Gynecologists are hitting back at the Food and Drug Administration for declaring vaginal rejuvenation procedures ‘dangerous’.
Years ago, the agency approved the use of laser-based and energy-powered devices to removes genital warts or precancerous tissue in the vagina.
Recently, however, more and more clinics have been offering treatments to supposedly tighten up women’s genitals, repair weakened pelvic floor muscles, and even ‘rebalance’ the appearance of a woman’s labia.
And so, at the end of July, the FDA decided to take a stand: in a safety alert, commissioner Scott Gottlieb slammed the marketing of these devices to women is ‘deceptive’, and warns that using the devices for other purposes could lead to scarring, chronic pain, and burns.
But a growing wave of gynecologists are taking issue with the statement, saying there can be benefits to the procedure, and it is ‘irresponsible’ to scare women away from it.
Rejuvenated: Melissa Meeks, ex of ‘hot felon Jeremy Meeks, pictured getting a vaginal tightening procedure in September, shortly after her break-up
‘It was really disheartening and, quite frankly, I think irresponsible of the FDA to make that statement when we do have a very solid medical literature that shows otherwise,’ Dr Lauren Streicher, clinical professor of obstetrics and gynecology at Northwestern University, told NPR.
The heated tool is usually used in a few five-minute sessions spaced out over a few weeks.
A wand type instrument attached to a laser is inserted in to the vagina. It is performed while the patient is awake and is relatively painless.
Clinics promoting the wand for cosmetic procedures say the energy stimulates collagen production and enhancing blood flow, promising vagina that are ‘restored’ to a younger appearance.
But they are also promoted to treat dryness, thinning of the vaginal walls, and inflammation, which can be brought on by menopause or childbirth.
Speaking at the end of July, Dr Gottlieb released a statement, saying the products ‘have serious risks and don’t have adequate evidence to support their use for these purposes,’ adding: ‘We are deeply concerned women are being harmed.’
Dr Streicher took issue with his wording.
‘The message to the consumer is very confusing because it really lumps it all together,’ she explained, referring to the various ways you can use the wand device.
Her words were echoed by fellow OB/GYN Hope Ricciotti, MD, editor in chief of Harvard Women’s Health Watch.
Writing in a blog post, Dr Ricciotti said: ‘I have concerns that the FDA, in an overabundance of caution, may limit availability of innovative therapies, which when used correctly may benefit women’s reproductive health.’
She adds, however, that there has been some misinformation about the product.
Indeed, ‘vaginal rejuvenation’ has become a favorite activity among reality stars and the like. Brandi Glanville, Farrah Abraham, Sonja Morgan, and Jeremy Meeks’ ex Melissa, among others, have gleefully told fans about their procedures – some even sharing pictures from inside the clinic – without specifying medical issues, or what the device is used for.
One of the most popular clinics among reality stars like Farrah Abraham is the Beverly Hills Rejuvenation Center, which tells patients this wand procedure can correct all manner of things, including:
- Uneven, hanging, large, or wrinkled labia minora
- Pain and discomfort caused by sports and physical exertion
- Odor and hygiene concerns
- Decreased sensation during sexual intercourse
- Multi-directional urine streams
- Stress incontinence
Gottlieb is, clearly, incensed by these claims, urging clinics that preying on the common insecurities among women is abhorrent.
‘[T]he safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’
‘In addition to the deceptive health claims being made with respect to these uses, the ‘vaginal rejuvenation’ procedures have serious risks.
‘In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.’
As a result of Gottlieb’s concerns, seven manufacturers have been warned to adjust their marketing accordingly to make clear that they have not been approved for vaginal rejuvenation.
Those brands are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.
THE RISE OF THE ‘DESIGNER VAGINA’
Beyond the rise in non-invasive ‘rejuvenations’, plastic surgery in general is experiencing a boom. Last year, Americans spent a record $16 billion on procedures.
The most popular operation was Botox, a non-invasive face-tightening procedure, followed by collagen injections, another non-invasive facial operation.
Breast augmentations were the third most-popular, and easily the most popular invasive procedure.
According to the American Society for Aesthetic Plastic Surgery, more than 5,000 women underwent the procedure in 2013.
As of 2015, that figure was estimated to have risen to around 8,745 women.
It is equally popular in the UK, particularly among young girls.
In 2015/16 more than 200 girls under 18 had the operation, known as a labiaplasty, on the NHS. More than 150 of the girls were under 15.