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.
The FDA warning came in the form of “It has Come to Our Attention” letters to seven device manufacturers. These letters are used in situations where the agency becomes aware that a regulated industry may be promoting a product in a manner that potentially violates a law or regulation. These letters are aimed at gathering more information and do not automatically equate to anticipated future enforcement action.
There are several takeaways at this point. First, the FDA stopped short of issuing formal warning letters threatening enforcement action. Even though the safety and effectiveness of the devices to perform these procedures has yet to be established in the eyes of the agency, the agency did not instruct patients to cease having these treatments nor did it try to push physicians to stop on their end. Secondly, physicians need to ensure that patients are aware that some devices do not have specific FDA approval for the intended use and further, that patients understand the risks and benefits of all treatments available. Essentially, this is part of the process of informed consent. The manufacturers were given 30 days to respond. The industry will be watching closely.