FDA Warns of Unapproved Vaginal ‘Rejuvenation’ Procedures

August 1, 2018  Source: Medpagetoday 168


The US-FDA has warned against medical device manufacturers for developing cosmetic vaginal rejuvenation procedures to treat vaginal atrophy, laxity, itching/dryness, pain during sex or urination and reduced sexual sensation.

The FDA agency stated, "The safety and effectiveness of energy-based medical devices to perform these procedures has not been established; 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."

The FDA claimed that these therapies could lead to serious side effects such as vaginal pain, burns or scarring. The FDA Commissioner Scott Gottlieb, MD, said "In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause; The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious."

Several other manufacturers including Thermigen, Alma Lasers, BTL Industries, BTL Aesthetics, InMode, Cynosure and Scitonwere also put out similar notice. Gottlieb said, "We requested that the manufacturers address our concerns within 30 days; If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate."

By Ddu