia (labia majora), surgically narrowing the vagina, reducing or lifting the area above the pubic bone (mons pubis), and energy-based treatments for laxity.

This page covers only non-surgical options: energy-based devices such as laser and radiofrequency, hyaluronic acid injections into the outer labia, and platelet-rich plasma (PRP) injections. The name ‘rejuvenation’ is used here because it is the term people most often search for; it does not describe a result, and it is not a measure showing that any tissue has returned to its former state.

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Energy-based devices and the FDA warning

The FDA has stated that ‘vaginal rejuvenation’ procedures using energy-based devices such as laser and radiofrequency, and non-surgical vaginal procedures for symptoms related to menopause, urinary incontinence or sexual function, have not been proven safe and effective.

According to the FDA’s Safety Communication of 30 July 2018, these devices have been cleared for marketing for general gynaecological uses, such as destroying abnormal or pre-cancerous tissue in the cervix or vagina and removing genital warts. However, the FDA has not cleared or approved any energy-based device for ‘vaginal rejuvenation’, cosmetic vaginal procedures, or the treatment of symptoms related to menopause, urinary incontinence or sexual function. The communication also points out that some manufacturers may be promoting their devices for these purposes.

According to the communication, these treatments can cause serious adverse events such as vaginal burns, scarring, pain during sex, and recurring or chronic pain. The FDA recommends that you discuss the benefits and risks of all available treatment options for your vaginal complaints with your doctor.

Professional bodies are also cautious. The American Urogynecologic Society issued a consensus statement on vaginal energy-based devices (a document reflecting the shared view of experts). Of the 40 statements assessed, consensus was reached on 28 and not reached on 12; one of the main reasons for this was a lack of evidence. According to the North American Menopause Society, there are not enough placebo-controlled studies (studies comparing the treatment with an inactive one) to draw conclusions or make recommendations about the effectiveness and safety of energy-based treatments, including laser.

Energy-based devices are described here not because they are a treatment offered at this clinic, but because they are the group of methods most often mentioned under the heading of ‘genital rejuvenation’. If you are going to make a decision about this, you need to know about the FDA warning and what controlled studies have found.

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Menopause-related dryness and pain during sex

Vaginal dryness, burning and pain during sex that appear with the menopause are not a matter of rejuvenation. Together they form a medical condition known as genitourinary syndrome of menopause (GSM), which needs a gynaecological assessment first. In controlled studies, vaginal laser has not been shown to be consistently more effective for this condition than a sham treatment (a mock procedure in which the device is not actively operated).

According to the North American Menopause Society, this syndrome affects roughly 27–84% of post-menopausal women and is most likely underdiagnosed and undertreated. The Society states that in most cases the symptoms can be managed effectively. The options include lubricants, moisturisers, vaginal oestrogen and DHEA, systemic hormone therapy (treatment that acts on the whole body) and one other medicine option. According to the Society, for mild symptoms, non-hormonal options available without a prescription give most women enough relief. The treatment is chosen by taking into account how severe your symptoms are, how effective and safe the option is for you, and your own preference.

Whether an effect differs from the placebo effect (an improvement caused simply by believing you are being treated) can be determined through blinded studies that compare the real treatment with a sham treatment. In a double-blind study in Australia (neither the patient nor the assessor knew which treatment was given), 85 women were randomly divided into two groups. After 12 months, there was no significant difference between fractional carbon dioxide laser and sham treatment in the change in symptom severity. In a double-blind study of 60 women in Belgium, the response at week 12 was also similar to that with sham treatment. Another study, of 72 women who had been treated for breast cancer and were taking an aromatase inhibitor, found that sexual function scores rose in both groups, but there was no significant difference between the groups.

A meta-analysis (an analysis combining the results of several studies) of seven randomised trials (trials in which participants are randomly assigned to groups) involving 407 women found that laser and sham treatment gave similar results on most measures, including sexual function, pain during sex, vaginal health score and satisfaction. Only one symptom scale showed a difference in favour of laser; when some studies were excluded from the analysis, a difference in favour of laser also appeared in the sexual function score. Although the researchers see laser as a promising option, they state that new, well-designed studies are needed.

An earlier systematic review found no difference in three randomised trials comparing laser with local hormone treatment. According to the review, the data are of low quality, and for now these treatments should only be used within research studies.

This does not mean that laser never changes symptoms in any woman; it means that controlled studies have not yet shown an effect that consistently differs from sham treatment. The diagnosis and treatment of menopausal symptoms are the field of gynaecology; nothing described here is offered as a replacement for that treatment.

