‘Vaginal rejuvenation’ laser treatments can cause burns and pain, FDA warns

The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear the U.S. Food and Drug Administration warned Monday

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 risky and deceptive treatments.

"But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation, ' " he added.

"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously", Jane Mazur, a representative for Hologic, Inc., said in a statement.

The FDA said it was "deeply concerned" people were being injured with these procedures.

While these energy-based devices (radiofrequency or laser) have been approved for general gynecologic tool indications (i.e., destruction of abnormal or pre-cancerous cervical or vaginal tissue, condylomas), the Agency has become aware of some manufacturers marketing these devices for vaginal "rejuvenation" or vaginal cosmetic 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 FDA said they issued warnings over "inappropriate marketing" to device manufacturers Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

According to Scott Gottlieb, many manufacturers have marketed their devices as being useful in "vaginal rejuvenation" (a procedure that usually destroys or reshapes the tissue).

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If you're dealing with painful sex or other sexual dysfunction issues-or if you're just into the idea of having a more enjoyable sex life-the recent trendiness of vaginal laser rejuvenation might have seemed like a magic wand.

In particular, the FDA was concerned about laser treatments as they have been known to potentially cause "serious adverse events, including vaginal burns [and] scarring". However, a new warning from the Food and Drug Administration (FDA) has suggested women stay away from these procedures as they haven't yet been properly tested or approved by the FDA yet.

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said.

The agency posted copies of letters it sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore RF Ablation System and other devices, telling them to stop promoting them for the rejuvenation procedure.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb added.

We've been focused on advancing new policies to improve our oversight of device safety.

The FDA urges anyone who suffered a complication linked to a vaginal "rejuvenation" treatment to report it through MedWatch.

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