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Complications Associated With Global Endometrial Ablation: The Utility of the MAUDE Database

From the Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah.

Address reprint requests to: Shawn E. Gurtcheff, MD, University of Utah School of Medicine, Department of Obstetrics and Gynecology, Room 2B200, 30 North 1900 East, Salt Lake City, UT 84132; E-mail: shawn.gurtcheff{at}hsc.utah.edu.

OBJECTIVE: To investigate the number and type of complications associated with global endometrial ablation using public-access governmental databanks.

METHODS: MEDLINE (PubMed) and the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) databases were searched for entries for the four US Food and Drug Administration–approved global endometrial ablation devices.

RESULTS: Traditional MEDLINE and bibliography searches yielded reports of two cases of hemorrhage, one case of pelvic inflammatory disease, 20 cases of endometritis, two cases of first-degree skin burns, nine cases of hematometra, and 16 cases of vaginitis and/or cystitis. A search of the US Food and Drug Administration MAUDE database yielded reports of 85 complications in 62 patients. These included major complications: eight cases of thermal bowel injury, 30 cases of uterine perforation, 12 cases in which emergent laparotomy was required, and three intensive care unit admissions. One patient developed necrotizing fasciitis and eventually underwent vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee amputations. One of the patients with thermal injury to the bowel died.

CONCLUSION: Use of the US Food and Drug Administration MAUDE database is helpful in identifying serious complications associated with global endometrial ablation not yet reported in the medical literature.

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