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A feeling of looseness and stress incontinence

A feeling of vaginal laxity and stress incontinence (leaking urine when you cough, sneeze or exercise) are also complaints mentioned in the FDA’s communication on ‘vaginal rejuvenation’. The European Board and College of Obstetrics and Gynaecology (EBCOG) points out that the first-line treatment for stress incontinence and organ prolapse is a conservative, that is, non-surgical, approach.

Pelvic floor muscle training, meaning exercises that strengthen the muscles at the base of the pelvis that support the bladder, womb and bowel, is the most commonly used physiotherapy method for stress incontinence. A Cochrane review covering a total of 31 studies and 1,817 women found that women with this type of incontinence who had pelvic floor muscle training were about eight times more likely to report at the end of treatment that their symptoms had gone than women in groups who had no treatment or an inactive control treatment (56% compared with 6%). This comparison is based on four studies and 165 women; the review rates this evidence as high quality.

A systematic review of treatments for vaginal laxity, which included 38 studies in its analysis, found that sexual function scores rose after laser and radiofrequency in observational studies (studies in which participants are not randomly assigned to groups); however, this finding was not shown when only randomised trials were considered. When radiofrequency was compared with sham treatment, there was also no improvement on the laxity scale. The researchers stress that there is no standard definition of laxity. In a randomised trial of 87 women, complaints decreased in both the radiofrequency group and the pelvic floor muscle training group, and better results at six months were seen in the muscle training group; this trial had no sham treatment group.

A meta-analysis of six randomised trials and 577 patients comparing energy-based treatments with placebo for stress incontinence found no significant improvement compared with placebo; the researchers stated that the evidence is limited and that the result should be interpreted with caution. By contrast, two later multicentre sham-controlled trials reported more improvement in the erbium laser group than with sham treatment. In short, the results on this question are conflicting.

A feeling of sagging is also a complaint that needs to be assessed by gynaecological examination. ACOG lists vaginal prolapse and urinary incontinence among the clinical indications (medical reasons for treatment) that are kept separate from cosmetic procedures. EBCOG also states that there is no strong evidence to support the routine use of laser for these complaints.

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Hyaluronic acid for the labia majora

One of the injections mentioned under the heading of genital rejuvenation is hyaluronic acid (HA) filler in the outer labia (labia majora). This treatment is aimed at volume loss; it is not accepted as a treatment for vaginal dryness, a feeling of looseness or urinary incontinence.

In a single-centre randomised trial on this topic, 76 women were divided into two groups: one group had filler and the other had no treatment. No serious adverse events were seen; temporary, mild local reactions were reported. The researchers state that clinical data in this area are limited, and that their findings should be regarded as preliminary and supported by long-term research.

The same trial also reported a change in sexual function scores; however, the control group did not receive a sham treatment. Professional bodies also state that procedures intended to change sexual appearance or function without a medical reason have not been proven safe and effective. The evidence, risks and reversibility of outer labia filler are covered separately on the Genital Filler page.

RELATEDGenital Filler

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PRP and vaginal injections

Platelet-rich plasma (platelets are small cells in the blood), PRP for short, is an injection treatment prepared from a small sample of your own blood. In the genital area, it has been tried for sexual problems in women and for stress incontinence; for these uses, the level of evidence is low and there are few controlled studies.

A systematic review of PRP injections for these two uses brought together a small number of studies covering a total of 327 women. Most of the studies were observational; in the only randomised trial in the review, incontinence surgery (a mid-urethral sling: a supporting tape placed under the tube that carries urine) gave better results than PRP. The researchers state that the early results are promising, but that the level of evidence remains low because of methodological problems, and that high-quality research is needed.

Injections into the vulva (the external genitalia) and the vagina have also been tried for vaginal atrophy after menopause. In a small randomised trial comparing hyaluronic acid with PRP in 20 women, improvement was reported in both groups and no complications were recorded. However, the trial had no placebo group; the absence of complications in groups of ten women does not prove that complications are rare.

As explained in the section on menopause-related dryness and pain during sex, the diagnosis and treatment of vaginal atrophy are first a matter for gynaecological assessment. Injection treatments are not among the treatment options listed in the summary of the North American Menopause Society’s statement. Details of PRP treatments in the genital area are covered on the Genital PRP Treatments page.

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What do professional bodies say?

Professional bodies in obstetrics and gynaecology take a cautious approach to cosmetic genital procedures carried out without a medical reason. There is no high-quality evidence to support the claim that these procedures improve sexual function.

