FDA Issues Alert Regarding Energy-Based Devices Used for Vaginal 'Rejuvenation'

Posted By American Med Spa Association, Tuesday, July 31, 2018

Yesterday the US Food and Drug Administration issued a warning regarding energy-based devices (both radiofrequency and light-based) being used for vaginal rejuvenation. The alert focused on clarifying for consumers that there is no FDA-approved device for:
·       Vaginal laxity
·       Vaginal atrophy, dryness, or itching
·       Pain during sexual intercourse
·       Pain during urination
·       Decreased sexual sensation
·       Other conditions associated with this treatment
The statement does not indicate that medical aesthetic practices “shouldn’t” or “can’t” offer the procedure, however. Physicians still retain the ability to use these devices according to their own judgment with regard to efficacy and patient needs as long as they are trained, as is the case with any other off-label use of products.
For more information on this topic listen to AmSpa's Medical Spa Insider episode discussing this issue.
"Generally speaking, physicians are free to use devices 'off label' so long as they are trained in the off-label use and the treatment is, in the physician’s professional opinion, safe and appropriate,” according to AmSpa Founder/Director Alex Thiersch, JD. “The law allows for off-label use and it is up to the patient, in consultation with his or her physician, to consent to such use. Off-label use of prescription drugs and devices often provide great effect, but it is important for the physician to inform the patient of—and for the patient to understand—any risks and side effects from such use."
Stay tuned for more in-depth updates from the American Med Spa Association on this topic in the coming days and weeks, including additional legal information on what this may or may not mean for your practice.
In the meantime, be aware that consumers may have seen this news and may ask questions regarding the safety of this procedure, so be prepared to respond with the safety record and past successes of your devices and your practitioners. As always, AmSpa always urges practices to take the utmost care and caution when administering any and all medical aesthetic devices and treatments.
Click here to read the full text of the FDA alert.