All medical procedures come with some level of risk. Usually, information about procedures helps patients to make an informed decision about whether or not to get the treatment. Some experts, however, believe that women don’t have all the facts when it comes to vaginal cosmetic procedures popular today.

A number of procedures marketed under the terms “vaginal rejuvenation” or “cosmetic vaginal surgery” have been marketed with claims that the FDA believes may go beyond what’s truly been tested. For example, some of these procedures claim to “increase sexual gratification” although no clear medical testing or studies to this point have shown this to be a scientifically supported benefit of the treatment.

While the surgery risks for most women are low, with side effects happening in fewer than 1% of cases, the complications can develop quickly and cause other medical conditions if not caught quickly.

Although the vaginal rejuvenation procedure and others like it have become popular in recent years, the Food and Drug Administration and other experts in the medical industry are reporting their concerns over the promotion of cosmetic vaginal surgery.

According to statements from these experts and advocates, vaginal cosmetic surgery comes with risks that may outweigh the potential benefits and expose patients to the possibility of serious side effects. Some of these procedures under the umbrella of cosmetic vaginal surgery are known as vaginoplasty and labiaplasty.

Vaginoplasty is marketed as a procedure that allegedly tones up a woman’s vagina that has become loose from the aging process or from childbirth. Some surgeons offering this procedure argue that it even improves sensitivity, although this has been strongly debated by the American College of Obstetricians and Gynecologists.

Other procedures don’t involve surgery but instead use lasers and other energy-emitting devices to alter the vaginal tissue. These devices were approved by the FDA not for cosmetic applications but for treating real pathology, such as genital warts or pre-cancerous tissue. A variety of different side effects have been reported from women who have undergone these procedures, including scarring, burning, or pain during sex after the procedure.

The Food and Drug Administration has already issued a notice, warning patients and doctors about the problems and risks linked to vaginal rejuvenation lasers. FDA Commissioner Scott Gottlieb issued a statement in summer 2018 stating that the health claims marketed by these companies providing these procedures often come without an adequate presentation of the serious risks associated with treatments like vaginal rejuvenation.

These vaginal rejuvenation devices and procedures have reportedly been marketed to women with a variety of different health claims attached, such as that they could address urinary incontinence, overall sexual function or help with symptoms associated with menopause.

As argued in the FDA statement, however, those products have serious risks, and there is not enough scientific evidence at present to support the use for these purposes.

The FDA Commissioner shared at that time that representatives were deeply concerned that women were harmed based on these marketing campaigns. Recurring and chronic pain have already been named in adverse event reports and published literature. Seven different device manufacturers were notified about the FDA’s concerns over their marketing for cosmetic vaginal surgery.

Women who have already undergone these procedures and suffered significant consequences could have grounds to pursue a lawsuit against the maker.