The Food and Drug Administration issued a stern warning to doctors advising them against using laser or other energy therapies to treat sexual dysfunction and other problems affecting women after childbirth or menopause, saying it hasn't reviewed or approved the procedures.
"The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions," FDA Commissioner Scott Gottlieb said in a statement. "These products have serious risks and don't have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed."
The FDA said it sent letters to seven manufacturers about "inappropriate marketing" of their devices for vaginal rejuvenation procedures. The agency sent official "it has come to our attention" letters requesting more information on how the devices are being marketed. Although they don't explicitly state potentially disciplinary actions, the industry interprets the letters as a first warning to stop marketing products outside of their approved uses or face enforcement actions, including a mandatory recall or product seizure.
The treatment, which isn't usually covered by insurance, is often referred to as "designer vaginoplasty," "revirgination" or "G-spot amplification." It is becoming more popular as doctors use it as an option to relieve some of the symptoms that can cause painful intercourse after childbirth or menopause. It's heralded as an alternative therapy to traditional hormone replacement pills and creams.
Women may experience problems after childbirth, such as vaginal laxity, or stretching, which can decrease friction - and pleasure - during sex.
When women go through menopause, their levels of estrogen decrease. This can cause vaginal atrophy, or thinning of the vaginal walls, drying and inflammation that can make sex painful.
The devices used to perform the procedure are approved to treat some conditions, including destroying abnormal, pre-cancerous cervical or vaginal tissue as well as genital warts. But they aren't cleared to destroy or reshape vaginal tissue, which is done in vaginal rejuvenation.
The treatments are also being marketed to women with breast cancer, who go into menopause earlier, since they generally can't use hormonal replacement therapy.
"The deceptive marketing of a dangerous procedure with no proven benefit, including to women who've been treated for cancer, is egregious," Gottlieb said. The FDA has received two reports from manufacturers involving patients who experienced pain and bleeding after they underwent the treatment, as well as a dozen reports from patients who experienced significant pain and discomfort following the procedures.
The agency also reviewed 29 published studies describing a burning sensation or bleeding that lasted more than three days after the procedure. Last week, the FDA notified seven companies that their marketing might violate U.S. laws: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.
The American College of Obstetricians and Gynecologists recommends doctors inform patients about the lack of data supporting the efficacy and potential complications of vaginal rejuvenation and other similar procedures. Yet a simple internet search returns numerous ads from local doctors offering the treatment.
MonaLisa Touch, which is made by medical technology company Cynosure, is one of the more popular brands that sells its vaginal rejuvenation treatment. The company's patient website features photos and videos of older women recommending the therapy, saying it improved their sex life and was a good option for breast cancer survivors.
Hologic, which bought Cynosure last year, was the only company that commented for this article. The other six all declined or didn't immediately respond to requests for comment.
"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously," the company said in a statement. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements."
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