In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
OSB Lead-Continued Access Study (Natrelle 410 CAS)
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Transit. Adolescent B (as adults) : 18-21 yrs,
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.
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.
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.
Followup Visits and Length of Followup
Subjects will continue to be evaluated at their remaining follow-up visits 1, 2, and 5
years after primary implant surgery.
Final Study Results
Actual Number of Patients Enrolled
A total of 7274 subjects were enrolled who reached the 5-year follow-up window: 3267 Augmentation,
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.
Actual Number of Sites Enrolled
Patient Followup Rate
At year 5, the follow-up rates by cohort were: 62.3% Augmentation, 54.7% Revision-Augmentation,
48.3% Reconstruction, and
Year 5 compliance for the MRI cohort was: 55.4% Revision-Augmentation, 55.9% Reconstruction, and
Final Safety Findings
Following are the observed Year 5 Kaplan-Meier rates with 95% confidence intervals for key complications
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.
Recommendations for Labeling 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)