On July 30, 2018 the FDA released a statement regarding “vaginal rejuvenation” devices. The warning says there could be some serious adverse reactions like burning or scarring– the FDA is “concerned women are being harmed” (1). The FDA says that some doctors are using vaginal probes in a manner not consistent with what has been FDA approved and urges women to be aware. (See the link at the bottom for the official FDA statement.)
I would like to reassure you that the probe used for MonaLisa Touch is safe for women and has the most data available regarding its safety. The issues with the FDA are not with the MonaLisa Touch CO2 Laser, they are with the other types of vaginal devices on the market. There are a variety of vaginal devices out there that treat a variety of conditions, and you do not need to be a gynecologist or urologist to use them in your practice– they could be used by a plastic surgeon or a dermatologist even. But MonaLisa Touch technology can only be used by a doctor who is an OB/GYN or Urologist.
Although we appreciate the FDA warning ladies about potential safety issues with products, they didn’t make it clear that the technology behind MonaLisa Touch is safe. Instead, they may have scared some ladies away from a wonderful procedure that could really make a difference in their life, especially if they are a cancer survivor or cannot take hormones. Moral of the story– stick with MonaLisa Touch and call us for a consultation. Our MonaLisa Touch Chico number is 530-270-9621.
Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”. July 30, 2018. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm615130.htm.