INTRODUCTION: Radiofrequency endometrial ablation has been available since 2001 as a treatment for heavy menstrual bleeding in women without structural uterine anomalies who have completed childbearing. The most widely used device, NovaSure (Hologic, Marlborough, MA), is a global ablation system that employs an impedance-controlled array designed to uniformly ablate the endometrium. Despite multiple built-in safety mechanisms—including operator training, cavity integrity assessment, impedance-controlled energy delivery, and automated self-tests—concerns have persisted regarding bowel injury associated with radiofrequency global endometrial ablation. OBJECTIVE: To characterize adverse event reports involving bowel injury associated with NovaSure endometrial ablation devices using the FDA MAUDE database. METHODS: The FDA MAUDE database was queried for reports from January 2015 through February 2025, yielding 1,912 device reports. Of these, 153 described bowel injuries. Each report was reviewed for type and location of bowel injury, concurrent injuries, and subsequent interventions. Outcomes included the type of repair, the presence of additional complications, and the time to return for management of complications. RESULTS: Among 153 reports, 95 (62.1%) involved at least one thermal bowel injury, 47 (30.7%) described bowel perforation, and 44 (28.8%) documented unspecified bowel injury (including adhesions, erythema, or ileus). Surgical interventions included bowel resection in 74 (48.4%), anastomosis in 24 (15.7%), and other bowel repairs in 26 (17%). When specified, the small bowel was the most frequent site of injury. Additional injuries included 56 (36.6%) uterine thermal injuries, 62 (40.5%) uterine perforations, and 15 (9.8%) reports of unspecified uterine injury. In 57 reports where time to return for complication management was specified, approximately 14% of patients returned after one week of the initial procedure, with the majority returning within 24 hours (28.1%). Over the ten-year period, there was a decline in the number of adverse reports involving any bowl injury per year, with a high of 28 reports in 2015 and a low of 6 reports in 2024. Notably, in 2021, the Novasure device received updates to its cervical seal, including markings for placement accuracy, and added suction through the array. CONCLUSIONS: Over a 10-year period, 153 bowel injuries were reported following radiofrequency endometrial ablation with NovaSure, many requiring major surgical interventions such as bowel resection. Despite recent updates to integrated safety features, significant concerns remain with this widely used device.Figure 1Figure 2
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