TY - JOUR
T1 - Hysteroscopic Essure Inserts for Permanent Contraception
T2 - Extended Follow-Up Results of a Phase III Multicenter International Study
AU - Chudnoff, Scott G.
AU - Nichols, John E.
AU - Levie, Mark
N1 - Funding Information:
We that the Selective Tubal Occlusion Procedure 2000 Investigators Group, which was integral to the conduct and publication of the Phase III trial with Essure: Jay M. Cooper, MD, Micah Harris, MD, and David Greenspan, MD, Women's Health Research, Phoenix, AZ; John F. Kerin, Reproductive Medicine Unit, University of Adelaide and Ashford Hospital, SA, Australia; David Levine, MD, Chesterfield, MO; Thomas Price, MD and John Nichols, MD, Reproductive Endocrinology, Greenville, SC; Enrique Cayuela-Font, MD, Department of Obstetrics and Gynecology, Institut Universitari Parc Taulf, Hospital de Sabadell, Spain; David Rosen, MD, Geoffrey Reid, MD, and Edith Weisberg, MD, Family Planning of New South Wales, Ashfield, NSW, Australia; Rafael F. Valle, MD, Section of Gynecology and Gynecology Surgery, Northwestern University, Chicago, IL; Donald I. Galen, MD, Reproductive Science Center of the Bay Area, San Ramon, CA; Linda D. Bradley, MD, Cleveland Clinic Foundation, Cleveland, OH; Harold I. Daily, MD and Gene Huebner, MD, Houston, TX; Bruno J. Van Herendael, MD, Jan Palfjin General Hospital, Merksem, Belgium; Sean R. G. Duffy, MD and Lynn Rogerson, MD, St James's University Hospital, Leeds, UK; and Susan A. Ballagh, MD, Jones Institute for Reproductive Medicine, Norfolk, VA. We also thank Daniel Cher, MD, Wild Iris Consulting LLC, Palo Alto, CA for his role in analyzing the study results. Editorial support in the form of manuscript writing (outline and first draft), styling, and submission was provided by Kevin Jarvis, PharmD, from BioCentric, Inc., funded by Bayer HealthCare AG .
Publisher Copyright:
© 2015 AAGL.
PY - 2015
Y1 - 2015
N2 - Objective: To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. Design: Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). Setting: Thirteen clinical study centers in the United States, Europe, and Australia. Patients: A total of 518 previously fertile women seeking permanent contraception. Intervention: The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. Measurements and Main Results: The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during follow-up as being "possibly" related to the procedure or the inserts. Conclusion: The findings from extended follow-up of this Phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional option for permanent contraception.
AB - Objective: To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. Design: Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). Setting: Thirteen clinical study centers in the United States, Europe, and Australia. Patients: A total of 518 previously fertile women seeking permanent contraception. Intervention: The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. Measurements and Main Results: The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during follow-up as being "possibly" related to the procedure or the inserts. Conclusion: The findings from extended follow-up of this Phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional option for permanent contraception.
KW - Essure insert
KW - Hysteroscopic sterilization
KW - Permanent contraception
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U2 - 10.1016/j.jmig.2015.04.017
DO - 10.1016/j.jmig.2015.04.017
M3 - Article
C2 - 25917278
AN - SCOPUS:84953366207
SN - 1553-4650
VL - 22
SP - 951
EP - 960
JO - Journal of the American Association of Gynecologic Laparoscopists
JF - Journal of the American Association of Gynecologic Laparoscopists
IS - 6
ER -