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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-Post-Approval PMA Cohort Study (PACS)


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General
Application Number P060028 / PAS001
Current Plan Approved 06/14/2013
Study Name OSB Lead-Post-Approval PMA Cohort Study (PACS)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The MemoryShape Core Study is a post-approval cohort study to assess safety and effectiveness in augmentation, reconstruction, and revision (augmentation and reconstruction) patients. As part of the PMA conditions of approval, MemoryShape Core Study subjects will be expected to complete annual follow-up visits for safety and effectiveness through 10 years as well as MRI scans for all subjects at year 10.
Study Population Description Women with Mentor¿s MemoryShape Breast Implants as indicated for primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction of the female breast.
Sample Size A total of 955 subjects have been enrolled in MemoryShape Core Study. The protocol does not specify the number of clinical sites.
Data Collection During the 10-year follow-up period, long-term safety of the Implants will continue to be measured by collecting the incidence, severity, method of resolution and duration for all complications (including device failures and adverse device effects) on a per-implant and per- patient basis. MRI scans to detect silent rupture of the implant for a subset of patients are at 1, 2,

4, 6, 8, and 10 years. Additionally, all patients are scheduled to receive MRI scans at year 6, 8 and 10. Safety assessments include complication rates, reasons for reoperation, and reasons for implant removal. Effectiveness assessments include bra cup size change (augmentation patients only), circumferential chest size change, measures of patients¿ satisfaction, and assessments of body image, self-esteem, and health related quality of life.

Follow-up Visits and Length of Follow-up Subjects will be seen by the investigator in the investigator's office once a year until all subjects have reached 10-years post-implantation. In addition, all subjects in the study are scheduled to receive MRI scan at 10 years post-implantation.
Final Study Results
Number of Patients In total, 955 female subjects, including 572 primary augmentation, 124 revision-augmentation,

190 primary reconstruction, and 69 revision-reconstruction subjects, were enrolled.



Enrollment in the MRI Substudy included 252 primary augmentation, 56 revision-augmentation, 73 primary reconstruction, and 38 revision-reconstruction subjects.

Number of Sites 43
Follow-up Rate The follow-up rate at 10 years ranged from 60% to 74% across cohorts, with an overall follow-up rate of

63%. The cohort specific follow-up rates were as follows: 60% primary augmentation, 63% revision- augmentation, 67% primary reconstruction, and 74% revision-reconstruction.



The follow-up rates at 10 years for the MRI subset of subjects ranged from 42% to 57% across cohorts, with an overall follow-up rate of 45%. The cohort specific MRI Substudy follow-up rates were as fo
Safety Findings The Kaplan-Meier estimated cumulative incidence rates at the subject level for the complications of any reoperation, explantation with or without replacement, explantation with replacement with study device, Baker III/IV capsular contracture, and infection are presented by cohort.



For the primary augmentation cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 3.6%; infection, 0.7%; explantation with or without replacement, 9.2%; explantation with replacement with study device, 4.0%; and any reoperation, 22.3%.



For the revision-augmentation cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 15.5%; infection, 1.9%; explantation with or without replacement, 25.9%; explantation with replacement with study device, 10.8%; and any reoperation, 35.0%.



For the primary reconstruction cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 14.3%; infection, 1.6%; explantation with or without replacement, 34.1%; explantation with replacement with study device, 16.7%; and any reoperation, 52.7%.



For the revision-reconstruction cohort, the KM estimated 10-year cumulative incidence rates were as follows: Baker Grade III/IV capsular contracture, 16.4%; infection, 2.9%; explantation with or without replacement, 49.0%; explantation with replacement with study device, 27.9%; and any reoperation, 59.7%.



The Kaplan-Meier estimated cumulative incidence rates for rupture through 10 years for the MRI substudy subjects by cohort were: 6.6% primary augmentation, 9.6% revision- augmentation, 18.9% primary reconstruction, and 0% revision-reconstruction.

Effect Findings For the primary augmentation cohort, the overall mean change in circumferential chest size through 10 years was 2.1 inches and statistically significant (p<0.0001), and the overall mean bra cup size increase from baseline across all follow-up visits was 2.2 cup sizes and statistically significant (p<0.0001). The primary effectiveness analysis was for the primary augmentation cohort only.



The percentage of subjects who answered the Global Subject Satisfaction question indicating they would make the same decision to have breast implant surgery was 96.9% at the Year 10 follow-up visit. The results were similar for the four subject cohorts: 96.6%, 95.5%, 100.0%, and 94.1% for the primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction cohorts, respectively.

Strengths & Weaknesses One study strength is the 10-year prospective multi-center design to assess the long-term safety and

effectiveness of the device. The weaknesses of the study were the lack of a comparison group, and lack of statistical power to detect rare events due to the sample size.

Label Changes Yes, the labeling will be updated based on the post-approval study results to provide patients and physicians with 10-year descriptive data on device performance.


OSB Lead-Post-Approval PMA Cohort Study (PACS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Device Retrieval report 06/14/2014 06/09/2014 On Time
one year report 06/14/2014 06/12/2014 On Time
final report 06/19/2015 06/08/2015 On Time


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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