Vaginal 'Rejuvenation' Procedures Are Unproven, Pose Serious Risks, FDA Warns

The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear the U.S. Food and Drug Administration warned Monday

A large part of our work focuses on efforts to bring forth innovative, new products. For patients, the FDA suggests discussing any vaginal issues with your doctors.

"During a treatment, a vaginal probe is inserted into the patient's vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response".

"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously", Jane Mazur, a spokesperson for Hologic, Inc., said in a statement. "We are deeply concerned women are being harmed", says the FDA warning.

Some of the devices, which are commonly radiofrequency- or laser-based, have legit uses such as removing warts or pre-cancerous vaginal or cervical tissue. But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation'.

A company called BTL promised "a whole new approach to women's intimate health" using "a noninvasive, no downtime procedure with minimal risk".

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", the commissioner said.

But in a statement released Monday, the FDA said it's identified numerous cases of vaginal burns or scarring tied to vaginal rejuvenation, as well as post-procedural pain during sexual intercourse or recurring or chronic pain. Thus, the full extent of the risks is unknown.

If you suffered any adverse effects associated with these procedures, the FDA wants you to file a report through MedWatch.

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Officials with the FDA have notified 7 device manufacturers of their concerns about inappropriate marketing of these products for "vaginal rejuvenation" procedures. They are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. Answers from the companies have been sought within the next 30 days.

If the FDA's concerns are not addressed, the agency said that they will consider potential enforcement actions.

"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.

But their use to treat vaginal dryness, itching and laxity, the FDA said, has not been approved. As a result of this, women may end up experiencing more pain during sex than before the rejuvenation treatment. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.

In a move to improve their oversight of such devices, the FDA has also started building device safety registries.

These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification".

Over a dozen adverse reports after the use of these treatments have brought this issue to the forefront.


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