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

Typically during these procedures, a probe is inserted into the vagina to heat or laser the vaginal tissue.

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

The term "vaginal rejuvenation" has been used to describe non-surgical procedures meant to treat symptoms and conditions including vaginal laxity, atrophy, dryness or itching, pain during sexual intercourse or urination, and decreased sexual sensation. "The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.

The Food and Drug Administration is cracking down on manufacturers promising "vaginal rejuvenation", saying it could have serious side effects.

Meanwhile, FDA requested women to stop using these devices and encouraged them to discuss any of their sexual dysfunction problems and their treatments with their doctors.

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.

The cases were linked to energy-based devices, such as laser and ultrasound equipment, that were approved to treat conditions like removing genital warts. "The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue".

The FDA said they issued warnings over "inappropriate marketing" to device manufacturers Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. But it has found "numerous cases" of harm in adverse-event reports and published literature, he said.

Jane G. Mazur, a spokeswoman for Hologic Inc. whose subsidiary sells the MonaLisa Touch, said they were reviewing the FDA notice.

"Vaginal rejuvenation procedures claim to tighten the skin and the vaginal tissue beneath the skin by using various forms of energy devices", says Adeeti Gupta, M.D., a board-certified gynecologist and founder of Walk In GYN Care in NY. 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. Gottlieb explains that if the manufacturers don't rectify these concerns, "the FDA will consider what next actions, including potential enforcement actions, are appropriate".

However these devices are also being increasingly used for treatment of vaginal laxity, itching and dryness said the FDA.

"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said. Some of the companies such as Cynosure that is owned by Hologic Inc. state that they have based their treatments on science.

(Copyright © 2015. All Rights Reserved.)
 
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