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
Focus Group Study
Study Population Description
Women interested in breast augmentation or reconstruction with Sientra Silicone Gel Breast Implants.
Four focus groups with 8-10 participants in each group in Los Angeles, CA and Dallas, TX.
Participants¿ answers to the questions regarding the effectiveness of patient labeling in communicating the risks
and benefits of breast implant surgery.
Followup Visits and Length of Followup
Final Study Results
Actual Number of Patients Enrolled
37 (18 in the augmentation group and 19 in the reconstruction group)
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
In general, feedback from the four groups was positive and most participants found the
to be helpful and beneficial in making an informed decision about breast implant surgery. Sientra is proposing revisions to the current Patient Educational Brochures based on comments from the participants. Information will be added to the brochures to guide patients to appropriate resources. In addition, the clinical study results will be updated and data presentation will be restructured with the 5-year follow-up data from the Post-approval PMA Cohort Study
for Sientra¿s Silicone Gel Breast Implants.
Study Strengths and Weaknesses
The focus group study is quick, usually inexpensive, and useful in exploring ideas and concepts
through group interaction. However, the analysis is qualitative, it is difficult to generalize results if small, unrepresentative samples of participants are used, and data analysis can be time consuming due to the open-ended nature of questions proposed for the focus group discussion.
Recommendations for Labeling Changes
No labeling change is recommended. The Focus Group Study was conducted to evaluate Patient Educational
Brochures. No safety/effectiveness data of the sponsor¿s approved device was collected in the study.