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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-MemoryGel and Shape Combined Cohort


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General
Application Number P060028 / PAS003
Current Plan Approved 02/12/2016
Study Name OSB Lead-MemoryGel and Shape Combined Cohort
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 Design Description This is a new enrollment prospective (10-year) post-approval cohort study to collect additional post-approval clinical data on the long-term clinical performance of MemoryShape and MemoryGel Breast Implants.
Study Population Description Women who receive Mentor?s MemoryGel and MemoryShape breast implants for the purpose of primary or revisional breast augmentation and primary or revisional breast construction. Additionally, women who undergo aesthetic surgery (for example liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty) will be enrolled as concurrent controls.

Sample Size The study will enroll 2,518 women who receive Memory Gel and MemoryShape Breast Implants for augmentation, reconstruction, augmentation revision, or reconstruction revision. The study will also enroll 300 women undergoing aesthetic surgery who will serve as concurrent control group.

The study was designed to have 80% power to be able to detect as statistically significant a relative risk of 2.0 for adverse events that occur,

without implants with a frequency of 5.0 per 10,000 person-years, based on a one-sided test conducted at level of significance of 0.05. Based on these specifications, it was determined that approximately 20,328 person-year, a total of at least 2,518 breast implants patients would be required. Patient are to be followed for 10 years. For purposes of sample size calculationns, assuming a follow-up rate of 65% at 10 years and a linear loss to follow-up, there would be an average of 8, 075 person-years per patient. Thus, in order to obtain the 20,328 person-years, a total of 2,518

breast implants patients would be required.



Data Collection Safety Endpoints to be evaluated are as follows:

Local complications, connective tissue diseases, rheumatologic and neurologic signs and symptoms, cancer, suicide, and lactation complications

and magnetic resonance imaging (MRI) compliance and results.



Effectiveness BREAST-Q will be assessed in a subset of breast implant patients, approximately 500 patients, by responses to questions addressing their perceived quality-of-life and satisfaction with their breast implants.



Follow-up Visits and Length of Follow-up Patients will be followed for 10 years. MemoryGel and Memory Shape Breast Implant patients will be evaluated by the investigator at baseline and years 1, 5, and 10, and will complete questionnaires at baseline and annually for 10 years. A concurrent control group of women undergoing other aesthetic surgery (patients are referred to as Control participants) will complete questionnaires at baseline and annually for 10 years.



OSB Lead-MemoryGel and Shape Combined Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/13/2013 12/09/2013 On Time
one year report 06/14/2014 06/10/2014 On Time
18 month report 12/13/2014 12/08/2014 On Time
two year report 06/14/2015 06/03/2015 On Time
3 year report 08/12/2016 08/10/2016 On Time
42 month report 02/12/2017    
4 year report 08/13/2017    
54 month report 02/12/2018    
5 year report 08/13/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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