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,
Final Study Results
Actual Number of Patients Enrolled
941 patients including 492 primary augmentation, 156 revision- augmentation, 225 primary reconstruction and 68 revision-reconstruction.
Actual Number of Sites Enrolled
Patient Followup Rate
The follow-up rate at 10 year was highest in the reconstruction group and lowest in
the revision-augmentation group. Specifically, the follow-up rate at Year 10 by cohorts were as follows: 66% in the augmentation cohort, 55% in revision-augmentation, 81% in the reconstruction and 77% in the revision-reconstruction.
Final Safety Findings
The most commonly reported complications vary by the indication group. The most commonly reported complications
at 10 years by indication group are as follow: Augmentation cohort: Capsular contracture (9.2%), implant malposition (4.7%), breast pain (4.5%) and swelling (4.0%); Revision-augmentation cohort: Capsular contracture (11.9%), implant malposition (9.1%), asymmetry (6.9%) and breast pain (5.2%); Reconstruction cohort: Capsular contracture (14.5%), asymmetry (12.4%), breast pain (8.2%) and wrinkling/rippling (6.2%); Revision-reconstruction: Capsular contracture (26.8%), asymmetry (17.4%), wrinkling/rippling (12.8%) and infection (8.5%);
The overall implant rupture rates at 10 years by patient were 11.9% in the augmentation, 13.0% in the revision-augmentation, 8.5% in the reconstruction, and 9.7% in the revision-reconstruction cohorts.
The rate of any reoperation by 10 years post-implant was highest in the reconstruction cohort (54.6%), followed by revision cohorts (48.5% in the revision-reconstruction and 47.3% in the revision- augmentation cohorts), and lowest in the augmentation cohort (29.7%). The most frequently reported reason for reoperation varied with the indication. The most common primary reasons for reoperation were asymmetry, capsular contracture, device rupture, implant malposition, need for biopsy, patient request for style/size change, hematoma/seroma, infection, scarring and ptosis.
The incidence of breast implant removal by 10 years post-implant was highest in the revision- reconstruction cohort (42.4%), followed by reconstruction cohort (38.3%), revision-augmentation cohort (31.0%) and the augmentation cohort (19.6%). The most common reasons for replacement/removal
vary depending on the indication group. The most common reasons for implant replacement and removals are as follows: asymmetry, capsular contracture, device rupture, implant malposition and patient request for style/size change.
Final Effectiveness Findings
The majority of the patients and physicians were satisfied with the surgical outcome at 10
years. In the augmentation cohort, the patient and physician
satisfaction was 95% and 96%, respectively, 86% and 85% in the augmentation-revision cohort, 92% and
91% in the reconstruction cohort, 78% and 80% in the revision-reconstruction cohort.
Study Strengths and Weaknesses
One of the study strengths is that the study was a prospective, multicenter study that
provides long term data up to 10 years on the safety and effectiveness of the device. The weaknesses of the study were the lack of a comparison group and lack of statistical power to detect rare events due to the small sample size.
Recommendations for Labeling Changes
Yes. The labeling will be updated based on the safety and effectiveness results reported in
the final PAS report since these results will provide patients and physicians with long term data (10-years) on the performance of the device.