Predictive factors of Essure implant placement failure: prospective, multicenter study of 495 patients.
OBJECTIVE
To assess a new hysteroscopic method of tubal sterilization; specifically, to examine the factors associated with placement failure of Essure implants.


METHODS
Observational, multicenter, 6-month study.


METHODS
Seven gynecology clinics, including five public hospitals and two private clinics, in France.


METHODS
A total of 495 women who provided informed consent.


METHODS
All procedures were done by a vaginoscopic approach with a 5-mm operating hysteroscope.


METHODS
Data collected were age, parity, type of anesthesia, premedication, endometrial aspect, ostia visualization, duration of the procedure, pain during the procedure, and associated procedures. Unilateral and bilateral placement rates were assessed. Adverse events at 3 months (expulsion, migration, perforation) were also recorded.


RESULTS
Mean parity was 2.45; 20 women were nulliparous. In 56.3% of cases (n = 277), none or local anesthesia was used for the placement procedure. Overall, 86% of the women (n = 423) had nonsteroidal anti-inflammatory drug (NSAID) premedication, and 8.1% (n = 40) had another intrauterine surgical procedure performed at the same time. In 24 cases, at least one of the tubal ostia could not be visualized well during hysteroscopy.


CONCLUSIONS
The failure rate for Essure micro-insert placement was 6% at first attempt and 3.3% after two attempts. Success rate was not significantly associated with parity, mode of analgesia, NSAID premedication, or combination with another procedure. The only factor significantly associated with the failure rate was poor visualization of the tubal ostia.
Panel
Pierre
P
Service de Gynécologie-Obstétrique, Centre Hospitalier de Versailles, Le Chesnay, France. ppanel@ch-versailles.fr
Grosdemouge
Isabelle
I
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D004867:Equipment Design; D004868:Equipment Failure; D005187:Fallopian Tubes / Q000293:injuries; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology; D005602:France; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects*; D007433:Intrauterine Device Expulsion / Q000209:etiology; D007434:Intrauterine Devices / Q000009:adverse effects*; D008875:Middle Aged; D016017:Odds Ratio; D010298:Parity; D011247:Pregnancy; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013246:Sterilization, Tubal / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors; D017211:Treatment Failure
D000894:Anti-Inflammatory Agents, Non-Steroidal