In a July 30 press release, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. warned consumers against the use of so-called “vaginal rejuvenation” devices that use energy-based lasers (or radiofrequencies) to reshape the vagina. These devices are being marketed by a growing number of manufacturers for purposes outside the bounds of their FDA approval.
The energy-based devices were approved by the FDA to treat serious health conditions in women, such as genital warts (condylomas) and the destruction of abnormal or pre-cancerous cervical or vaginal tissue. Instead, the FDA warns, manufacturers are marketing the devices to healthcare practitioners and consumers as a means for “vaginal rejuvenation,” an ill-defined term that is mostly associated with allegedly treating menopause symptoms or urinary incontinence, or improving sexual function.
FDA Warns Women Against Vaginal Rejuvenation
In his press release, FDA Commissioner Gottlieb reaffirmed his commitment to the promotion of women’s health. “We are deeply concerned women are being harmed,” Gottlieb wrote. “These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said Gottlieb, referring to the device’s use for alleged “rejuvenation.” He continued,
“The 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 of menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including women who’ve been treated for cancer, is egregious.”
Though “vaginal rejuvenation” is not a well-defined term, marketers are allegedly claiming their devices will generally treat:
- Vaginal laxity
- Vaginal atrophy, dryness, or itching
- Pain during sexual intercourse
- Pain during urination
- Decreased sexual sensation
To date, the FDA has not approved these energy-based devices for any of the above conditions.
Unapproved Uses of Device Could Cause Serious Harm
Medical articles and consumer reporting have cited cases of serious, adverse effects, such as vaginal burns or scars, increased pain during sexual intercourse, and chronic pain. Still, according to the FDA, “the full extent of the risks is unknown.”
Seven device manufacturers have been notified by the FDA of their concerns over improper marketing and use of their devices for “vaginal rejuvenation” treatments. The 7 companies are required to address the FDA’s concerns within 30 days. The companies notified are (in alphabetical order):
- Alma Lasers
- BTL Aesthetics
- BTL Industries
Next Steps: Be Wary, Exercise Caution
It is important, as with any medical treatment, that patients dedicate serious time researching, learning about, and going over possible procedures thoroughly with their healthcare providers. In closing his press release, Commissioner Gottlieb stated that “unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.”
Until these energy-based devices are assessed for their potential in performing “vaginal rejuvenation,” it’s safest to avoid using them for any other reason outside those specifically approved by the FDA. Only time will tell how manufacturers will respond to the FDA’s crack down, but Gottlieb’s statement is certainly an encouraging first step.
As always, the FDA urges any consumer who has been harmed by or is experiencing adverse effects as a result of receiving treatment from such devices, to report such issues to MedWatch, the FDA’s adverse-event reporting site.