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Concerns from the FDA start the first assessment of adverse events related to device procedures marketed for “vaginal rejuvenation”

This study shows the importance of clinical trials that investigate the efficacy and safety profile of laser and energy-based devices.

By Emilee Green | Apr 25, 2019

lsm-ec-ahluwaliaWausau, WI (April 25, 2019) – Each year, the FDA receives medical device reports that describe device-associated injuries through the publicly available Manufacturer and User Facility Device Experience (MAUDE) database. The FDA uses these reports to identify potential safety issues as a result of device use. This analysis is designed to summarize adverse events related to procedures involving “vaginal rejuvenation” within the MAUDE database. This study identified a total of 45 distinct events describing 46 patients as of January 2019.

The clinical report of this study, published in Lasers in Surgery and Medicine (LSM), the official journal of the American Society for Laser Medicine and Surgery, Inc. (ASLMS), was selected as the April 2019 Editor’s Choice.

The study, led by Jusleen Ahluwalia, MD is titled “Lasers and energy-based devices marketed for vaginal rejuvenation: A cross-sectional analysis of the MAUDE database.”

“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.” In their statement, the FDA mentioned that they found numerous cases of adverse events based on reports and published literature. 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,” said Ahluwalia.

Based on the 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,” said Ahluwalia. ”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.”

Dr. Jusleen Ahluwalia is a second-year dermatology resident at UC San Diego. She serves the American Society for Laser Medicine and Surgery (ASLMS) as a Resident/Fellow Board Representative. Her research focuses on investigating lasers and energy-based devices for the treatment of skin cancer and melasma.

Editor’s Choice is an exclusive article published in LSM, the official journal of the ASLMS. View the complete manuscript.

The American Society for Laser Medicine and Surgery, Inc. (ASLMS) is the largest multi-disciplinary professional organization, dedicated to the development and application of lasers and related technology for health care applications. ASLMS promotes excellence in patient care by advancing biomedical application of lasers and other related technologies worldwide. ASLMS membership includes physicians and surgeons representing multiple specialties, physicists involved in product development, biomedical engineers, biologists, nurses, industry representatives and manufacturers. For more information, visit aslms.org.

The American Society for Laser Medicine and Surgery is the world’s largest scientific organization dedicated to promoting research, education and high standards of clinical care in the field of medical laser applications. It provides a forum for the exchange of scientific information and participation in communicating the latest developments in laser medicine and surgery to clinicians, research investigators, government and regulatory agencies, and the public.

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