"Vaginal rejuvenation" procedures and devices unsafe says FDA

Henrietta Brewer
August 3, 2018

"We're deeply concerned women are being harmed by these procedures", he added.

The FDA also noted in a safety alert that vaginal rejuvenation is often used to describe nonsurgical procedures that are meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during urination, among others. They FDA has noted that these treatments are sold to women who have been treated for breast cancer early and experience menopausal symptoms.

But the FDA says these companies have not gone through the correct approval process to show that the treatments work as advertised, or even that they are safe. In these cases, the FDA had not reviewed or approved the used devices for the goal of 'vaginal rejuvenation'.

"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", Gottlieb said.

There are only a handful of cases that call for letting a laser anywhere near your vagina, according to the FDA-namely, "serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as [the treatment of] genital warts".

"These procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented", the group said in a 2007 statement.

The agency recently notified seven device manufacturers expressing concern about "inappropriate marketing" and requested that they respond within 30 days.

Today, we're warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared.

Hologic Inc., the parent company of Cynosure, told USA Today that it is aware of the FDA warning.

These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification".

The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this objective.

According to CNBC, 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". But it has found "numerous cases" of harm in adverse-event reports and published literature, he said.

Hologic, Inc., owner of Cynosure, replied to this with an email saying they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously".

Women who've experienced adverse side effects tied to vaginal rejuvenation devices are encouraged to report their problem to MedWatch, the FDA's adverse-event-reporting program, the agency said. "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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