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Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions
1National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20892, USA. jill.brown@nih.gov
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.
Insights
Serious complications, including bowel injury and sepsis, can occur with minimally invasive endometrial ablation devices. Adhering to manufacturer instructions and proper training are crucial for patient safety.
Area of Science:
- Gynecology
- Medical Device Safety
- Public Health
Background:
- Minimally invasive endometrial ablation devices offer alternatives for managing abnormal uterine bleeding.
- Understanding the safety profile of these devices is essential for clinical practice.
Purpose of the Study:
- To review serious adverse events and off-label device use for FDA-approved minimally invasive endometrial ablation devices.
- To identify specific complications and their association with device usage.
Main Methods:
- Analysis of the FDA Manufacturer and User Facility Device Experience database (2005-2011).
- Inclusion of reports detailing device malfunction, patient injury, or death.
- Categorization of serious injuries and identification of off-label use instances.
Main Results:
- Significant rates of bowel injury (128), sepsis/bacteremia (47), and intra-abdominal abscess (18) were reported.
- Four deaths were associated with device use.
- Off-label use was cited in 8% of serious adverse events and higher percentages for hysterectomy and bowel resection reports.
Conclusions:
- Endometrial ablation devices carry risks of serious complications.
- Emphasis on correct device utilization and adherence to manufacturer guidelines is critical.
- Further vigilance and training are recommended to mitigate patient harm.
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