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
This study is a 10-year followup of the Core Clinical Study with the objecitve to
document the safety and effectiveness of Allergans (formerly Inamed) Silicone-Filled Breast Implants as indicated for breast augmentation, breast reconstruction, or breast implant revision in existing Core IDE Study patients.
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
940 participants, 46 sites.
Data Collection
Effectiveness endpoints are circumferential chest size change, bra cup size change (augmentation patients only), patient
satisfaction, quality of life ( measures of self-esteem, body image, and general health outcome). Safety endpoints are complication rates, reasons for re-operation and reasons for implant removal.
Followup Visits and Length of Followup
Patients were to be followed for 10 years. Patient follow-up is at 6 months, 1
year, 2 years, and annually through 10 years post-implant. Rupture is assessed for patients who have scheduled MRIs at years 1, 3, 5, 7, and 9 years to screen for silent rupture (i.e., MRI cohort) and those who are not assessed for rupture by scheduled MRIs (i.e., non-MRI cohort). All patients in the post-approval study will undergo MRI at 7 and 9 years post-implantation
Final Study Results
Actual Number of Patients Enrolled
715 patients including 455 primary augmentation, 147 revision-augmentation, 98 primary-reconstruction and 15 revision-reconstruction patients.
Actual Number of Sites Enrolled
23
Patient Followup Rate
The follow-up rates for each cohort varied, but the overall rate was above 65% at
Year 10. The follow-up rate was highest in the revision-reconstruction group and lowest in the revision-augmentation group. Specifically, the follow-up rate at Year 10
Final Safety Findings
The most commonly reported complications for all cohorts include capsular contracture, breast pain, swelling, symmetry,
wrinkling and implant malposition. The overall implant rupture rates by patient were 9.5% in the augmentation, 6.3% revision-augmentation, 27.2% in the reconstruction, and 6.7% in the revision-reconstruction cohort. The rate of any reoperation by 10 years post-implant was highest in the reconstruction cohort (71.5%), followed by revision cohorts (46.7% in the revision-reconstruction and 46.0% in the revision-augmentation cohorts), and lowest in the augmentation cohort (36.1%). 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 and ptosis. Specifically for the revision-reconstruction patients, nipple complications were reported as the most common reason for reoperation. The incidence of breast implant removal by 10 years post-implant was highest in the reconstruction cohort (53.8%), followed by in the revision-augmentation cohort (32.4%), in the augmentation cohort (18.6%) and in the revision-reconstruction cohort (13.3%). The most common reasons for replacement/removal vary depending on the indication group. The most common reasons for implant replacement and removals are as follow: Asymmetry, capsular contracture, device rupture, implant malposition and patient request for style/size change.
Final Effectiveness Findings
Majority of the patients and physicians were satisfied with the surgical outcome. In the augmentation
cohort, the patient and physician satisfaction was 93% and 94%, respectively, 84% and 83% in the augmentation revision cohort, 84% and 86% in the reconstruction cohort, 72% and 80% in the revision-reconstruction cohort
Study Strengths and Weaknesses
One of the study strength is that the study is 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
The labeling will be updated based on the safety and effectiveness results reported in the
