Food and Drug Administration Database Secondary Analysis: Difference in Operative Hysteroscopy Device Safety Profiles

Abstract

Study Objective

This study compared adverse event reports (AEs) amongst commonly used operative hysteroscopy devices.

Design

A secondary analysis of the Manufacturer and User Facility Device Experience (MAUDE)-a voluntary reporting system by the Food and Drug Administration. Search terms included “resectoscope,” “hysteroscopic reciprocating morcellator”, "MyoSure,” and “TruClear.” Statistical analysis utilized Chi-squared tests.

Setting

N/A.

Patients or Participants

Between 2014-present, 1872 AEs were identified for hysteroscopes: 664 for resectoscopes and 1208 for morcellation devices (MyoSure, N=645 and TruClear, N=563).

Interventions

N/A.

Measurements and Main Results

MyoSure and TruClear device AEs were combined into a “morcellation device” composite group and compared to resectoscope AEs. There were significant differences in patient complications: morcellation devices had higher rates of infection (p=0.0019), hemorrhage (p<0.00001), burns (p<0.00001), uterine perforation (p<0.00001), and bowel perforation (p<0.00001). Morcellation device AEs more often reported surgical intervention: hysterectomy (0.2 vs 3.0%, p<0.001), laparoscopy/laparotomy (0.9 vs 8.5%, p<0.001). Subgroup analysis comparing morcellation devices showed the majority (73.18%) of TruClear AEs reported no direct patient impact or harm, while only 21.2% of MyoSure AEs reported no patient impact. Compared to TruClear devices, MyoSure devices reported more infections (p=0.0012), hemorrhage (<0.00001), uterine perforations (<0.00001), and bowel perforations (p<0.00001). Additionally, MyoSure AEs reported more surgical intervention, including hysterectomy (4.8 vs 0.9%, p=0.00007) and laparoscopy/laparotomy (13.5 vs 2.8%, p<0.0001), comparatively. Though death is a rare complication of hysteroscopy, of 21 deaths reported, 17 were associated with MyoSure devices.

Conclusion

Significant differences in AEs exist among operative hysteroscopy instruments. Morcellation AEs comprised significant and substantial patient impact and surgical interventions compared to resectoscopes. When comparing Myosure and Truclear, MyoSure had significantly more serious patient complications (uterine/bowel perforation, infection, hemorrhage) compared to TruClear device AEs. It is vital for physicians to recognize associated risks and understand that devices with similar functions may differ significantly in safety profiles.