The U.S. Food and Drug Administration (FDA) announced on Monday that it has sent warnings to several companies to cease their marketing of laser devices for procedures known as “vaginal rejuvenation.” The FDA says the treatments may be unsafe.
The lasers and energy-related devices were initially permitted for the treatment of serious conditions, like genital warts, cancer and surgery. In recent years, manufacturers have been marketing the lasers as treatment for symptoms related to urinary incontinence, sexual function, menopause and vaginal atrophy.
Some procedures use the laser to reshape the vaginal tissue, which purportedly solves issues related to dryness.
“These products have serious risks and don’t have adequate evidence to support for their use for these purposes,” said FDA commissioner Dr. Scott Gottlieb. “We are deeply concerned women are being harmed.”
Dr. Gottlieb also expressed concern that deceptive marketing of these devices may prevent women from getting the appropriate treatments for serious medical conditions.
While the lasers were only approved for certain treatments, it is legal for physicians to use them to treat off-label conditions.
One letter sent to BTL Industries notes how the company is promoting Exilis Ultra 360, a radio-frequency device, as a way to build collagen and elasticity in “female intimate parts.” The device was approved by the FDA for dermatology use. The agency has asked the company to furnish documentation that the device had been approved for its promoted vaginal uses.
The FDA has sent warning letters to manufacturers of Venus Fiore RF Ablation System, MonaLisa Touch, Femilift and other devices. The agency has asked these manufacturers to stop marketing them as vaginal rejuvenation procedures.
The full extent of the risks is unknown, the FDA says, but the agency has been made aware of cases of scarring, vaginal burns and lasting pain following the procedures. The FDA has received 14 reports of adverse events related to the treatments.