Published: Fri, August 03, 2018
Health Care | By Belinda Paul

FDA Sounds Alarm Over 'Vaginal Rejuvenation' Treatments

FDA Sounds Alarm Over 'Vaginal Rejuvenation' Treatments

"We requested that the manufacturers address our concerns within 30 days", said Gottlieb.

The FDA said "vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures meant to treat vaginal symptoms and/or conditions including, but not limited to: vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; and decreased sexual sensation".

"The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb added. The medical society has issued several statements noting that the devices, including the MonaLisa Touch, do not have FDA clearance or approval for treatment of menopausal symptoms, as advertised. In these cases, the FDA had not reviewed or approved the used devices for the goal of 'vaginal rejuvenation'. "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", writes Dr. Gottlieb. 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".

FDA also said that it has approved such devices which commonly use beams and radio frequencies for specific gynecologic uses including the destruction of precancerous cervical or vaginal tissue and also the removal of genital warts.

The laser devices used in vaginal rejuvenation are cleared for some medical uses.

As part of Monday's warning, the FDA announced it had notified seven companies about the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures" including: Alama Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said.

Scott Gottlieb, a commissioner of the FDA, recently stated that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal rejuvenation.

The companies involved say they are reviewing the warning letters from the FDA, which advises them to stop promoting the treatments. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate".

"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur said.

Two reports have been received by the FDA from manufacturers as well as dozens of reports from patients in relation to adverse effects as a result of vaginal rejuvenation procedures.

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