But, the agency notes, there's no proof that these devices are effective for any of the "rejuvenating" procedures companies claim and some celebrities promote. These products have serious risks and don't have adequate evidence to support their use for these purposes. "We are deeply concerned women are being harmed", said Gottlieb.
While these energy-based devices (radiofrequency or laser) have been approved for general gynecologic tool indications (i.e., destruction of abnormal or pre-cancerous cervical or vaginal tissue, condylomas), the Agency has become aware of some manufacturers marketing these devices for vaginal "rejuvenation" or vaginal cosmetic procedures. The statement adds, "The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain". It's sent warning letters to seven companies, including Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.
But the FDA wants women to look out for their own safety, too.
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"Vaginal rejuvenation procedures claim to tighten the skin and the vaginal tissue beneath the skin by using various forms of energy devices", says Adeeti Gupta, M.D., a board-certified gynecologist and founder of Walk In GYN Care in NY. The FDA also encourages women suffering from vaginal or sexual dysfunction problems to discuss their symptoms and potential treatments with their health care provider. The devices are not created to work on large areas or for reshaping procedures such as those performed during vaginal rejuvenation.
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 unsafe procedure with no proven benefit". He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures.
In particular, the FDA was concerned about laser treatments as they have been known to potentially cause "serious adverse events, including vaginal burns [and] scarring".
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"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", Gottlieb continues.
The laser and ultrasound equipment used in these unapproved procedures has FDA approval for removing genital warts, other growths and in operations such as hysterectomies. Since December of 2015, Deborah Kotz, a press officer with the FDA, said the agency has received a dozen reports of complications related to these procedures. As part of our Medical Device Safety Action Plan and our ongoing commitment to advancing women's health, we've begun building out important device safety registries.
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