New York: The use of lasers and other medical devices for vaginal "rejuvenation" treatments and similar cosmetic procedures have been warned against by the Food and Drug Administration (FDA), after such treatments were found to be potentially harmful.
Vaginal Rejuvenation Laser Treatments Can Cause Chronic Pain And Burns, FDA Warns
The warning was issued regarding "energy-based" devices that promise to treat vaginal conditions and symptoms through laser therapy.
Treatments such as vaginal rejuvenation claim to help with issues related to menopause, such as vaginal laxity or dryness, urinary incontinence, or pain during sex, however, the "safety and effectiveness" of these procedures has not been established, according to the FDA.
Many vaginal rejuvenation treatments also claim to tighten the vaginal canal.
Rather than help with vaginal issues, cosmetic procedures using energy-based devices may result in vaginal burns, scarring, pain during intercourse, or recurring, chronic pain, the FDA said.
Currently, energy-based devices have clearance for medicinal use only in the destruction of precancerous cervical or vaginal tissue and genital warts.
To stop the falsely-marketed treatments, the FDA issued seven letters to companies offering vaginal rejuvenation procedures.
"These products have serious risks and don't have adequate evidence to support their use for these purposes," said Dr. Scott Gottlieb, the F.D.A. commissioner. "We are deeply concerned women are being harmed."
One company issued an "inappropriate marketing" warning, Cynosure, offers a procedure called the MonaLisa Touch, which claims to have "virtually no side effects," according to its website.
The American College of Obstetricians and Gynaecologists (ACOG) previously issued a statement on vaginal laser treatment, stating: "Obstetrician-gynaecologists should be cognisant of the evidence regarding innovative practices, and should be wary of adopting new or innovative approaches on the basis of promotions or marketing."
In response to the FDA warning, ACOG vice president Christopher Zahn, MD, told The Independent: "The ACOG has cautioned health care providers and patients about the risk of using laser technologies for so called 'vaginal rejuvenation' procedures or treatment of vaginal atrophy. ACOG is pleased that this week's announcement from the FDA aligns with and affirms our position that the data to support the safety and efficacy of these procedures for these indications is markedly limited.