H Fernandez1, G Legendre2, C Blein3, L Lamarsalle3, P Panel4. 1. AP-HP, Department of Obstetrics and Gynecology, Hôpital Bicêtre, 78 rue du Général Leclerc, Le Kremlin Bicêtre, 94270, France; CESP-INSERM U1018, 82 rue du Général Leclerc, Le Kremlin Bicêtre, 94276, France; Université Paris Sud, 63 rue Gabriel Péri, Le Kremlin Bicêtre, 94270, France. Electronic address: herve.fernandez@bct.aphp.fr. 2. AP-HP, Department of Obstetrics and Gynecology, Hôpital Bicêtre, 78 rue du Général Leclerc, Le Kremlin Bicêtre, 94270, France; Université Paris Sud, 63 rue Gabriel Péri, Le Kremlin Bicêtre, 94270, France. 3. Heva-Health Evaluation, 186 avenue Thiers, Lyon, France. 4. Department of Obstetrics and Gynecology, Centre Hospitalier de Versailles, Versailles, France.
Abstract
OBJECTIVE: To compare the rates of pregnancy among women who underwent Essure hysteroscopic sterilization versus tubal ligation in France between 2006 and 2010. STUDY DESIGN: Retrospective cohort study. SETTING: Hospital care in France (nationwide). Anonymised database of all hospital discharge summaries in France. PATIENTS: Recruitment was based on procedure codes in the national database of hospital discharge summaries. The study included all women who underwent tubal sterilization by Essure microinserts or by tubal ligation and subsequently were hospitalised either for all unexpected pregnancies related diagnosis (e.g., miscarriage, legal abortion, or delivery) or for pregnancies following reversal microsurgery or invitro fertilization (IVF) treatment. MEASUREMENTS AND MAIN RESULTS: During the study period, French hospitals performed 109,277 tubal sterilization procedures: 39,169 Essure sterilizations and 70,108 laparoscopic tubal ligations. The respective indication of both techniques depended on the surgeons' skill. The median age of the two populations was similar, 41 years (range 28-52) for Essure patients and 40 years (range 27-54) for those undergoing tubal ligation (p=0.42). A Cox model has been performed. Following sterilization, after adjustment on age Essure patients became pregnant at a significantly lower rate than laparoscopic ligation patients 0.36% versus 0.46%, respectively (HR=0.62 (040-096)), and their pregnancy rate of post-sterilization procedure was significantly lower (reversal microsurgeries: 0.02% versus 0.19% (p<0.001), IVF treatment: 0.08% versus 0.27%) (p<0.001). The pregnancy rates after IVF were 12.5% and 5.35%, respectively, and 0% and 11.36% after tubal repair. CONCLUSION: This nationwide study of tubal sterilization demonstrates that Essure was associated with lower rates of pregnancy versus tubal ligation.
OBJECTIVE: To compare the rates of pregnancy among women who underwent Essure hysteroscopic sterilization versus tubal ligation in France between 2006 and 2010. STUDY DESIGN: Retrospective cohort study. SETTING: Hospital care in France (nationwide). Anonymised database of all hospital discharge summaries in France. PATIENTS: Recruitment was based on procedure codes in the national database of hospital discharge summaries. The study included all women who underwent tubal sterilization by Essure microinserts or by tubal ligation and subsequently were hospitalised either for all unexpected pregnancies related diagnosis (e.g., miscarriage, legal abortion, or delivery) or for pregnancies following reversal microsurgery or invitro fertilization (IVF) treatment. MEASUREMENTS AND MAIN RESULTS: During the study period, French hospitals performed 109,277 tubal sterilization procedures: 39,169 Essure sterilizations and 70,108 laparoscopic tubal ligations. The respective indication of both techniques depended on the surgeons' skill. The median age of the two populations was similar, 41 years (range 28-52) for Essure patients and 40 years (range 27-54) for those undergoing tubal ligation (p=0.42). A Cox model has been performed. Following sterilization, after adjustment on age Essure patients became pregnant at a significantly lower rate than laparoscopic ligation patients 0.36% versus 0.46%, respectively (HR=0.62 (040-096)), and their pregnancy rate of post-sterilization procedure was significantly lower (reversal microsurgeries: 0.02% versus 0.19% (p<0.001), IVF treatment: 0.08% versus 0.27%) (p<0.001). The pregnancy rates after IVF were 12.5% and 5.35%, respectively, and 0% and 11.36% after tubal repair. CONCLUSION: This nationwide study of tubal sterilization demonstrates that Essure was associated with lower rates of pregnancy versus tubal ligation.