Don't try to rejuvenate your vagina, FDA warns after scolding companies

Enlarge  Food and Drug Administration Commissioner Scott Gottleib is not

In fact, the FDA recently notified seven device manufacturers about inappropriate marketing of their devices for "vaginal rejuvenation" procedures, he pointed out.

"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said.

"In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain", according to Gottlieb's statement.

Opening up about this issue, a woman who used the "Thermiva" device from ThermiGen to treat her urinary incontinence said, "I was in so much pain. went to my OBGyn and she then informed me that I had bruising and she looked on the FDA website and told me that the product is not approved from FDA". If the companies fail to respond, the FDA said, it will consider next steps, which might include "potential enforcement actions".

As part of our efforts to promote women's health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts).

The FDA says vaginal rejuvenation devices have not gone through the correct approval process required to show they're effective, or let alone safe to use.

Vaginal rejuvenation is often used to describe a non-surgical procedure meant to relieve symptoms such as vaginal laxity, vaginal atrophy, dryness or itching, pain during sexual intercourse, pain during urination and decreased sexual sensation.

"The use of energy-based devices to perform vaginal 'rejuvenation, ' cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events", the warning said.

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. The FDA commissioner added that these "unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions".

One example of such device is the MonoLisa Touch laser procedure by Cynosure, advertised as a "long-lasting solution" for menopausal side effects. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".

He also encouraged women who've suffered problems after such procedures to report them to the FDA's MedWatch program. According to the FDA, it's received a number of complaints about burns and other damage arising from these treatments.

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