Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

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.

The agency said that it has approved such devices, which commonly use laser beams or radiofrequencies, for specific gynecologic uses, including the destruction of precancerous cervical or vaginal tissue and the removal of genital warts.

The agency has sent letters to various manufacturers about the "inappropriate marketing" for vaginal rejuvenation devices, saying they should stop promoting those products outside of their approved uses - should they fail to comply, they could face mandatory recalls and product seizures.

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The Food and Drug Administration on Monday announced that it had warned several companies to stop marketing laser devices for procedures billed as "vaginal rejuvenation", saying they were unsafe and deceptive treatments.

But, they highlighted the fact that it did not clear the devices for symptoms related to menopause, urinary incontinence or sexual function.

"It is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices". Gottlieb added that "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious". "We are deeply concerned women are being harmed", says the FDA warning.

Several manufacturers - Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen - were put on notice, and their device claims will be monitoring.

"In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain", according to Gottlieb's statement. The devices have not been approved for such use in sexual dysfunction. FDA did not take enforcement actions against the companies, but requested that they address the agency's concerns within 30 days. These products have serious risks and don't have adequate evidence to support their use for these purposes. Since December of 2015, Deborah Kotz, a press officer with the FDA, said the agency has received a dozen reports of complications related to these procedures.

"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 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". Parent company Hologic, Inc. said it is aware of the FDA warning.

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