Published: Fri, August 03, 2018
Medical | By

FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

The FDA described the company's "pelvic-suite" webpage, where the device was advertised as able to build collagen and elasticity for "female intimate parts", and requested that the company furnish documentation that it had been cleared to market the product for such uses.

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women's health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for "vaginal rejuvenation" [news release]. These are in fact used by licensed gynaecologists.

The idea is that the vaginal rejuvenation process will help boost sexual desire and sexual function, but there's just one problem: These claims are probably all BS, says Dr. Gupta. However, a new warning from the Food and Drug Administration (FDA) has suggested women stay away from these procedures as they haven't yet been properly tested or approved by the FDA yet. IT could lead to numbness in the region as well as pain during urination and sexual intercourse, the FDA warned.

As per CNN, FDA in a statement said, "We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures".

According to the FDA, numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain have been reported and documented.

The companies targeted by the FDA on Monday were Inmode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; and Cynosure.

"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". Answers from the companies have been sought within the next 30 days.

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". "We are deeply concerned women are being harmed", says the FDA warning.

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

The administration said some of the procedures use lasers or "energy-based devices" to "destroy or reshape vaginal tissue".

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. There is little scientific basis for the use of these methods state the FDA.

Hologic, Inc., owner of Cynosure, replied to this with an email saying they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously". However such claims seem spurious says the FDA.

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