“Vaginal resurfacing” procedures — advertised as a cure for incontinence or painful sex for older women — can actually lead to “serious adverse events, including vaginal burns, scarring” and even more pain during intercourse, feds said. health officials on Monday.
The Food and Drug Administration has issued a stern warning to doctors advising them not to use lasers or other energy therapies to treat sexual dysfunction and other problems affecting postpartum or menopausal women, saying it has not reviewed or approved the procedures. .
“Misleading marketing of unproven treatments can not only cause injuries, but can also prevent some patients from accessing appropriate, recognized therapies to treat serious medical conditions,” said FDA Commissioner Scott Gottlieb. “These products carry serious risks and there is insufficient evidence to support their use for these purposes. We are deeply concerned that women are being harmed.”
The FDA said it sent letters to seven manufacturers about “improper marketing” of their devices for vaginal resuscitation procedures. The agency sent official letters “it has come to our attention” asking for more information about how the devices were marketed. While they do not explicitly state potential disciplinary actions, the industry interprets the letters as a first warning to stop marketing products outside of their approved uses or face enforcement action, including a mandatory recall or seizure of product.
The treatment, which is usually not covered by insurance, is often referred to as “engineered vaginoplasty,” “reproduction,” or “G-spot enhancement.” 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 is advertised as an alternative treatment to traditional hormone replacement pills and creams.
Women may experience problems after giving birth, such as vaginal relaxation or stretching, which can reduce friction – and pleasure – during sex.
When women go through menopause, their estrogen levels drop. This can cause vaginal atrophy, or thinning of the vaginal walls, dryness and inflammation that can make sex painful.
The devices used to perform the procedure are approved to treat certain conditions, including the destruction of abnormal, precancerous cervical or vaginal tissue, as well as genital warts. But they are not cleaned to destroy or remodel the vaginal tissue, which is done in vaginal rejuvenation.
Treatments are also being marketed to women with breast cancer who enter menopause earlier because they generally cannot use hormone replacement therapy.
“The misleading marketing of a dangerous procedure with no proven benefit, including to women who have been treated for cancer, is outrageous,” Gottlieb said. The FDA has received two reports from manufacturers of patients who experienced pain and bleeding after treatment, as well as a dozen reports from patients who experienced significant pain and discomfort after the procedures.
The agency also reviewed 29 published studies that described a burning sensation or bleeding that lasted more than three days after the procedure. Last week, the FDA notified seven companies that their marketing may violate US law: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.
The American College of Obstetricians and Gynecologists recommends doctors informs patients about the lack of data to support the effectiveness and potential complications of vaginal resuscitation and other similar procedures. However, a simple internet search returns many advertisements from local doctors offering the treatment.
MonaLisa Touch, which is manufactured by medical technology company Cynosure, is one of the most popular brands selling vaginal rejuvenation treatment. The patient of the company the site has photos and videos of older women who recommended the treatment, saying it improved their sex lives and was a good option for breast cancer survivors.
Hologicwhich bought Cynosure last year, was the only company to comment on this article. The remaining six declined or did not immediately respond to requests for comment.
“As a leader in women’s health, Hologic has a strong history 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 fully and will work with the agency to ensure that all product communications comply with regulatory requirements.”
