Monday, November 18th, 2019
Home >> Med Devices >> Vag Rejuvenation: Fact or Fiction?

Women as Guinea Pigs in Vag Rejuvenation Medical Devices

Never forget for one minute that medicine is a business.

The latest sales pitch preys on a woman’s insecurities.

The pitch implies that she may be a less than ideal woman unless she undergoes “vaginal rejuvenation” a procedure using lasers to tighten things up”down there” to return to a more youthful time. 

Problem is none of the devices used for this process have received U.S. Food and Drug Administration (FDA) clearance and the federal agency is warning consumers to be aware of their dangers.

“Vaginal Rejuvenation,” is a fairly new term to describe non-surgical procedures that may treat vaginal symptoms that can accompany menopause.

Symptoms may include vaginal laxity, atrophy, decreased sexual sensation, pain during intercourse, or during urination. 

The pitch buzzwords are, “designer vaginoplasty,”  “revirgination,” and G-Spot amplification.”

Revirgination may involve repairing the hymen.  G-Spot amplification involves injecting collagen into the anterior wall of the vagina.  Designer vaginoplasty can involve altering the shape of the labia.

One ad for MonaLisa Touch, made by CynSure of Westford, Mass. is a popular treatment featuring senior women who recommend the therapy as it improved their sex life.

The procedure is said to take less than five minutes.

Women treated for breast cancer are also receiving the pitch because their treatment can bring on early menopause and in some cases they may not be able to use hormonal replacement therapy.

The energy-based devices, such as lasers or those employing radiofrequency, promise to stimulate tissue to make it more elastic, firm and lubricated.

FDA Commissioner Scott Gottlieb, M.D. issued a strong statement July 30, 2018.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” Gottlieb warns, adding: “We are deeply concerned women are being harmed.”

The FDA has not cleared any energy-based medical devices for “vaginal rejuvenation” or a vaginal cosmetic procedure which Dr. Gottlieb calls deceptive marketing practices “egregious.”

Published report say bleeding or a burning sensation can last more than three days after the procedure.  The agency has received two adverse event reports from manufacturers after patients experienced pain and bleeding.  Patient reports state pain and discomfort after the procedures.

The American College of Obstetricians and Gynecologists (ACOG) in a Committee Opinion from 2017 says, “These procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented.”

ACOG encourages doctors to talk to their patients about the need for such procedures. Women should receive true informed consent about the potential complications which can include infection, burns, dyspareunia (painful sex), altered sensation, scarring and adhesions.

ACOG in its May 2016 position statement says the fractional carbon dioxide (CO2) laser made by DEKA Smart Xide Co2, has been cleared through the 510(K) for use in plastic and general surgery, but not for the treatment of vulvovaginal atrophy.

The same warning applies to the YAG Laser System, cleared by the FDA for general surgery and dermatology, but not for the treatment of any vaginal atrophy.

The medical society says that observational data exists only and there have been no randomized trials to indicate safety and effectiveness. 

The FDA has sent warning letters to companies promoting these devices for vaginal rejuvenation to cease marketing the devices. Letters are the first step to what could result in a mandatory recall or product seizure.

Seven companies received letters including Thermigen, Sciton, InMode, Cynosure, BTL Industries, BTL Aesthetics and Alma Lasers.

The FDA has cleared lasers and energy-based devices for vaginal surgeries such as treating pre-cancerous cervical or vaginal tissue as well as genital warts.

Patients who experience any pain, burns, scarring and pain during intercourse, are urged to report their symptoms to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.   ###





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