FDA warns about vaginal 'rejuvenation' device claims

Aug 03, 2018, 11:12
FDA warns about vaginal 'rejuvenation' device claims

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. "We are deeply concerned women are being harmed", Gottlieb said.

The FDA also noted in a safety alert that vaginal rejuvenation is often used to describe nonsurgical procedures that are meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during urination, among others.

USA regulator the FDA says it will take action if deceptive marketing of the "dangerous procedure with no proven benefit" continues.

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women's health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for "vaginal rejuvenation" [news release]. Needless to say that the FDA has yet to review, let alone recommend, these procedures.

"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", the agency said.

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.

Understand that the FDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function. But the FDA noted the devices haven't been evaluated or approved for vaginal rejuvenation.

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 fact, the FDA recently notified seven device manufacturers about inappropriate marketing of their devices for "vaginal rejuvenation" procedures, he pointed out.

One such company that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch. "These products have serious risks and don't have adequate evidence to support their use for these purposes", Gottleib said.

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".

However, these devices have not been approved for so-called vaginal rejuvenation. "But these reports indicate these procedures can cause serious harm", the FDA said. The administration says if the companies fail to address the issue within the notice period, it will take "potential enforcement actions". Some of the companies such as Cynosure that is owned by Hologic Inc. state that they have based their treatments on science.

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