Addressing the FDA Warning on Vaginal Rejuvenation Devices
On July 30, U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, released a statement concerning devices marketed for “vaginal rejuvenation.” He noted that, although the FDA has cleared or approved laser and energy-based devices for indications including the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas , none of these devices have been evaluated or confirmed by the FDA for “vaginal rejuvenation.”
The statement further points to numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain reported to the FDA and in the medical literature.
“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,” the statement reads.
It further cautions that “the deceptive marketing of unproven treatments may not only cause injuries but may also...
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