FDA warns about vaginal 'rejuvenation' device claims

The FDA warned against

The FDA warned against"vaginal rejuventation treatments

A large part of our work focuses on efforts to bring forth innovative, new products.

The FDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function. The devices are not created to work on large areas or for reshaping procedures such as those performed during vaginal rejuvenation.

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. We are deeply concerned women are being harmed.

While these procedures are approved for as remedies for pre-cancerous cervical or vaginal tissue and genital warts, the FDA says they are not approved for use as vaginal rejuvenation treatments-even though some are being marketed as such.

"But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation, ' " he added.

A company called BTL promised "a whole new approach to women's intimate health" using "a noninvasive, no downtime procedure with minimal risk". He explains that these treatments can cause vaginal burns, pain, and scarring.

National Archives: We can't produce all Kavanaugh docs until end of October
Those documents now need to be reviewed by relevant stakeholders before being submitted to the committee, he said. After the Archives combs through all of the estimated 900,000 pages, more vetting would have to occur.

Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment.

"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", the FDA stressed. Thus, the full extent of the risks is unknown.

According to Scott Gottlieb, many manufacturers have marketed their devices as being useful in "vaginal rejuvenation" (a procedure that usually destroys or reshapes the tissue). 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. The agency is requesting the companies to address their concerns within one month. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.

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".

According to CNBC, the American College of Obstetricians and Gynecologists recommends "doctors inform patients about the lack of data supporting the efficacy and potential complications of vaginal rejuvenation and other similar procedures". We will keep the public informed if significant new information becomes available. They advised healthcare providers to report any adverse effects of such unapproved procedures to the FDA Safety Information and Adverse Event Reporting program, MedWatch.

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