ACOG asks that women considering these procedures are told that there are no high-quality data supporting their effectiveness. According to ACOG, apart from clinical reasons such as pain during sex, vaginal prolapse and urinary incontinence, procedures intended to change sexual appearance or function are not medically necessary, carry significant risks, and their safety and effectiveness have not been proven. ACOG also recommends an assessment for body dysmorphic disorder (excessive preoccupation with a perceived flaw in appearance) when needed. If a psychological concern is suspected, it recommends referral to a specialist before a procedure is considered.

According to the SOGC’s 2013 guideline, there is little evidence that these procedures improve sexual satisfaction or self-image, and they should not be promoted as a way to enhance sexual function. The guideline recommends taking a full medical, sexual and gynaecological history (health background) and ruling out the possibility of coercion or abuse. According to the 2022 version of the guideline, most women requesting these procedures have normal genital anatomy, and up to 87% are reassured by counselling; procedures done for non-medical reasons cannot be supported, because there is no rigorous evidence.

According to EBCOG, before laser can enter routine use for menopausal symptoms, prolapse and urinary incontinence, high-quality evidence using patient-centred outcome measures (measures of the change the patient herself experiences) is needed first. The FDA also lists symptoms related to sexual function among the areas where the safety and effectiveness of energy-based devices have not been proven. For this reason, no expectations about sexual function are raised here; a complaint about your sex life is a matter for medical assessment in its own right.

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Limits of these treatments

Non-surgical genital treatments are not a substitute for a gynaecological diagnosis or treatment, and they have not been shown to solve problems with sexual function. The other limits depend on the method.

The word ‘rejuvenation’ does not describe a result; the SOGC regards the phrase as a marketing term that cannot be assessed scientifically. For energy-based devices, the FDA has stated that safety and effectiveness have not been proven for ‘vaginal rejuvenation’ or for symptoms related to menopause, urinary incontinence or sexual function.

For menopausal symptoms, two double-blind, sham-controlled trials found no significant difference between laser and sham treatment. For a feeling of looseness, the improvement in sexual function seen in observational studies could not be confirmed in randomised trials. For stress incontinence, the results of sham-controlled trials are conflicting. EBCOG points out that the first-line treatment for stress incontinence and prolapse is a conservative approach.

Hyaluronic acid filler in the outer labia is aimed at volume loss and is not a treatment for vaginal complaints; in the researchers’ own words, the data in this area are preliminary findings. For genital uses of PRP, the level of evidence is low, according to the systematic review’s assessment.

This information is given not to steer you towards one option, but so that you can compare the options. Which path makes sense for you – gynaecological treatment, pelvic floor muscle training, another treatment or none of these – is decided by the assessment at your consultation and by your own decision.

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Known risks

The FDA has stated that these treatments with energy-based devices can cause serious adverse events such as vaginal burns, scarring, pain during sex, and recurring or chronic pain. Controlled studies, however, have not reported serious events. These two findings do not cancel each other out, because they come from different sources and from observations of different sizes.

A study that reviewed the FDA’s database of device-related event reports found 45 events involving 46 patients, linked to laser and energy-based devices used for ‘vaginal rejuvenation’ between October 2015 and January 2019. The most commonly reported problem was pain. Of these patients, 33 said the problem was chronic; the problems reported included long-lasting pain, numbness, burning, bladder problems, infection, scarring, pain during sex and worsening of symptoms. The researchers note that the circumstances in which the events occurred are unclear.

Another study that later reviewed the same database found 39 event reports related to genital and urinary (genitourinary) uses, 32 of which were classified as injuries. The most commonly reported events were local reactions at the treatment site. Burns were reported more often with carbon dioxide lasers, and loss of sensation more often with radiofrequency devices. The researchers state that reporting needs to improve so that device safety can be fully assessed.

In controlled studies comparing the treatment with a sham treatment, adverse events occurred in similar numbers in both groups. In the Australian study, 16 events were reported in the laser group and 17 in the sham treatment group; these were vaginal pain or discomfort, spotting, discharge and lower urinary tract symptoms. In the Belgian study, no serious events were reported during follow-up of up to 18 months. The absence of serious events in small studies does not show that such an event never happens; it shows only that none was seen in that study.

The risks of injection treatments are covered separately on the Genital Filler and Genital PRP Treatments pages. ACOG asks that, before cosmetic genital procedures, patients are told about possible complications such as pain, bleeding, infection, scarring, adhesions, altered sensation and pain during sex.

RELATEDWhat should you ask before a treatment?

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