LAUSR

Study Objective Our aim in this study was to shed light on the origin of evidence for reported adverse events detailed in the Manufacturer and User Facility Device Experience (MAUDE) given by the FDA communication regarding the use of laser vaginal device therapy. Design The MAUDE database was queried from 2010-2018 for adverse events related to manufacturers who currently offer laser vaginal therapy devices. Each adverse event was then categorized based on the details of the event as device error, provider error, a common risk, patient-reported lack of efficacy, or a procedure related adverse event. Additionally, social media outlets such as Twitter were reviewed to gather public opinion on laser vaginal therapy in response to the recent FDA communication. Setting N/A. Patients or Participants N/A. Interventions N/A. Measurements and Main Results A total of 40 adverse events were reported on the MAUDE database regarding laser vaginal therapy devices in the queried time frame. Of that 40, 27 were unique events, while the other 13 were duplicate reports. Of the 27, 12 were categorized as patient-reported lack of efficacy, 8 were provider error, 3 were device error, 2 were common risk, and 2 were, with the provided information in MAUDE, procedure related AEs. Social media responses revealed largely negative opinions on laser vaginal therapy devices. Conclusion Many of the reported adverse events on the MAUDE database revealed a fundamental lack of education, either to the providers, or to the patients, on the efficacy of laser vaginal therapy. Almost half of the total individual reports to MAUDE (12) were patients with previous medical histories regarding vaginal dryness, incontinence or sexual dysfunction reporting continued lack of improvement. These reports support the concern of miscommunication with device manufacturer. As with any medical treatment, in-depth consultation with a professional help reduce any procedural risk.