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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Essure/post-NovaSure PAS


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General
Study Status Completed
Application Number P020014 S017/ PAS001
Date Current Protocol Accepted 09/29/2016
Study Name Essure/post-NovaSure PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Single-arm multi-center prospective observational study
Study Population Description Women aged 21-50 with Essure micro inserts properly placed (confirmatory hysterosalpingogram) seeking treatment for menorrhagia.
Sample Size A minimum of 220 female subjects relying on Essure micro- inserts seeking treatment for menorrhagia (i.e. NovaSure) at up to 30 US sites.
Data Collection Primary: Occurrence of confirmed pregnancy at 1 year and 3 years among subjects relying on Essure micro-inserts for permanent birth control when NovaSure is performed.

Secondary: Incidence of adverse events (AEs) and/or complications associated with the performance of NovaSure in the presence of Essure micro-inserts, reported during follow-up visits.
Follow-up Visits and Length of Follow-up 3 years
One week post NovaSure procedure, then one, two, and three year post-endometrial ablation Phone Call
Interim or Final Data Summary
Actual Number of Patients Enrolled 220 women with successful bilateral Essure insert location and tubal occlusion were enrolled, from which 215 met all the eligibility criteria. Among the 215 eligible women, 211 women had NovaSure attempted, and 209 women underwent the NovaSure endometrial ablation treatment. Out of all enrolled women (n=220), 11 women exited the study prior to a NovaSure treatment attempt (n=4), after NovaSure was attempted but before undergoing treatment (n=2) or were screening failures (n=5).
Actual Number of Sites Enrolled 25 sites were included in the study. Subjects were enrolled from 18 sites.
Patient Follow-up Rate Out of all enrolled patients (220 women), 174 women completed the study (79.1%). Out of the women who underwent a NovaSure treatment, 83.3% (174/209) completed the study. There were 35 women who discontinued from the study and 11 lost to follow-up. For each post-endometrial ablation visit, out of all eligible women (n=215), the follow-up rates were:
1-week: 97.2%
1-year: 92.6%
2-year: 86.5%
3-year: 81.4%
Final Safety Findings There were 211 women who had NovaSure attempted and make up the primary safety analysis cohort.

A total of 398 events were reported in 116/211 subjects (55.0%) from the primary safety cohort. There were 28 serious adverse events (SAEs) in 18 subjects and 370 non-serious adverse events in 113 subjects.

The AEs occurring in greater than or equal to 2% of subjects were pelvic pain (28 subjects, 13.3%); vaginal discharge (15 subjects, 7.1%); urinary tract infection (12 subjects, 5.7%); vaginal hemorrhage (10 subjects, 4.7%); heavy menstrual bleeding, dysmenorrhea, and nausea (9 subjects, 4.3% each); abdominal pain (7 subjects, 3.3%); procedural pain and uterine spasm (6 subjects, 2.8% each); and fatigue, uterine hemorrhage, and vulvovaginal pruritus (5 subjects, 2.4% each).

SAEs are a subset of all the reported AEs. The SAEs occurring in more than 2 subjects were pelvic pain (5 subjects, 2.4%) and heavy menstrual bleeding (2 subjects, 0.9%). One (n=1) subject (0.5%) died due to congestive cardiac failure; the death was assessed as not related to the Essure device, NovaSure device, or NovaSure procedure.

None of these events represent unanticipated adverse device effects and the events are consistent with available data for Essure and NovaSure.



Final Effect Findings No pregnancies were reported at any timepoint in the study. The 95% upper Bayesian credible interval was 1.23% and 1.33% at 1 year and 3 years, respectively, which meets the predetermined study success threshold of 2.1% and 2.8% at 1 year and 3 years, respectively.
Study Strengths & Weaknesses The study was designed to provide the pregnancy rate in women with successful bilateral Essure insert location and tubal occlusion who underwent NovaSure endometrial ablation treatment, with a confidence interval of 95%. One strength of the study is the high observed follow-up rate. A limitation of the study is the data collection through phone call follow-up visits, instead of a clinical exam.
Recommendations for Labeling Changes Not applicable. On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. As of December 31, 2019, all unused Essure units should have been returned to Bayer so that they are no longer available for implantation. The most recent labeling from 2018 includes warning and precautions about performing endometrial ablation of the uterus in patients with Essure inserts.

The most recent labeling indicates that investigations are ongoing to understand contraception rates in women with successful bilateral Essure insert location and tubal occlusion who underwent NovaSure endometrial ablation treatment. This post-approval study provides information on the subject population described above. In this post-approval study, the self-reported pregnancy rate among study participants relying on Essure micro-inserts for permanent birth control when NovaSure was performed was 0% at 1 year and 0% at 3 years. These post-approval study findings support the information already included in the labeling.


Essure/post-NovaSure PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/24/2012 12/14/2012 Overdue/Received
one year report 02/23/2013 03/08/2013 Overdue/Received
18 month report 08/24/2013 09/12/2013 Overdue/Received
two year report 03/21/2014 03/24/2014 Overdue/Received
three year report 02/23/2015 02/27/2015 Overdue/Received
42 month report due 08/23/2015 08/19/2015 On Time
four year report 02/23/2016 02/22/2016 On Time
five year report 02/22/2017 02/21/2017 On Time
six year report 02/23/2018 02/23/2018 On Time
seven year report 02/22/2019 02/22/2019 On Time
eight year report 02/22/2020 02/21/2020 On Time
nine year report 02/21/2021 02/12/2021 On Time
Final Report 07/22/2022 01/11/2022 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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