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

To characterize adverse event reports involving bowel injury associated with NovaSure (Hologic, Marlborough, MA) endometrial ablation devices using the U.S. Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.

Reports were coded and tallied based on primary, secondary, and tertiary procedures, findings & complications, and interventions.

Retrospective study using the nationwide FDA MAUDE database.

Reports from January 2015 through February 2025, yielding 1912 device reports, 153 of which described bowel injuries.

Each report was reviewed for type and location of bowel injury, concurrent injuries, subsequent interventions, and outcomes.

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 largest proportion of patients returning within 24 hours (28.1%). Over the ten-year period, there was a decline in the absolute number of adverse reports involving any bowel injury per year, with a high of 28 reports in 2015 and a low of 6 reports in 2024.

Despite multiple built-in safety mechanisms-including operator training, cavity integrity assessment (CIA), impedance-controlled energy delivery, automated self-tests, and recent updates to integrated safety features, concerns regarding uterine and bowel injuries remain. Over a 10-year period, 153 bowel injuries were reported following NovaSure use; many requiring major surgical interventions such as bowel resection.