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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
The Adjunct study is a 5-year study, in which patients will be followed at 1,
3, and 5 years postoperatively to assess satisfaction and occurrence of local complications.
Study Population Description
The study population is as per device indication. This device is indicated for breast augmentation
for women at least 22 years old and for breast reconstruction for women of any age. Breast Augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the results of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
Sample Size
number of study sites: 2,958; 12,811 reconstruction patients were implanted with 23,090 implants
Data Collection
Safety endpoints include clinical complications such as infection, seroma, implant rupture and capsular contracture at
1 ,3, 5 years of follow-up and rheumatologic/immunologic symptoms and connective tissue disorders at 3, 5 years of follow-up
Followup Visits and Length of Followup
3 follow-up visits during 5 years of study (1, 3, 5 years post-implantation)
Final Study Results
Actual Number of Patients Enrolled
147,585
Actual Number of Sites Enrolled
4,684
Patient Followup Rate
44.0% at 1 year, 24.7% at 3 years, 13.8% at 5 years
Final Safety Findings
The 3 most commonly reported complications using the Kaplan-Meier cumulative incidence estimates at
5 years were:
asymmetry (18.6%), wrinkling (9.9%), and Capsular Contracture, Baker III/IV (8.3%) in the Reconstruction Cohort; asymmetry (23.7%), wrinkling (14.3%), and Capsular Contracture, Baker III/IV (11.7%) in the Revision-Reconstruction Cohort; wrinkling (12.3%), asymmetry (11.4%), and Capsular Contracture, Baker III/IV (9.2%) in the Revision- Augmentation Cohort.
The most common reasons by cohort for removal were: capsular contracture (36.4%), infection
(13.2%), and patient request for size and implant change (10.5%) in the Reconstruction Cohort;
capsular contracture (37.4%), leakage/rupture/ deflation (12.2%), and infection (11.5%) in the Revision-Reconstruction Cohort; capsular contracture (36.1%), leakage/rupture/ deflation (16.1%), and patient request for size and implant change (10.3%) in the Revision-Augmentation Cohort.
The Kaplan-Meier cumulative rupture rates at 5 years were: 1.8% in the Reconstruction Cohort; 3.6%
in the Revision-Reconstruction Cohort; 3.5% in the Revision-Augmentation Cohort.
Bilateral implantation, white, infra-mammary surgical approach and sub-glandular surgical approach showed a higher risk of rupture, and reconstruction, smooth surface implant, high profile implant, high education and sub-muscular surgical placement showed a lower risk of rupture.
Rheumatoid arthritis was the most common patient-reported rheumatic disease at 0.6%. Fibromyalgia and Raynaud's phenomenon were the most commonly reported rheumatic syndromes at 0.8% and 0.5% respectively.
Final Effectiveness Findings
N/A
Study Strengths and Weaknesses
A large number of patients were enrolled in the adjunct study. However, the study was
originally
designed to address the public health needs of reconstruction and revision patients before device approval and to gather safety data regarding short-term post-implant complications under a limited clinical protocol without follow-up goals. The overall patient follow-up rates at 1, 3 and 5 years in this final report were only 44.0%, 24.7% and 13.8% respectively. The poor patient compliance significantly limited meaningful interpretation of the available safety results.
