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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Postmarket Surveillance Study


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS160001 / PSS001
Date Current Plan Accepted 12/20/2018
Study Name Postmarket Surveillance Study
Root Document Number P020014 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Open-label, non-randomized, prospective observational cohort study of two cohorts of subjects who chose to undergo either hysteroscopic sterilization (Essure) or laparoscopic tubal sterilization.



Interim Data Posting



Information regarding interim study progress (such as number of study sites enrolled and number of patients enrolled) will be posted after the review of each study report. Study results will be posted at three timepoints, due to the statistical methods required for group comparisons. An update will occur once enrollment into the Essure arm is completed, once all subjects have reached three-year follow-up, and after study completion.



The FDA may also post on its website or otherwise make public postmarket surveillance interim summary data or the FDA’s analyses thereof when appropriate to protect the public health, for example when interim results raise safety concerns or may otherwise impact treatment.
Study Population Description The study population will include subjects who are at least 21 years of age who have not been pregnant within the past 6 weeks.



The study population will include women who chose to undergo hysteroscopic sterilization (Essure) or laparoscopic tubal sterilization.

Sample Size On July 20, 2018, Bayer announced that Essure sales will stop in the United States after December 2018. Health Care providers can implant Essure up to one year from the date the device was purchased. The planned sample size of 1,400 women per arm is no longer feasible. The FDA is requiring study enrollment into the Essure arm to continue as long as Essure is available in the U.S. Enrollment into the laparoscopic tubal sterilization arm will stop after it reaches approximately 2:1 ratio with the Essure arm.

Data Collection Main Safety Endpoints:

• Chronic lower abdominal and/or pelvic pain

• Abnormal uterine bleeding (new onset or worsening)

• Hypersensitivity and allergic reactions, and autoimmune disorders (new onset) or autoimmune- like reactions

• Invasive gynecologic surgery including Essure insert removal



Secondary Safety Endpoints:

• Other adverse events

• In the event of a device removal or event of interest, additional data collection may include bloodwork, pathology, histology, and metallurgic testing, as appropriate



Effectiveness:

• Pregnancy

Follow-up Visits and Length of Follow-up Follow-up measures will include adverse event assessment, medical history including gynecological procedures, patient reported outcome (PRO) measures for chronic pelvic pain and abnormal uterine bleeding, levels of inflammatory markers and human leukocyte antigen (HLA) type, additional bloodwork for women with certain adverse events, and analysis of removed Essure devices.



60 months

Interim or Final Data Summary
Actual Number of Patients Enrolled As of April 1, 2019, 891 patients have been enrolled (307 in the Essure arm and 584 in the laparoscopic tubal ligation arm).
Actual Number of Sites Enrolled As of April 1, 2019, 67 sites have been enrolled. 62 sites are open for enrollment.


Postmarket Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
study plan report 03/30/2016 03/29/2016 On Time
6 month report 03/03/2017 03/03/2017 On Time
1 year report 09/02/2017 09/01/2017 On Time
18 month report 03/03/2018 03/01/2018 On Time
2 year report 09/02/2018 08/31/2018 On Time
30 month report 03/04/2019 03/04/2019 On Time
3 year report 09/03/2019 09/03/2019 On Time
4 year report 09/01/2020    
5 year report 09/01/2021    
6 year report 09/01/2022    
7 year report 09/01/2023    
8 year report 09/01/2024    
Final report 04/01/2025    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

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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