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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 Cont Access Study (PACAS)


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General
Application Number P060028 / PAS002
Current Plan Approved 06/14/2013
Study Name OSB Lead-Post-approval Cont Access Study (PACAS)
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 Continued Access Study (CAS) was initiated to allow for continued physician experience with the device and to collect additional safety data. The PACAS is a post-approval continued access study designed to evaluate the safety of Mentor¿s MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants in subjects previously enrolled in Mentor¿s CAS. Upon device approval, CPG CA study subject enrollment will be closed and the study will be converted to a post approval study for this style, i.e., CPG Style 321. The PACAS is to continue clinical follow-up of these patients with CPG Style 321 until each patient reaches her 5th year post-implantation. Subjects enrolled in the CA study with other CPG style breast implants will be followed under a new IDE protocol and study.

Study Population Description Women with Mentor¿s MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants as indicated for primary augmentation and revision augmentation of the female breast who were enrolled in the CAS but have not yet completed their 5-year follow-up.
Sample Size A total of approximately 350 subjects who were enrolled in Mentor¿s Continued Access Study and implanted with MemoryShape Medium Height, Moderate Profile (CPG Style 321) for augmentation and reconstruction of the female breast and have not yet completed the 5-year study visit
Data Collection During the 5-year follow-up period, 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. Rheumatic Disease questionnaire will be employed at years 1, 2, 4 and 5. All PACAS subjects will be advised to see their surgeon if they believe they have a ruptured implant, and these subjects will undergo a Magnetic Resonance Imaging (MRI) scan.
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 5-years post-implantation. Follow-up study visits will take place at 10 weeks and then annually through 5 years after surgery.
Final Study Results
Number of Patients 2,003
Number of Sites 62
Follow-up Rate 62% at Year 5
Safety Findings For the primary augmentation cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 0.7%; infection, 0.6%; explantation with or without replacement, 4.2%; explantation with replacement with study device,

1.1%; and any reoperation, 9.4%.



For the revision쳌augmentation cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 0.6%; infection, 1.4%; explantation with or without replacement, 8.7%; explantation with replacement with study device,

2.5%; and any reoperation, 17.9%.



For the primary reconstruction cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 5.3%; infection, 0.6%; explantation with or without replacement, 13.0%; explantation with replacement with study device,

7.6%; and any reoperation, 24.6%.



For the revision쳌reconstruction cohort, the KM estimated 5쳌year cumulative incidence rates for the key complications at the subject level were: Baker Grade III/IV capsular contracture, 9.8%; infection, 3.2%; explantation with or without replacement, 16.6%; explantation with replacement with study device,

6.0%; and any reoperation, 25.1%.



A total of 10 ruptures were reported, of which 9 were silent rupture.

Effect Findings N/A
Strengths & Weaknesses The Continued Access Study (CAS) was initiated to allow for continued physician experience with the device before device approval and to collect additional safety data. The Post쳌]approval Continued Access Study (PACAS) was designed to evaluate the safety of MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants in subjects previously enrolled in the CAS. The overall patient follow쳌]up rate of the PACAS was 62% at Year 5. This follow쳌]up rate limited the interpretation of the available safety results.
Label Changes No labeling change recommended at this time. The labeling has already contained 3쳌and 6쳌year data from the premarket cohort study and will be updated based on the 10쳌year clinical data from the Post쳌approval PMA Cohort Study for the same device.



OSB Lead-Post-approval Cont Access Study (PACAS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report-Final Report 10/30/2014 10/24/2014 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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