The US Food and Drug Administration (FDA) is cracking down on manufacturers marketing the use of laser or other energy-based devices for "vaginal rejuvenation" which manufacturers claim will treat conditions and symptoms related to menopause, urinary incontinence, or sexual function.
"The procedures use lasers and other energy-based devices [such as radiofrequency] to destroy or reshape vaginal tissue. These products have serious risks and do not have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed," FDA Commissioner Scott Gottlieb, MD, said in a statement.
The FDA has cleared laser and energy-based devices for destroying abnormal or precancerous cervical or vaginal tissue, as well as condylomas (genital warts) and other serious conditions. But the safety and effectiveness of these devices have not been evaluated or confirmed by the FDA for "vaginal rejuvenation," Gottlieb stressed.
It notes that "vaginal rejuvenation" is an "ill-defined" term; however, it is sometimes used to describe nonsurgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to, vaginal laxity, vaginal atrophy, dryness or itching, pain during sexual intercourse, and decreased sexual sensation.
Marketing to Cancer Patients, Reports of Serious Harm
In some cases, these devices and procedures are even being marketed to women who have completed breast cancer treatment 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," said Gottlieb.
He said the FDA is aware of "numerous" reports of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain following "vaginal rejuvenation" procedures. The "full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm."
"Today, we're warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared," Gottlieb urged.
FDA Will Tackle "Bad Actors"
The FDA has cited seven device manufacturers for inappropriate marketing of their devices for "vaginal rejuvenation" procedures. They are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and ThermiGen.
The companies have 30 days to address the FDA's concerns. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement, are appropriate. This matter has the full attention of our professional staff," Gottlieb asserted.
He added that the FDA will continue to 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."
Health providers are asked to report adverse events related to these devices to MedWatch, the FDA's safety information and adverse event reporting program. FDA also refers healthcare providers to a May 2016 position statement on fractional laser treatment of vulvovaginal atrophy by the American College of Obstetricians and Gynecologists.