Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

"But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation, ' " he added.

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.

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 unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.

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.

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Gottlieb went on to note that the agency has reviewed patient reports and medical literature and found "numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain" from the treatments.

FDA has recently notified seven such manufacturers expressing high concern about the inappropriate marketing and requested that they respond within 30 days.

Although these devices have been approved to treat certain conditions, such as pre-cancerous lesions in the cervix, they have not been approved for vaginal rejuvenation, the FDA said.

Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.

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Monday, the FDA issued a statement warning that some of the "vaginal rejuvenation" treatments on the market can come with unsafe side effects, like vaginal burns, scarring, and pain.

Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a risky procedure with no proven benefit". 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. If its concerns are not addressed, the agency could take enforcement action. However these devices are also being increasingly used for treatment of vaginal laxity, itching and dryness said the FDA. FDA is committed to helping advance the development of safe, effective treatment options for these conditions. In addition, there are many reports of women being injured by these procedures. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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