On Monday July 30 the US Food and Drug Administration issued a warning to seven companies that advertise the procedures, which claim to do things like tighten vaginal walls, alleviate pain during sex or urination, increase sexual pleasure, or eliminate dryness. These devices have technically been approved for clearing pre-cancerous cells or genital warts as a result of a sexually transmitted infection. The American College of Obstetricians and Gynecologists has stated for more than 10 years that these procedures have not undergone rigorous clinical trials and are potentially dangerous. The FDA is asking women to report adverse effects from these procedures to MedWatch, its online consumer report database. Douching, or the act of squirting a liquid into the vagina, has been touted as necessary for cleanliness—and even erroneously promoted as a form of contraception and STI prevention— since the s. Skip to navigation Skip to content.
Studies have generally been limited to fewer than patients followed for 12 weeks or less. Companies are not informing doctors that the devices may not be FDA approved for the purposes advertised, nor are they providing adverse effects reports. Laser and radio-frequency procedures at best demonstrate temporary, marginal improvement in vaginal tone and dyspareunia, and at worst are associated with increased pelvic pain and dyspareunia, as well as vaginal, rectal, and bladder thermal burns. For those of us who specialize in cosmetic surgery, they have very limited benefit with a significant risk of injury to the patient even when properly used. Julio Cesar Novoa, MD , is a private practice ob.
Some manufacturers claim the devices can treat symptoms of menopause, problems with sexual function, and urinary incontinence. The devices work by using lasers or other energy sources to destroy or reshape vaginal tissue. The FDA has cleared or approved such devices in the past, but to kill pre-cancerous tissue and genital warts. In some cases, the FDA said, the devices are being marketed specifically to women who have gone through treatment for breast cancer and are experiencing early menopause. And, he added, the misleading marketing of unproven treatments might keep some women from receiving appropriate, evidence-based care for their conditions.
The term "vaginal rejuvenation" covers several different cosmetic procedures for female genitalia, such as labiaplasty and vaginoplasty. Vaginoplasty also known as posterior colporrhaphy is a procedure designed to tighten the vagina. An alternative is noninvasive vaginal tightening through heating tissues with radiofrequency waves or laser.