‘Vaginal rejuvenation’ devices ‘have serious risks,’ warn FDA
Many women who have gone through a vaginal birth, or through menopause, may experience laxity of the vaginal canal, damage to their pelvic floor, vaginal dryness, or impaired firmness of the vaginal wall.
These physiological changes can lead to other conditions, such as urinary incontinence, and they can affect a person’s sex life, as well as their general sense of well-being.
One practice that promises to address these issues, and which has been gaining popularity over the past few years, is that of so-called vaginal rejuvenation, in which energy-based devices — employing laser or radiofrequency — are used to stimulate vaginal tissue and allegedly help it to regain firmness, elasticity, and lubrication.
But the effectiveness and safety of such procedures have been questioned by researchers. Now, the United States Food and Drug Administration (FDA) have issued a warning stating that energy-based devices for “vaginal rejuvenation” can be unsafe and their use should be avoided.
“Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them from harmful products and deceptive medical claims,” asserts FDA Commissioner Dr. Scott Gottlieb in an official statement.
“Advancing the health of women is a priority for the FDA. […] And as part of [our] efforts, we also watch for, 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
FDA express ‘deep concern’
The FDA are no strangers to energy-based devices for gynecological use. In fact, they have previously greenlit such devices, 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 tool indications, including, but not limited to, the destruction of abnormal or pre-cancerous cervical or vaginal tissue and condylomas (genital warts).”
But using such devices to treat “symptoms related to menopause, urinary incontinence, or sexual function” can cause “serious adverse events,” emphasize the FDA. Of these adverse events, they name: vaginal burns, scarring, pain during sex, and recurring pain.
The agency condemns companies marketing such devices as safe for the treatment of symptoms such as vaginal laxity, vaginal atrophy, and decreased sensation during sex.
In fact, they have published a series of letters that they sent to companies promoting energy-based devices for “vaginal rejuvenation,” urging them to cease marketing such products in a deceptive manner.
In his official statement, Dr. Gottlieb notes, “We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function.”
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” he warns, adding: “We are deeply concerned women are being harmed.”
‘Egregious’ marketing practices
More specifically, the FDA are concerned about how energy-based devices may be deceptively promoted to women who may be in a vulnerable position, such as those who have recently been through cancer treatment.
“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,” says Dr. Gottlieb.
Since “vaginal rejuvenation” is not proven to be effective, and since it may lead to further physiological harm, the FDA Commissioner condemns such deceptive marketing practices as “egregious.”
The agency also addresses health care providers, reminding them that the FDA have not approved energy-based devices for cosmetic purposes or so-called vaginal rejuvenation.
For this reason, they also encourage health professionals to immediately inform MedWatch, the FDA-related watchdog, of any adverse events following a “vaginal rejuvenation” procedure, as soon as patients report them.
The FDA moreover promises to go on monitoring the use and and marketization of energy-based devices, as well as any emerging evidence speaking of their safety and effectiveness.
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