Concerns from the federal Food and Drug Administration (FDA) sired the first assessment of adverse events related to device-based procedures marketed for ‘vaginal rejuvenation,’ and the new analysis of the Manufacturer and User Facility Device Experience (MAUDE) database identified a total of 45 distinct events describing 46 patients as of January 2019.
The new study appears in Lasers in Surgery and Medicine and was selected as the April 2019 Editor’s Choice.
“After the FDA issued a statement in July 2018, there was significant concern over the marketing of lasers and energy-based devices to promote “vaginal rejuvenation,” writes study author Jusleen Ahluwalia, MD, a second-year dermatology resident at UC San Diego, in a news release. “Our study is important because it is the first assessment of adverse events related to procedures marketed for “vaginal rejuvenation” within the FDA-maintained registry.”
Based on the new adverse event reports, “vaginal rejuvenation” has been used for management of lichen sclerosis, vaginal dilation in a patient with Müllerian agenesis, vulvar or urethral pain, dyspareunia, urinary incontinence, and vaginal atrophy. The most commonly reported adverse event related to the procedure was pain (vaginal, bladder, urethral, or unspecified), followed by burning or numbness. The majority of patients sought medical care for their injuries, which included long-term pain, numbness, burning, bladder disturbances, infections, scarring, dyspareunia, worsening symptoms, aggravation of lichen sclerosis, and disfigurement.
“Currently, this study is the largest summary that describes adverse events related to this procedure, although its source is subject to verification bias. These events signify the importance of clinical trials that investigate the efficacy and safety profile of laser and energy-based devices for optimization of sexual function and treatment of genitourinary syndrome of menopause (GSM)-related symptoms,” Dr. Ahluwalia says. “In the near future, data-driven protocols with laser and energy-based alternatives will become available for treatment of GSM‐related symptoms, lichen sclerosis, pelvic floor dysfunction, among other indications, and will improve the quality of life for patients suffering from chronic disease.”