As of yesterday, the warning letters were delivered to Inmode MD Limited, BTL Aesthetics, Thermigen Inc., Sciton, Alma Lasers, Cynosure, and BTL Industries. A warning against vaginal rejuvenation procedures was also issued to the general public.
The FDA’s Warning Letter Procedure states that, when it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the FDA’s practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action, and that they are only issued for violations of regulatory significance.
The FDA claims that it has received complaints of physical harm and even burns from patients who have received vaginal rejuvenation treatments, and that not only are the devices and treatments not yet approved, but are causing the vaginal discomfort that they claim to resolve.
“We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function,” says FDA Commissioner Dr. Scott Gottlieb.
“The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
“We’re working to improve evidence generation about the safety and effectiveness of health technologies in clinical areas that are unique to women.”
So far, the FDA has approved laser and energy-based devices to treat more serious conditions such as genital warts and abnormal or pre-cancerous cervical and vaginal tissue, but has not yet evaluated or cleared these devices for “vaginal rejuvenation” treatments.
Although the term itself is ill-defined, says the FDA, it is sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to:
- Vaginal laxity
- Vaginal atrophy, dryness, or itching
- Pain during sexual intercourse
- Pain during urination
- Decreased sexual sensation
The manufacturers served with warning letters have been advised to address these concerns within 30 days, with the following recommendations issued to healthcare providers:
- Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal 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.
- Discuss the benefits and risks of all available treatment options for vaginal symptoms with your patients.
- If any patients experience adverse effects from procedures that involved the use of energy-based devices to perform vaginal “rejuvenation”, cosmetic procedures, or treat genitourinary symptoms of menopause, sexual dysfunction, or urinary incontinence, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Currently in Australia, one of the leaders in vaginal rejuvenation is Syneron Candela and their CO2RE Intima device, which is TGA approved.