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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-Continued Access Study (Natrelle 410 CAS)

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Application Number P040046 / PAS002
Study Name OSB Lead-Continued Access Study (Natrelle 410 CAS)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multicenter, prospective, nonrandomized study to evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Full and Moderate Height/Projection Breast Implants in women who have undergone breast implant augmentation, reconstruction, or revision surgery.
Study Population Description Subjects signed informed consent documents and underwent implantation and some follow-up as part of the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study. Subjects who have not yet completed the 5-year timepoint and who are not lost to follow-up will be re-consented to participate in the 410CA-002 Clinical Study.
Sample Size The sample size of approximately 3,500 subjects across approximately 110 sites is based on the number of subjects previously enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study who were implanted with NATRELLE® 410 approved implant styles and who have not yet completed the 5-year timepoint nor have been lost to follow-up.
Data Collection At all post-implantation visits, the Investigator will evaluate the occurrence of local complications that occurred between office visits and inquire whether the subject has received a magnetic

resonance imaging (MRI) examination since the last scheduled visit to screen for implant rupture (including the dates of the MRIs), the subject will complete the Activities and Lifestyle questionnaire, the subject and Investigator will assess satisfaction with the implants,

and subjects who have undergone breast augmentation or reconstruction surgery will complete the Quality of Life questionnaire. Breast photographs will be taken at Year 1.

Additionally, a subset of subjects who were enrolled in the serial MRI cohort to evaluate the occurrence of asymptomatic rupture will undergo the final MRI at 5 years post-implantation.

Subjects enrolled in the MRI cohort who have both original study implants removed will not attend any subsequent MRI. Complications, reoperations, explantations, cancer, connective tissue disease (CTD), and reproduction and lactation outcomes will be captured at each study visit, and at any time during the study, as reported.

Follow-up Visits and Length of Follow-up Subjects will continue to be evaluated at their remaining follow-up visits 1, 2, and 5 years after primary implant surgery.
Final Study Results
Number of Patients A total of 7274 subjects were enrolled who reached the 5-year follow-up window: 3267 Augmentation,

1390 Revision-Augmentation, 1753 Reconstruction, and 864 Revision-Reconstruction.

The serial MRI cohort consisted of 158 subjects: 76 Revision-Augmentation, 37 Reconstruction, and 45

Revision-Reconstruction. There were no Augmentation subjects in the serial MRI cohort.

Number of Sites 52
Follow-up Rate At year 5, the follow-up rates by cohort were: 62.3% Augmentation, 54.7% Revision-Augmentation,

48.3% Reconstruction, and 54.7% Revision-Reconstruction.

Year 5 compliance for the MRI cohort was: 55.4% Revision-Augmentation, 55.9% Reconstruction, and

63.6% Revision-Reconstruction.

Safety Findings Following are the observed Year 5 Kaplan-Meier rates with 95% confidence intervals for key complications at the subject level by cohort:

Augmentation ¿ Reoperation 13.28% (12.06, 14.62); Implant removal with replacement 5.34% (4.55, 6.27); Implant removal without replacement 1.28% (0.93, 1.78); Implant rupture MRI cohort N/A; Implant rupture Non-MRI cohort 0.91% (0.59, 1.38); Capsular contracture, Baker Grade III/IV 3.88% (3.20, 4.70);

Revision-Augmentation ¿ Reoperation 29.29% (26.69, 32.09); Implant removal with replacement 16.78% (14.63, 19.21); Implant removal without replacement 4.42% (3.34, 5.84); Implant rupture MRI cohort 4.75% (1.56, 14.05); Implant rupture Non-MRI cohort 1.73% (0.99,

2.99); Capsular contracture, Baker Grade III/IV 8.70% (7.09, 10.65);

Reconstruction ¿ Reoperation 33.91% (31.38, 36.58); Implant removal with replacement

13.85% (12.04, 15.92); Implant removal without replacement 5.35% (4.24, 6.75); Implant rupture MRI cohort 3.45% (0.49, 22.05); Implant rupture Non-MRI cohort 1.19% (0.66, 2.14); Capsular contracture, Baker Grade III/IV 7.87% (6.42, 9.64);

Revision-Reconstruction ¿ Reoperation 33.79% (30.25, 37.62); Implant removal with replacement 17.16% (14.37, 20.42); Implant removal without replacement 6.49% (4.78, 8.78);

Implant rupture MRI cohort 0% (N/A); Implant rupture Non-MRI cohort 2.53% (1.45, 4.39); Capsular contracture, Baker Grade III/IV 8.89% (6.83, 11.54).
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 post-approval Continued Access Study was designed to evaluate 5-year device safety performance in subjects who underwent implantation and some follow-up as part of the 410 Continued Access (CA) Clinical Study or 410

Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study. The overall patient follow-up rate was 52.8% at Year 5. This follow-up rate limits the interpretation of the available safety results.

Label Changes No labeling change is recommended at this time. The labeling contains 3, 5, 7 and 10 year data from the extended pivotal cohort study (Core Post-Approval Study).

OSB Lead-Continued Access Study (Natrelle 410 CAS) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 02/20/2014 02/20/2014 On Time
Final Report 02/20/2015 02/20/2015 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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