The federal agency has sternly cautioned against the use of these treatments, warning doctors not to resort to using laser or other energy therapies to treat sexual dysfunction or other issues affecting women following childbirth or menopause.
"The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said in a statement.
The Food and Drug Administration (FDA) has issued an alert to healthcare providers concerning the use of energy-based devices for vaginal "rejuvenation", a term used to describe non-surgical procedures meant to treat vaginal laxity, atrophy, dryness, or itching; pain during sexual intercourse or urination; or for decreased sexual sensation.
"Deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb fumed in one tweet.
But their use to treat vaginal dryness, itching and laxity, the FDA said, has not been approved. Needless to say that the FDA has yet to review, let alone recommend, these procedures.
The use of these vaginal rejuvenation devices has been found to cause side effects including vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
"The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions", Gottlieb said. According to the FDA, these "energy-based devices" (i.e., lasers), destroy and reshape vaginal tissue. Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen have all been contacted already.
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"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said.
Hologic Inc., the parent company of Cynosure, told USA Today that it is aware of the FDA warning.
The FDA has requested that the manufacturers address the concerns within 30 days.
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".
The idea is that the vaginal rejuvenation process will help boost sexual desire and sexual function, but there's just one problem: These claims are probably all BS, says Dr. Gupta. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".
If you have undergone treatment for vaginal "rejuvenation" and experienced a complication, file a report through the FDA's MedWatch.
So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done.