Open Hysterectomies More Deadly Than Power Morcellation, Says AAGL

August 19, 2014

Eradicating morcellators is riskier than using them, says the AAGL in a statement for why these minimally invasive devices should not be abandoned.

[[{"type":"media","view_mode":"media_crop","fid":"27146","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_649710989091","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2608","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"line-height: 1.538em; float: right;","title":"Jubilee Brown, MD","typeof":"foaf:Image"}}]]The American Association of Gynecologic Laparoscopists' (AAGL) Board of Trustees member Jubilee Brown, MD, has issued a statement on behalf of the organization regarding its position that laparoscopic power morcellation for uterus removal is a beneficial procedure that should be improved upon rather than abandoned.

According to the statement, of the approximate 600,000 hysterectomies performed each year in the United States, about 63% involve minimally invasive surgery. Minimally invasive surgery has been shown to have a multitude of benefits compared with open surgery, such as decreased blood loss, transfusion, pulmonary complications, infections, and more.

However, minimally invasive surgery using power morcellation has recently come under scrutiny because of the risk of exposing the peritoneal cavity to an undetected uterine malignancy during morcellation, which is a procedure that divides uterine tissue into smaller pieces inside the peritoneal cavity, allowing for easier extraction.

Dr Brown’s statement was a summary of a presentation she made during an FDA Obstetrics and Gynecology Devices Advisory Committee held in July.

Safety Concerns

In April, the FDA issued a Safety Communication that discouraged the use of laparoscopic power morcellation for the removal of the uterus or uterine fibroids, citing an internal analysis that suggested that use of the devices increased risk for spreading unsuspected cancerous tissue.

In mid-July, the FDA Obstetrics and Gynecology Devices Advisory Committee held a two-day meeting during which it discussed the use of laparoscopic power morcellators and heard testimony from industry, patient advocates, patients, and physicians representing professional societies. No vote was taken, but the panel considered topics such as requiring informed consent and the possibility of putting a black box warning on morcellator devices advising of the potential for cancer and other risks associated with laparoscopic power morcellators.

AAGL Response

In its published statement, the AAGL acknowledged that the risk for undetected uterine malignancy in patient’s undergoing hysterectomy with power morcellation does exist but is generally low.

“Prevalence estimates are difficult to determine, as limited data exist, studies are small and retrospective, or of poor quality, and all data from which statistics are calculated are subject to publication bias,” the statement said.

The association cautioned against eliminating a “beneficial technology” based on imprecise data. In its view, the elimination of power morcellation would result in more women undergoing open hysterectomy, exposing patients to increased surgical risk.

The AAGL constructed a decision analysis model using available literature. Estimating the risk for leiomyosarcoma at 1:585, the model determined that the mortality from laparoscopic hysterectomy with power morcellation was 0.077%, compared with a mortality of 0.085% from open hysterectomy.

“Converting all hysterectomies currently undergoing power morcellation to open surgery would result in an annual increase of 17 more women dying from surgery each year, and a substantial increase in morbidity from open surgery,” the statement said.

References:

Brown J, regarding data by Naumann RW et al (submitted), presented to the Obstetrics and Gynecology Devices Panel of the FDA Medical Devices Advisory Committee, July 11, 2014. Available here: http://www.aagl.org/aaglnews/aagl-statement-to-the-fda-on-power-morcellation/.