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Published: Fri, August 03, 2018
Medical | By Garry George

Vaginal 'Rejuvenation' Procedures Are Unproven, Pose Serious Risks, FDA Warns

Vaginal 'Rejuvenation' Procedures Are Unproven, Pose Serious Risks, FDA Warns

The agency said that it has approved such devices, which commonly use laser beams or radiofrequencies, for specific gynecologic uses, including the destruction of precancerous cervical or vaginal tissue and the removal of genital warts.

On 30 June, FDA Commissioner Scott Gottlieb, M.D. warned against laser treatment for "vaginal rejuvenation" or other procedure with a cosmetic objective.

As a further step, the FDA has sent notifications to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton.

They were given 30 days to address the FDA's concerns. "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious".

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".

"The safety and effectiveness of energy-based devices for treatment of these conditions has not been established". In these cases, the FDA had not reviewed or approved the used devices for the goal of 'vaginal rejuvenation'.

Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions.

In some cases, women who've gone into early menopause after breast cancer treatments are opting for these interventions, but "the deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.

Commissioner Scott Gottlieb, in a statement, said the products have serious risks, have not been reviewed or approved for use in such procedures and don't have adequate evidence to support the claims. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain. There is little scientific basis for the use of these methods state the FDA.

In a statement, Jane Mazur, Hologic's vice president of global divisional communications, said that "Hologic has a strong track record of rooting our products in science and clinical evidence" and that it is "evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".

The FDA says that companies offering these services haven't gone through the correct approval process to demonstrate the treatments work as advertised, or even that they're safe.

BTL and Cynosure, a division of Hologic, said they were reviewing the warning letters.

Women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and who are seeking alternative nonhormonal options, may be particularly drawn to "vaginal rejuvenation" devices, ' according to the agency.

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