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.
The reporting requirement could result in some duplication, but it's more likely injuries are underreported, in part because of fear of potential litigation, said Dr. Sharp of the University of Utah, Salt Lake City.
“Everyone is worried about it,” he said. “The key thing is to be worried about patient safety, which is why a checklist is so important.”
He suggested that physicians adopt a checklist similar to ones used by pilots, to make sure procedures are being performed in the appropriate patients and to stay within manufacturers' recommendations.
Physicians also should consider using saline infusion sonography in patients with a history of cesarean section, provide adequate anesthesia, recognize that two ablations at the same setting are not better than one, avoid modifying the device or surgery, and have an exit strategy should complications arise, he said.
In a separate presentation on the same topic, Dr. Carl Della Badia and Dr. Ata Atogho of Drexel University College of Medicine, Philadelphia, concurred that the majority of serious adverse events occur when endometrial devices are used outside of the manufacturers' recommendations.
But they also concluded that the MAUDE database shouldn't be used to determine the safety of a particular ablation device because not all cases are reported, information is sketchy, and the database doesn't take into account that some devices are more widely used than others.
In addition, several device modifications are underway or have recently been made that could have an impact on outcomes, Dr. Della Badia said.
Improvements include a new tenacula for the hydrothermablation device, a new balloon for the ThermaChoice device, and a smaller probe with a new cervical stop for the microwave endometrial ablation system.