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Vaginal Rejuvenation Treatments May Be Unsafe

On July 30, 2018, the United States Food & Drug Administration (FDA) issued a formal warning to manufacturers of laser gynecological devices and patients who have undergone, or plan to undergo, treatment with such devices. The FDA initially cleared these “energy based” devices for the treatment of serious health conditions, including cancer and hysterectomies. However, after reviewing reports of problems and the results of several studies, the agency has issued a stern warning against the use of these devices for “off label” purposes—including vaginal rejuvenation. Although these devices have been approved for the treatment of serious health conditions, the FDA has not approved their use for the treatment of other conditions for which they are being used. Seven device manufacturers have been targeted with warning letters, and the FDA has requested their feedback before deciding what actions, including potential enforcement actions, are appropriate.


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Lasers Being Promoted for “Vaginal Rejuvenation

In recent years, companies that manufacture these devices have begun to promote and market them for the off-label purpose of vaginal rejuvenation procedures. This procedure is intended to remedy conditions such as menopause, urinary incontinence, and problems with sexual function. The devices are also marketed for cosmetic purposes, and as a new approach to “women’s intimate helath,” even among a younger demographic. One company, BTL Industries, maintained an entire “pelvic-suite” webpage that touted the device as a means to build collagen and elasticity.

The American College of Obstetricians and Gynecologists (ACOG) has staunchly opposed the use of these devices for off label purposes. The organization has issued a number of statements intended to alert the public and treatment providers that these devices have not been approved by the FDA for the purposes for which they are frequently advertised.

FDA Issues Stern Warning to Manufacturers

The FDA has finally concurred with the ACOG’s warnings regarding these devices. According to Commissioner of the FDA, Dr. Scott Gottlieb, these laser and energy based devices come with serious risks. Dr. Gottlieb has voiced serious concerns about these devices based on the lack of research to support use of these devices for the treatments that they are being marketed for. According to the FDA, the full extent of the risks is unknown, but some reported complications include:
  • Vaginal burns
  • Burning sensation
  • Scarring
  • Long term pain
  • Chronic pain
  • Recurring pain
  • Pain during intercourse

The FDA has already received 14 reports of adverse incidents from the off-label use of these devices. However, this data is likely incomplete, considering that no federal agency or nonprofit medical group has specifically set out to collect data on adverse incidents that result from vaginal rejuvenation procedures. Despite these reports, manufacturers continue to put pressure on the agency to speed up approval of various types of medical devices that have not been subject to rigorous research and testing.

The FDA has issued warning letters to seven manufacturers, and will continue monitoring reports of adverse events associated with the use of these devices. The agency has also pledged to alert the public if and when material facts regarding the safety of these devices comes to its attention. These letters do not constitute a formal warning, though one may follow in the future. Manufacturers have been asked by the FDA to provide details on the products that they are putting into the market place, and the underlying basis for seeking FDA approval (presumably to prevent off-label usage).

FDA Issues Patient Advisory

In addition to warning manufacturers, the FDA is encouraging the public to report adverse effects following vaginal rejuvenation treatment via MedWatch, the FDA’s adverse incident reporting portal.

What Should Patients Do?

The FDA has specifically addressed the public, advising that the safety and effectiveness of cosmetic vaginal procedures has not yet been established. Even if purportedly administered by a health care provider for symptoms related to incontinence, sexual dysfunction, or menopause, these procedures may not be safe. You should fully address all risks of any procedure you are considering undergoing or have been advised to undergo with your treatment provider. If you have symptoms, there may be safer ways to address them that have been approved by the FDA. Anyone who has undergone cosmetic vaginal procedures with an energy-based device or laser is encouraged to report adverse effects to the FDA through its MedWatch portal.

Seven Manufacturers Warned by the FDA

The seven manufacturers that received warning letters from the FDA include:
  • Cynosure, Inc. Cynosure sells a laser system called MonaLisa Touch, which has been promoted for use in the treatment of menopause.
  • Alma Lasers. Alma’s FemiLift laser has been approved for “soft-tissue” treatment but has been marketed for cosmetic use.
  • BTL Industries. BTL manufactures the Exilis Ultra 360 System, which has been approved for the treatment of wrinkles and rhytids, but has been promoted for its alleged ability to increase collagen.
  • BTL Aesthetics. BTL manufactures the Venus Fiore RF Ablation system, which has been marked for a number of cosmetic procedures. The FDA has not approved use of this device for the stated purposes.
  • MD Ltd. The FormaV and FractoraV lasers have been promoted for the treatment of stress incontinence, among other cosmetic and health conditions.
  • JOULE Multi-Platform System and DiVa Laser Vaginal Therapy systems have been approved for general use, not for cosmetic vaginal therapy.
  • Thermigen, Inc. THERMIva has not been approved for use in vaginal rejuvenation procedures.

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Published on Aug-21-18


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