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FDA Warns Against Horrifying Vaginal Trend

While there is some evidence that the mechanism behind these treatments can tighten vaginal wall tissue, more rigorous studies are needed to prove its safety and efficacy. In the meantime, patients could be experiencing severe complications. vchal/Shutterstock

From the rapid rise in vulva-reshaping labiaplasty procedures to the ongoing trend of labia bleaching, modern beauty ideals appear to be succeeding in convincing women that their genitals need to be improved from their natural state.

While the examples above involve external appearances, the popularity of internal enhancements promising to improve vaginal tightness and restore sexual function has also taken off. These treatments, called vaginal "rejuvenation", used to rely on invasive surgical techniques, but physicians and clinics are now peddling non-surgical versions of these services – supposedly offering the same results with little to no downtime – that employ laser and radiofrequency devices to alter the structure of vaginal tissue.


The problem with these energy-based treatments, aside from setting unrealistic feminine ideals, is that they involve off-label use of powerful devices that have not been proven to be safe for such applications.

Concerned by the increased marketing for these risky procedures, the FDA issued a statement earlier this week aimed at warning both consumers and health care providers.

“To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function,” the agency notes. “The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”

Laser and RF rejuvenation treatments are based on a relatively new medical concept called non-ablative hyperthermic mesenchymal regeneration, wherein an energy device that was designed to destroy tissue – for example, to remove potentially precancerous cervical lesions – is put on a lower setting so that it only heats tissue. This targeted heating has been shown to modify the collagen framework of connective tissue and stimulate the collagen-producing cells within.


According to a 2017 literature review in the International Journal of Women’s Health, several investigations have found that fractional CO2 and erbium YAG lasers and some RF devices can significantly improve so-called vaginal laxity and sexual functioning. Yet due to the small number of patients in each study, many OB-GYNs believe the evidence in favor is still lacking. Furthermore, many of the trials were performed by private physicians or cosmetic surgery centers who offer vaginal rejuvenation services, meaning their data is far from objective.

The manufacturers of seven energy-based devices have been sent official FDA Warning Letters because they have been marketing their ablative products for non-ablative use on the vaginal wall.

“We have contacted these manufacturers to share our concerns and will be monitoring their claims about uses of their products. In addition, we will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.”


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