In some cases, women who've gone into early menopause after breast cancer treatments are opting for these interventions, but "the deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.
Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a risky procedure with no proven benefit".
Not only is vaginal rejuvenation likely ineffective when comes to its claims on sex drive, the FDA warns that the procedures come with other risky are downright unsafe.
The FDA said the full extent of the risks is unknown, but that the agency has found cases of vaginal burns, scarring, and lasting pain after the treatments. The FDA commissioner added that these "unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions".
"The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue". But the agency said the safety and effectiveness of the devices haven't been evaluated or confirmed for "vaginal rejuvenation".
FDA has sent a 30-day-notice to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton, for the inappropriate marketing of their devices for "vaginal rejuvenation" procedures.
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.
One of the companies that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch.
These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification".
If you suffered any adverse effects associated with these procedures, the FDA wants you to file a report through MedWatch.
In an official statement issued by the agency, Scott Gottlieb, FDA commissioner, says they are recently aware of an increasing number of companies claiming that their products provide vaginal rejuvenation to women.
However these devices are also being increasingly used for treatment of vaginal laxity, itching and dryness said the FDA.
In particular, the FDA was concerned about laser treatments as they have been known to potentially cause "serious adverse events, including vaginal burns [and] scarring".