On July 30th, 2018 the US Food and Drug Administration (FDA) issued a warning about Laser Devices for Vaginal Rejuvenation  citing the following:

Energy-based devices – commonly radiofrequency or laser – have received FDA clearance for general gynecologic tool indications, including, but not limited to, the destruction of abnormal or pre-cancerous cervical or vaginal tissue and condylomas (genital warts). However, 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. In other words, the FDA has cleared laser and energy-based devices to treat gynecologic conditions, but the safety and effectiveness of these devices have not been evaluated or confirmed by the FDA for “vaginal rejuvenation”.

The warning goes on to state that certain device manufacturers  have engaged in deceptive marketing and the FDA has been made aware of “numerous reports” of injury resulting from the use of some devices. The FDA has cited seven device manufacturers for inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are Alma Lasers (FemiLift), BTL Industries and BTL Aesthetics (EMSSELA), Cynosure (MonaLisa Touch), InMode (Votiva), Sciton (diVa), and ThermiGen (THERMIva).  The companies have 30 days to address the FDA’s concerns. 

What does this mean for clients of Advanced Laser Clinics of Shreveport (ALCS)?

ALCS currently offers vaginal and vulvar health promotion procedures utilizing the CO2RE LASER system by Syneron/Candela (not cited in the FDA warning). ALCS utilizes the device as one tool in an armamentarium for a comprehensive vulvovaginal health regimen.

Apart from one medical aesthetician, ALCS is staffed by gynecologists and women’s health nurse practitioners. Experienced and trained in medical aesthetics and lasers, the ALCS staff is specialty trained to address issues of the female reproductive system and genital tract. Our women’s health nurse practitioners are involved in screening, pre-treatment consultation, and post-treatment care of our vulvovaginal procedure clients. After conducting an examination to confirm the appropriateness of treatment, it is our Board-Certified Gynecologists who perform the laser treatment according to defined protocols.  

Are vulvovaginal health promoting procedures offered by ALCS safe?

Treatments ACLS provide for vulvovaginal health are safe. Though many LASERs have FDA approval for use in gynecology (including CO2RE), “Vaginal Rejuvenation” has not been FDA cleared. Numerous studies have shown efficacy and safety, but more peer reviewed studies are required for submission to the FDA to gain approval for this specific indication. The American College of Obstetricians and Gynecologists (ACOG) reinforces this need in its position paper on the topic:

Although initial data indicate potential utility, additional data clearly are needed to further assess the efficacy and safety of this procedure in treating vulvovaginal atrophy, particularly for long-term benefit.

More studies are ongoing. Since January 2018, Syneron/Candela (the manufacturer of CO2RE) has engaged with the FDA in efforts to expand CO2RE’s indications to vaginal and vulvar treatments in addition to the currently approved indications related to Women’s Health. On August 3rd, 2018, Syneron/Candela reported in a Customer Bulletin:

We believe in rigorous clinical study designs to allow the FDA to evaluate the safety and efficacy of future indications. We will work closely with the agency to ensure our study designs for all new indications meet the FDA’s criteria.

The FDA does not regulate the practice of medicine. As a result, many medications and medical devices are used “off label.” Off label use refers to the prescribing of drugs or the use of medical devices in ways that have not been approved by the FDA. Off Label use of medications and medical devices is very common in medicine. A good example is the use of aspirin to protect against heart disease in high-risk patients. Many other examples of off label use exists, often having become widely entrenched in medical practice, even becoming the standard of care.

At ALCS, we believe healthcare providers should provide safe treatments for indications that are in the best interest of their client. We will continue to keep you apprised of the latest developments regarding this matter and will continue providing exceptional care to our clients utilizing safe and effective tools that are available to us.