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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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NovaSure PAS

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Study Status Completed
Application Number /
Requirement Number
P010013 S041/ PAS001
Date Original Protocol Accepted 02/01/2013
Date Current Protocol Accepted 01/04/2022
Study Name 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 Objectives Prospective, single-arm, multi-center study
Study Population Premenopausal women greater than or equal to 18 years old with menorrhagia due to benign causes for whom childbearing is complete and have received an Essure Permanent Birth Control System
Sample Size Up to 21 sites, 318 patients
Key Study Endpoints 1. Primary Endpoint: Removal of an Essure micro-insert with the NovaSure device
2. Secondary Endpoints:
2.1. AEs during and/or immediately following the NovaSure procedure;
2.2. AEs up to 1 month after the NovaSure procedure
Follow-up Visits and Length of Follow-up 1 Month
1 Follow-up assessment
Interim or Final Data Summary
Actual Number of Patients Enrolled 16
Actual Number of Sites Enrolled 16
Patient Follow-up Rate Out of all enrolled patients (148), 127 patients completed the study (85.8%). Out of the women who underwent a NovaSure treatment, 95.4% (127/133) completed the study. There were 15 patients who were screened after enrollment and 6 lost to follow-up.
Final Safety Findings Note: The original study enrolled 127 patients that underwent NovaSure post Essure placement and completed the study. Data from the original study was supplemented with data from Bayer Pharma AG’s study (P020014/S017/PAS001) with a comparable patient population. Supplemental data provided from the Bayer study included 211 treated patients, bringing the total number of patients evaluated with these two data sets (Hologic and Bayer) to 338. Please see the P020014/S017/PAS001 database for more details. Outcomes below are broken down by study.

Removal of Essure Inserts with NovaSure Device:
There were no inadvertent removals of an Essure micro-insert due to snagging on the NovaSure array in both Hologic’s and Bayer’s studies.

AEs During and/or Immediately following NovaSure Procedure and up to 1 Month following the Procedure:

Hologic Study
A total of 102 events were reported in 48/127 subjects (37.8 %). There were 0 serious adverse events (SAEs). Among 102 adverse events (AEs), 72 events were during and/or immediately following the NovaSure procedure and 30 events were up to 1 month after the NovaSure procedure.
The AEs occurring in greater than or equal to 2% of subjects were uterine spasm (28 subjects, 22.0%); vaginal hemorrhage (24 subjects, 18.9%); vaginal discharge (19 subjects, 15.0%); abdominal pain (6 subjects, 4.7%); nausea (3 subjects, 2.4%); and vomiting (3 subjects, 2.4%).

Bayer Study
Data from the Bayer study did not distinguish between events immediately after the procedure or up to 1 month following, as initial follow up was recorded at 1 month. A total of 94 events were reported in 53/211 subjects (25.1 %) within 1 month from the NovaSure procedure. There were 4 SAEs in 3/211 subjects within 1 month from the NovaSure procedure.
The AEs occurring in greater than or equal to 2% of subjects were vaginal discharge (12 subjects, 5.7%); pelvic pain (9 subjects, 4.3%); vaginal hemorrhage (8 subjects, 3.8%); uterine spasm (6 subjects, 2.8%); abdominal pain (6 subjects, 2.8%); nausea (6 subjects, 2.8%); and procedural pain (5 subjects, 2.4%).

Final Effect Findings There were no key endpoints related to the effectiveness of the NovaSure device.
Study Strengths & Weaknesses The study enrollment did not meet original sample size (318). While supplemental data were provided from the Bayer study which had a similar patient population, there were differences in protocol between the two studies that may impact poolability (e.g., initial follow up timepoint, primary endpoint). Therefore, caution should be taken with interpretation of the combined results.

Recommendations for Labeling Changes None, the NovaSure labeling approved in S041 that required this PAS already includes information regarding potential thermal injury following ablation in patients with Essure inserts.

NovaSure PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/02/2013 08/02/2013 On Time
one year report 02/01/2014 02/03/2014 Overdue/Received
18 month report 08/02/2014 07/31/2014 On Time
two year report 02/01/2015 01/30/2015 On Time
30 month report 08/01/2015 07/31/2015 On Time
three year report 02/01/2016 02/01/2016 On Time
42 month report 08/01/2016 07/29/2016 On Time
four year report 01/31/2017 01/31/2017 On Time
54 month report 08/01/2017 08/01/2017 On Time
five year report 01/31/2018 01/29/2018 On Time
66 month report 08/01/2018 08/06/2018 Overdue/Received
6 year report 03/01/2019 03/29/2019 Overdue/Received
final report 02/01/2020 01/31/2020 On Time
final report 08/12/2022 08/12/2022 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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