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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
The Continued Access Study (CAS) was initiated under an FDA-approved investigational device exemption to provide
supplemental data to the Core Clinical Study. The PACAS is to continue clinical follow-up of the primary augmentation and revision augmentation subjects previously enrolled in Sientra¿s CAS until each subject reaches her 5th year post-implantation.
Study Population Description
Women who received Sientra¿s silicone breast implants and were enrolled in the premarket augmentation cohorts
of the Continued Access Study. The data obtained at baseline on each subject will be used as the control data for physical status, cancer history and status, rheumatologic history and status, medical history and status, and CTD history and status.
A total of 2,497 subjects have been enrolled in Sientra¿s PACAS at 33 sites throughout
the United States.
The safety endpoints include local complications, implant rupture, connective tissue diseases (CTDs), CTD signs and
symptoms, lactation complications, cancer and suicide. Effectiveness will be assessed based on quality of life (QOL) assessments and subject satisfaction.
Followup Visits and Length of Followup
5 years Annually
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
48.5% for both primary and revision augmentation cohorts at Year 5
Final Safety Findings
The Kaplan쳌]Meier risk rate of any complication at Year 5 was 34.8% in the primary
augmentation cohort and 46.0% in the revision쳌]augmentation cohort.
The most commonly reported complications in the primary augmentation cohort were Baker Grade III/IV capsular contracture and nipple sensation changes (10.0% and 4.6%, respectively). In the revision쳌] augmentation cohort, the most commonly reported complications were Baker Grade III/ IV capsular contracture, implant malposition and nipple sensation changes (13.3%, 5.7% and 5.7% respectively).
The Kaplan쳌]Meier risk rate of reoperation was 20.2% in the primary augmentation cohort and 31.1% in the revision쳌]augmentation cohort.
The Kaplan쳌]Meier risk rate of implant explantation was 10.4% in the primary augmentation cohort and 16.3% in the revision쳌]augmentation cohort.
In the primary augmentation cohort there were four devices confirmed ruptured via explant and one device unconfirmed for a total of five reported ruptures through 5 years. In the revision쳌]augmentation cohort there was one device confirmed ruptured via explant and three devices with unconfirmed ruptures for a total of four reported ruptures through 5 years.
There were no unanticipated adverse device events among the study subjects.
Final Effectiveness Findings
In the primary augmentation cohort, 88.8% of patients increased their bra cup size by at
least one cup, 79.2% increased by one to two cup sizes, while 9.5% increased by more than two cup sizes. Only 6.6% of the primary augmentation subjects achieved less than a one쳌]cup size increase.
Study Strengths and Weaknesses
The Continued Access Study (CAS) was designed to provide supplemental safety and effectiveness data for the
premarket clinical study and to address the public health needs before device approval. It was conducted under the same protocol as the premarket clinical study. The subjects from the primary and revision reconstruction cohorts of the CAS were added to the premarket clinical study to support device approval and are now part of the Post쳌]approval PMA Cohort Study that will be followed for 10 years post쳌]implantation. The Post쳌]approval Continued Access Study (PACAS) only includes subjects from primary and revision쳌]augmentation cohorts of the CAS. The overall patient follow쳌]up rate of the PACAS was only 48.5% at Year 5. The low patient compliance significantly limited meaningful interpretation of the available safety results.
Recommendations for Labeling Changes
No labeling change recommended at this time. The labeling will be updated based on the
5쳌]year clinical data from the Post쳌]approval PMA Cohort Study for the same device.
Post-Approval Continued Access Study (PACAS)