According to a warning from the United States Food and Drugs Administration (FDA), devices that are being sold for "vaginal rejuvenation" in women who are suffering from urinary incontinence or menopausal and sexual symptoms, can cause serious harm. According to the FDA, these "energy-based devices" (i.e., lasers), destroy and reshape vaginal tissue.
The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this goal.
"We're deeply concerned women are being harmed by these procedures", he added.
While these procedures are approved for as remedies for pre-cancerous cervical or vaginal tissue and genital warts, the FDA says they are not approved for use as vaginal rejuvenation treatments-even though some are being marketed as such.
As a further step, the FDA has sent notifications to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton.
But the FDA wants women to look out for their own safety, too.
"We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures", the FDA said in a statement.
"Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options", he advised.
There has been a growing number of dubious claims about vaginal rejuvenation treatments, which supposedly can cure incontinence or painful sex for older women. On its website, the company said, "During a treatment, a vaginal probe is inserted into the patient's vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response".
"The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb added.
We haven't reviewed or approved these devices for use in such procedures.
"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", said Gottlieb, in a statement. FDA did not take enforcement actions against the companies, but requested that they address the agency's concerns within 30 days.
In a move to improve their oversight of such devices, the FDA has also started building device safety registries. We've also established the Women's Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.