Adherence to protocols would cut injury risk in endometrial ablation.(Gynecology)

CHICAGO -- The risk of injury occurring during global endometrial ablation could be greatly reduced if physicians simply followed protocols, Dr. Howard T. Sharp said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

An analysis of 387 reports with 186 injuries in women who underwent global endometrial ablation showed that 24.2% (45/186) of overall complications and 36.5% (42/115) of all major injuries potentially could have been avoided by strict adherence to intraoperative protocols and technique.

A history of cesarean delivery, even via low transverse hysterotomy, also was identified as a potential risk factor.

Data were culled from the Food and Drug Administration's Manufacturer and User Facility Device Experiences (MAUDE) database from patients undergoing global endometrial ablation surgery via a wide range of techniques between January 1998 and April 2005.

Primary injuries found in these patients included genital tract burns (43), bowel burns (39), uterine perforation (33), infection (30), and uterine/cervical scarring (19).

The ratios of injuries to potentially avoidable injuries by method were microwave endometrial ablation 11/9 (82%), NovaSure (radiofrequency ablation) 35/12 (34%), Her Option (cryoablation) 12/1 (8%), hydrothermablation 33/10 (30%), and ThermaChoice (uterine balloon ablation) 95/18 (19%).

Reporting adverse events to the MAUDE database is mandatory for manufacturers of medical devices, but reporting these events is voluntary for providers.