By: Matthew Fischer
At the end of July, the U.S. Food and Drug Administration (FDA) issued a press release to alert health care providers and patients regarding the use of energy-based medical devices that are used to perform vaginal “rejuvenation” procedures. Although these devices have been approved to treat certain conditions, such as pre-cancerous lesions in the cervix, they have not been approved for cosmetic rejuvenation. According to the FDA, these procedures have at times been associated with serious adverse events such as burns, scarring, and chronic pain.
Many “rejuvenation” procedures are intended to treat symptoms and/or conditions such as vaginal laxity; pain during sexual intercourse; decreased sexual sensation; and vaginal atrophy, dryness, or itching. The FDA warning noted that it is aware that multiple device manufacturers may be marketing energy-based devices to treat these symptoms and/or conditions even though to date, the agency has not cleared or approved for marketing any energy-based devices to treat theses symptoms and/or conditions. Continue reading
