Hologic's (HOLX +1.7%) Cynosure unit is one of seven manufacturers warned by the FDA over their marketing of energy-based devices, including lasers, for "vaginal rejuvenation", an unapproved indication.
Treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to burns, scarring, pain during sexual intercourse, and recurring/chronic pain.
The agency has sent letters to various manufacturers about the "inappropriate marketing" for vaginal rejuvenation devices, saying they should stop promoting those products outside of their approved uses - should they fail to comply, they could face mandatory recalls and product seizures.
Not only is vaginal rejuvenation likely ineffective when comes to its claims on sex drive, the FDA warns that the procedures come with other risky are downright unsafe.
The agency originally permitted the lasers and related energy-based devices onto the market for treatment of serious conditions, like cancer, genital warts, or surgery including hysterectomies. Needless to say that the FDA has yet to review, let alone recommend, these procedures. We requested that the manufacturers address our concerns within 30 days.
So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate". FDA is committed to helping advance the development of safe, effective treatment options for these conditions. We will keep the public informed if significant new information becomes available.
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. 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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