Obstetrics & Gynecology

Skip Navigation LinksHome > October 2012 - Volume 120 - Issue 4 > Minimally Invasive Endometrial Ablation Device Complications...
Obstetrics & Gynecology:
doi: 10.1097/AOG.0b013e31826af4fe
Original Research

Minimally Invasive Endometrial Ablation Device Complications and Use Outside of the Manufacturers' Instructions

Brown, Jill MD, MPH; Blank, Ken MD

Collapse Box

Abstract

OBJECTIVE: To review the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience database for reports describing serious adverse events and adverse events reports describing use outside of the manufacturers' labeled instructions for the five FDA-approved minimally invasive endometrial ablation devices.

METHODS: We queried the Manufacturer and User Facility Device Experience database for reports of device malfunction, patient injury, or death reported for each device from January 1, 2005 to December 31, 2011. We reviewed U.S. reports individually for annotations of patient injury or death and tabulated the reports by type of injury and device. We identified nine categories of serious injury (death, sepsis or bacteremia, intra-abdominal abscess, uterine rupture, thermal bowel injury, mechanical bowel injury, transmural uterine thermal injury, urologic injury, and lower genital tract or skin burns) and noted all reports citing device use outside of the manufacturers' labeled instructions. We also identified reports of hysterectomy or bowel resection attributable to an adverse event.

RESULTS: Serious adverse events, including bowel injury (n=128), sepsis or bacteremia (n=47), intra-abdominal abscess (n=18), urologic injury (n=2), and uterine rupture (n=1) were reported. Death was also reported (n=4). Eight percent (66 of 829) of serious adverse events reports cited use outside of the manufacturers' labeled instructions, as did 7.3% (6 of 82) of reports citing need for hysterectomy and 8.7% (9 of 103) of reports of bowel resection.

CONCLUSION: The findings from the Manufacturer and User Facility Device Experience database highlight the potential risk of serious complications related to endometrial ablation and underscore the importance of training in correct device use and familiarity with the manufacturer's labeled instructions.

LEVEL OF EVIDENCE: III

© 2012 The American College of Obstetricians and Gynecologists

Login

 

Looking for ABOG articles? Visit our ABOG MOC II collection. The selected Green Journal articles are free through the end of the calendar year.

ACOG MEMBER SUBSCRIPTION ACCESS

If you are an ACOG Fellow and have not logged in or registered to Obstetrics & Gynecology, please follow these step-by-step instructions to access journal content with your member subscription.

Article Tools

Share

Article Level Metrics