The FDA has warned that equipment used in non-surgical vaginoplasty may pose serious health risks to women who undergo such procedures.

A safety communication issued in July 2018 cautions physicians and patients about FDA-approved surgical devices normally used for the removal of “abnormal or precancerous cervical or vaginal tissue” and genital warts are being marketed for “vaginal rejuvenation” – procedures for which they were not approved.

A study appearing in the International Journal of Women’s Health one year earlier warned that there is little clinical evidence for the effectiveness of vaginal rejuvenation, and indeed, are associated with a high rate of post-surgical complications.

What is Vaginoplasty?

Also marketed as “vaginal rejuvenation,” the term vaginoplasty broadly refers to a number of cosmetic procedures employed in order to alter or restore the appearance, size and/or tone of the vagina. It is also used to treat conditions such as vaginal dryness and atrophy as well as dyspareunia (painful intercourse).

These treatments are carried out using surgical lasers that are normally used for the removal of abnormal tissues, for which they have not been granted FDA clearance. Letters sent to manufacturers of these devices that are marketing them for such use warn that such promotions and sales may be in violation of the Food, Drug and Cosmetic Act.

Deceptive Marketing?

The FDA has also expressed concerns that these surgical laser devices and unapproved cosmetic use are being marketed to women in a deceptive manner. According to former FDA Commissioner Dr. Scott Gottlieb, “These devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause.”

One of the marketing techniques used by these manufacturers is the old tried and true “celebrity endorsement.” Famous female actors and social media stars have been hired by these companies to convince women that vaginoplasty will improve their appearance, improve their sex lives and address conditions resulting from childbirth and menopause. Dr. Gottlieb has warned that such procedures may result in greater physiological and psychological damage.

What are the Dangers?

There are general risks associated with surgical vaginoplasty that are common to all surgeries. These include infection, hemorrhaging and scarring as well as deep vein thrombosis (blood clots). However, there are also specific risks that can be extremely serious.

These include vaginal fistula, an abnormal passage connecting the vagina to the bladder, colon or other organ and vault prolapse. Vaginal stenosis, a loss of flexibility or narrowing normally caused by cancer radiation treatments, can also occur. Nerve damage is yet another risk, which can result in chronic pain and/or abnormal sensation (dysesthesia).

Alternatives to Vaginal Rejuvenation

The authors of the aforementioned study recommend that women who are considering vaginal rejuvenation first consider if there are psychological issues in play and seek counseling beforehand.

They also argue that many of the “problems” that lead women to undergo vaginoplasty are really related to a dysfunctional media and internet culture that has boiled the idea of healthy sexuality down to “mechanical performance,” ignoring the cultural and emotional aspects – none of which can be addressed surgically.