Introduction

The FDA recently announced actions to provide information about the risks of using the Essure device, requiring a mandatory postmarket study to determine its heightened risks. In this study, we aim to look at our experience with the Essure device and analyze its outcomes and complications, focusing on pelvic pain and the risks associated with re-operation.

Methods

We conducted a retrospective cohort study of 319 patient who underwent Essure placement between 2002 and 2016. Patient characteristics included age, race, BMI, parity, history of chronic pelvic pain, prior gynecological surgery or pelvic infec- tions, and documented nickel allergies. Measured outcomes included new or worsening pelvic pain, need for device removal or subsequent pelvic surgery. Logistic regression models were used to test the association between each predictor variable and measured outcomes.

Results

Out of the total patients, 64 had undergone re-operation and 255 did not. Most common procedure was hysterectomy with bilateral salpingectomy (6.58%) followed by endometrial ablation (5.96%), 3.3% of patients underwent Essure removal. The average time between Essure placement and re-operation was 9 years. Only 4.39% of re-operation were performed due to pelvic pain. There was a significant correlation between incidence of re-operation and illicit drug use (p 0.026), and prior gynecological surgery (p 0.008).

Conclusion

We re-demonstrate the rarity of new onset pelvic pain after Essure placement. However, illicit drug use, especially marijuana, and prior pelvic surgery were significant risk factors in re- operation following Essure placement and should be considered as part of the consent process.