Vaginal Laser Treatments Can Cause Burns and Scarring, the FDA Says

Vaginal Laser Treatments Can Cause Burns and Scarring, the FDA Says

FDA Commissioner Scott Gottlieb said there are a growing number of manufacturers marketing these devices to women claiming the procedures will treat menopause, urinary incontinence or sexual function by destroying or reshaping tissue.

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.

"The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said in a statement.

In a safety communication, the FDA told patients and doctors that laser and radiofrequency devices approved to treat abnormal tissue have been improperly promoted to address sexual discomfort and vaginal dryness.

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.

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.

Experts say the "therapies", offered by some private clinics in the United Kingdom and the USA, pose a serious risk of burns, scarring and recurring pain.

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On 30 June, FDA Commissioner Scott Gottlieb, M.D. warned against laser treatment for "vaginal rejuvenation" or other procedure with a cosmetic objective. The company is one of several that was issued a letter from the agency prompting device manufacturers to respond within 30 days or face potential enforcement actions.

Meanwhile, FDA requested women to stop using these devices and encouraged them to discuss any of their sexual dysfunction problems and their treatments with their doctors. 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.

However, these devices have not been approved for so-called vaginal rejuvenation.

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said.

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".

We've been focused on advancing new policies to improve our oversight of device safety.

The American College of Obstetricians and Gynecologists has been cautioning against surgical "rejuvenation" procedures for more than a decade. We will keep the public informed if significant new information becomes available.

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