FDA warns of vaginal 'rejuvenation' promises of better sex, menopause treatment

03 August, 2018, 11:09 | Author: Veronica Peterson
  • ‘Vaginal rejuvenation’ laser treatments can cause burns and pain, FDA warns

Monday, the FDA issued a statement warning that some of the "vaginal rejuvenation" treatments on the market can come with risky side effects, like vaginal burns, scarring, and pain.

So-called vaginal rejuvenation is a vague term that might refer to vaginal "laxity", dryness, pain during intercourse or "decreased sexual sensation", the FDA said in a safety alert. The devices have not been approved for such use in sexual dysfunction.

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.

"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 procedures use lasers or radiofrequency devices to destroy or reshape vaginal tissue.

The lasers and ultrasound equipment used in these unapproved treatments have FDA approval for some procedures, such as removing genital warts and hysterectomies, but not for the "vaginal rejuvenation" purposes claimed by a number of manufacturers (and promoted by celebrities such as Kim Kardashian and Jada Pinkett Smith).

The agency recently notified seven device manufacturers expressing concern about "inappropriate marketing" and requested that they respond within 30 days.

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"To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence or sexual function", the FDA said. Parent company Hologic, Inc. said it is aware of the FDA warning.

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".

Commissioner Scott Gottlieb, in a statement, said the products have serious risks, have not been reviewed or approved for use in such procedures and don't have adequate evidence to support the claims. We've also established the Women's Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.

"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur said.

He also encouraged women who've suffered problems after such procedures to report them to the FDA's MedWatch program.

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.


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