Bowel Injuries Reported After NovaSure® Endometrial Ablation: A 10-Year Review of FDA MAUDE Data

The authors aimed to characterize adverse events related to bowel injuries associated with NovaSure® endometrial ablation devices by analyzing data from the FDA's MAUDE database over a ten-year period. They found 153 reports of bowel injuries, with a significant proportion requiring major surgical interventions, despite the presence of safety mechanisms designed to prevent such complications. The study highlights ongoing concerns regarding the safety of the NovaSure® device, particularly in relation to bowel and uterine injuries.