1447 FDA Notice on Transvaginal Energy-Based Devices (TV-EBD) for Laser Vaginal Therapy: Was it Justified?

ConclusionMany 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.
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research