“Vaginal rejuvenation” is a much-debated expression that refers to the treatment of various physiological changes affecting a woman’s vaginal canal, vaginal wall, or pelvic floor — often after vaginal delivery or menopause.
Many women who have gone through a vaginal birth or menopause may experience relaxation of the vaginal canal, damage to their pelvic floor, vaginal dryness, or decreased vaginal wall firmness.
These physiological changes can lead to other conditions, such as urinary incontinence, and can affect a person’s sex life, as well as their general sense of well-being.
A practice that promises to address these issues, and which is gaining popularity in recent years, is that of so-called vaginal resuscitation, in which energy based devices — using lasers or radio frequencies — are used to stimulate the vaginal tissue and are supposed to help it regain firmness, elasticity and lubrication.
But the effectiveness and safety of such procedures were
“Our most fundamental obligation to the American public is to provide patients with access to safe and effective medical products to meet their health care needs and to protect them from harmful products and misleading medical claims,” said FDA Commissioner Dr. . Scott Gottlieb.
“Advancing women’s health is a priority for the FDA. […] And as part of it [our] we also strive to monitor and take action against bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers.”
FDA Commissioner Dr. Scott Gottlieb
The FDA is no stranger to energy-based devices for gynecological use. Indeed, such devices have been lit up in the past, but only for very specific clinical use and not as a cosmetic procedure or for “vaginal rejuvenation” treatments.
In their official warning they note that some energy-based devices “have [previously] received FDA clearance for general gynecologic device indications, including but not limited to the destruction of abnormal or precancerous cervical or vaginal tissue and warts (genital warts).
But using such devices to treat “symptoms related to menopause, urinary incontinence, or sexual function” can cause “serious side effects,” the FDA stresses. Of these side effects, they are called: vaginal burns, scarring, pain during sex and recurrent pain.
The agency condemns companies that have such devices as safe to treat symptoms such as vaginal laxity, vaginal atrophy and reduced sensation during sex.
In fact, they have published a number of
In his official statement, Dr. Gottlieb notes, “We have recently become aware of an increasing number of manufacturers marketing ‘vaginal resurfacing’ devices to women and claiming that these procedures will treat conditions and symptoms related to menopause, urinary incontinence, or sexual function. “
“These products carry serious risks and there is insufficient evidence to support their use for these purposes,” it warns, adding: “We are deeply concerned that women are being harmed.”
More specifically, the FDA is concerned about how energy-based devices can be misleadingly marketed to women who may be in a vulnerable position, such as those who have recently undergone cancer treatment.
“In some cases, these devices are marketed for this use in women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause,” says Dr. Gottlieb.
Since “vaginal resuscitation” is not proven effective, and since it can lead to further physiological damage, the FDA Commissioner condemns such deceptive marketing practices as “disastrous.”
The agency is also reaching out to healthcare providers, reminding them that the FDA has not approved energy-based devices for cosmetic purposes or so-called vaginal rejuvenation.
For this reason, they also encourage healthcare professionals to immediately notify MedWatch, the FDA-affiliated watchdog, of any adverse events following a “vaginal resuscitation” procedure as soon as patients report them.
In addition, the FDA promises to continue to monitor the use and marketing of energy-based devices, as well as any emerging evidence that speaks to their safety and effectiveness.
