Safety and patients’ satisfaction after hysteroscopic sterilisation

Abstract

The aim of this study was to understand the potential complications of the Essure^® device as well as the factors influencing its onset and patient satisfaction. We present a 9-year descriptive prospective study that included 1068 patients. The device was placed in 1056 of them (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p = .00). In all, 161 of the 1064 patients who had the Essure^® inserted reported having an adverse effect during the 3-months post-insertion (pelvic pain or discomfort). The mean score out of 10 attributed to this method was 9.06 (S = 1.11). We concluded that the Essure^® shows a low rate of complications and users showed a high degree of satisfaction.

Impact statement

• What is already known on this subject: There are few international publications on Essure^®. When we conducted a search in PubMed for the term ‘Essure’, we obtained 221 publications. When we added the terms ‘Essure and complications’, we obtained 20 publications, and when we increased the restriction including ‘satisfaction’, we obtained seven; thus, the uniqueness of our study.

• What the results of this study add: We present a 9-year descriptive prospective study that included 1068 patients. The aim of this study was to understand the potential complications of the Essure^® device (Bayer, Whippany, NJ), as well as factors that can influence its onset and the patient satisfaction. The device was placed in 1056 of the patients (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p=.00).

• What the implications are of these findings for clinical practice and/or further research: Our study shows a low rate of complications with Essure^®, mild and transient in most cases, as well as a high degree satisfaction. Nevertheless, given the few published studies on this device, we believe that long-term follow-up is needed.

Keywords:

• Essure^®
• tubal sterilisation
• histeroscopy
• contraception
• adverse events
• complications

Disclosure statement

The authors report no declarations of interest.

Acknowledgements

The authors wish to thank all the staff of the Hysteroscopy Unit of ‘Virgen de la Macarena’ University Hospital of Seville, Spain, for their support to this study.