A new trend with potentially dangerous implications for women has been developing, according to the U.S. Food and Drug Administration (FDA).

The marketing of vaginal plastic surgery and other techniques to renew and “rejuvenate” the birth canal for problems secondary to childbirth and menopause has become commonplace, but the procedures may not be safe, says the agency.  Vaginal plastic surgery and rejuvenation techniques are done using tools the FDA approved for very specific gynecological purposes in ways outside of how they were intended.

According to Dr. Scott Gottlieb—head of the FDA—in an article posted at Mass Device, laser devices designed and approved to destroy tissues that are tested and found to be precancerous through biopsy, genital warts, and other abnormal tissue are being used to treat sexual dysfunction, urinary incontinence, and symptoms heralding the beginning of menopause.

These uses of laser and radio-frequency based tools in vaginal plastic surgery are being presented by several companies as an easy solution for everything from vaginal dryness—a common side effect of decreased estrogen as a women enters menopause—to low sex drive and painful intercourse.

After having been “sold” by the companies sponsoring this advertising that vaginal plastic surgery is relatively inexpensive and non-invasive, fairly healthy women are requesting vaginal plastic surgery and rejuvenation procedures that have not been fully reviewed by the FDA.

Reports of Complications

FDA’s Gottlieb has done an extensive review, according to the article, of side effect reports registered with FAERS, the FDA’s Adverse Event Reporting System. He has discovered numerous cases where women complain that vaginal plastic surgery left them with birth canal burns, tissue scarring, chronic or pain flares in the genital region, and continued or new pain with sexual intercourse.

Women should beware and know the names of the companies involved in these promotions. Women should also be sure to seek appropriate care for gynecological issues they may be experiencing. Here are some of the business names allegedly involved in deceptively marketing vaginal plastic surgery and rejuvenation techniques using laser and radio frequency-based tools:

• Venus Concept
• BTL Industries
• Cynosure
• Alma Lasers
• Sciton
• Thermigen
• Inmode MD

The FDA Issues a Warning

On July 30, 2018, the FDA issued a formal warning to physicians and the public regarding the developing vaginal plastic surgery trend. The warning states that the safety and effectiveness of these devices as used in so-called vaginal rejuvenation procedures has not been studied or established by the drug and device governance agency.

The warning refers to “vaginal rejuvenation” as a coined term with imprecise and vague meaning and encourages doctors to query their patients regarding the range of symptomology, motivations, and treatment options should they express a desire to undergo such procedures.

To date, there have been no lawsuits filed against the companies offering these treatments. If you or a loved one has had a treatment, however, and experienced unanticipated and painful side effects and complications, you or they could qualify to participate in a lawsuit investigation that is underway. Please fill out our form to request an initial consultation.