Analysis of Reported Adverse Events with Uterine Artery Embolization for Leiomyomas

Study Objective

To analyze and investigate reports associated with uterine artery embolization used for treatment of myomas using this database.

Design

A retrospective review of the Manufacturer and User Facility Device Experience (MAUDE) database for events related to uterine artery embolization (Canadian Task Force Classification III).

Setting

The MAUDE database was accessed online.

Patients

Patients with myomas undergoing uterine artery embolization.

Interventions

The MAUDE database was accessed online and searched for events related to uterine artery embolization reported between 1998 and 2018. These reports were reviewed and analyzed, reported events were categorized, and other relevant information was collected and tabulated.

Measurements and Main Results

A total of 193 reports published during the study period were identified. Pain was the most frequently reported event (68 events; 35.2%), followed by vaginal discharge (45 events; 23.3%), operational misfire (37 events; 19.2%), and fever or infectious complications (36 events; 18.7%). A surgical procedure was required in 27 events (14.0%), with hysterectomy reported in 7.8% of the events. Death following this procedure was mentioned in 5 events (2.6%).

Conclusion

The MAUDE database may be useful for clinicians using a Food and Drug Administration–approved medical device to identify the occurrence of adverse events and complications. A variety of adverse events associated with the use of uterine artery embolization were reported to the MAUDE database related to its use in the treatment of uterine myomas. We encourage physicians to review the MAUDE database when using medical devices, because this is an important tool to assess uncommon but major problems that could be associated with a medical device.