• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

New Enrollment Post-Approval Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number /
Requirement Number
P230005 / PAS002
Date Original Protocol Accepted 11/22/2024
Date Current Protocol Accepted  
Study Name New Enrollment Post-Approval Study
Device Name Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breast Implants
Clinical Trial Number(s) NCT03579901 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection at baseline and annually Years 1-10
The Post Approval Study is a new enrollment study that will examine the general post market use and endpoints not addressed during premarket studies in women who are undergoing primary augmentation and revision augmentation breast surgery to correct or improve the results of a primary breast augmentation, and in a group of control subjects undergoing an aesthetic procedure other than breast implant surgery
Study Population Subject population of 2,400 subjects in three cohorts:
- 1,500 primary augmentation subjects implanted with approved Motiva devices
- 500 revision augmentation subjects implanted with approved Motiva devices
- 400 control subjects consisting of women undergoing an aesthetic procedure other than breast implant surgery
Sample Size Number of subjects: 2400
Assumptions for sample size estimation: Sufficient sample size assuming worst-case (40%) loss-to-follow-up to have sufficient power (at least 80%) to detect a 2.0 odds ratio for CTD and systemic signs and symptoms differences between the Motiva group and Control group when the incidence in the control group is at least 10%.
Number of sites: 50
Sites location: in the US
Key Study Endpoints Safety Endpoints
Primary: Patient-reported incidence of CTD and systemic signs and symptoms using a questionnaire including the PROMIS-29 Survey, a validated tool that assesses eight health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference and cognitive functions and compare them among study groups (i.e., implanted vs control)
Secondary:
- Patient-reported incidence of reproductive complications, cancer (including breast cancer), local complications (including suspected rupture), reoperation, implant removal comparing (a) Round to Round Ergonomix devices, (b) Non-White participants to White participants, (c) RFID devices to non-RFID devices, and d) Implanted vs Controls, where data collection allows
- Assess the impact of RFID on imaging (MRI or ultrasound)
Effectiveness Endpoints
Primary: none
Secondary: Patient Satisfaction
Follow-up Visits and Length of Follow-up Annual follow-up visit (questionnaire) administered annually for 10 years.


New Enrollment Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/27/2025    
1 year report 09/26/2025    
18 month report 03/27/2026    
2 year report 09/26/2026    
3 year report 09/26/2027    


Contact Us

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

Additional Resources

-
-