Laser devices are being used more and more for the purpose of “vaginal rejuvenation,” treatments that purportedly address symptoms related to childbirth or the normal progression of aging. But the FDA says it has not approved gynecological laser devices for this use, nor found these treatments to be effective.

Indeed, these laser treatments may even lead to serious complications. If you or someone you love suffered from complications after use of a MonaLisa Touch laser device, you may be able to file a MonaLisa Touch lawsuit.

Vaginal rejuvenation treatment is, according to the U.S. Food and Drug Administration, an “ill-defined” thing. It is a rather general term, used to cover a variety of treatments or processes meant to help with abnormal or precancerous cervical or vaginal tissue, as well as warts.

While vaginal rejuvenation treatment is sometimes used for other conditions, the FDA says these devices have not yet approved vaginal rejuvenation treatment for problems like vaginal atrophy, urinary incontinence, or reduced sexual function.

Gynecologists File MonaLisa Touch Lawsuit

A group of gynecologists from a Rhode Island practice filed a class action lawsuit in August 2018 against Cynosure, the cosmetic laser manufacturer responsible for the MonaLisa Touch. According to the MonaLisa Touch lawsuit, Cynosure deceptively marketed this cosmetic laser system as a vaginal rejuvenation system.

The gynecological practice, Three R LLC, notes that the FDA released a warning against the use of energy-based devices for so-called “vaginal rejuvenation”. The MonaLisa Touch lawsuit notes that this essentially renders the system (leased for more than $200,000) worthless for this use.

“[Cynosure] has unabashedly marketed and sold its MonaLisa Touch laser system as a vaginal rejuvenation device with promises that it will increase intimacy and improve sexual function—which, as the FDA can hardly have been clearer—are purposes for which it was not approved by the FDA and for which use there is no proven benefit,” argued Three R in the MonaLisa Touch lawsuit.

FDA Vaginal Rejuvenation Warning

The FDA commissioner, Scott Gottlieb, referred to vaginal rejuvenation treatment as using “deceptive” marketing. Manufacturers of these treatments have made bold claims in their advertising, some suggesting that vaginal rejuvenation treatment with lasers can treat issues from the vaginal wall, canal, and pelvic floor to breast cancer treatment complications.

The FDA warns that vaginal rejuvenation treatment using energy-based devices may lead to major issues like burning, scarring, and chronic pain.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” FDA Commissioner Gottlieb said to Medical News Today. “We are deeply concerned women are being harmed.”

The FDA has received at least 14 reports of adverse events related to vaginal rejuvenation treatment, including burning and significant pain. The agency has sent letters to a number of manufacturers, telling them not to promote these devices for use in vaginal rejuvenation procedures.

Filing a MonaLisa Touch Lawsuit

An investigation has been launched into the claims manufacturers of these energy-based devices have made regarding vaginal rejuvenation treatment. Experienced attorneys are looking for people who have suffered side effects of vaginal rejuvenation treatment, which may include problems like burning, scarring, or pain during sex.

If you or someone you love has suffered from complications from vaginal rejuvenation treatment with a MonaLisa Touch, you may be able to join a MonaLisa Touch lawsuit investigation. While filing a MonaLisa Touch lawsuit cannot undo the damage caused by vaginal rejuvenation treatment gone wrong, it can help to alleviate the financial burden caused by medical expenses and lost wages.

The MonaLisa Touch Lawsuit is Case No. 3:18-cv-30133, in the U.S. District Court for the District of Massachusetts.