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.
The Core study is a 10-year prospective, open-label, multi-center cohort study to evaluate the safety
and effectiveness of MemoryGel breast implants
Study Population Description
The study populaiton 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.
1000 patients at up to 40 sites
Safety endpoints include point prevalence on a per patient and per device basis of rates
of occurrence of all adverse events and time to occurrence of the complication; Effectiveness endpoints include patient satisfaction measured by validated quality of life questionnaires and change in breast size measured by both bra and cup size and the chest/bust circumference.
Followup Visits and Length of Followup
11 follow-up visits (6 months and annually 1-10 years after surgery) during 10 years of study
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
62% at 10 years
Final Safety Findings
For the Primary Augmentation cohort, the 10-year Kaplan-Meier estimated cumulative incidence rates for the key
complications at the patient level were: capsular contracture III/IV, 12.1%; infection, 1.6%;
explantation with or without replacement, 11.6%; explantation with replacement with study device, 7.4%;
and any reoperation, 25.5%. The most frequently reported primary reasons for reoperation were capsular contracture II/III/IV (25.4% of reoperations) and breast mass (10.6% of reoperations).
For the Revision-Augmentation cohort, the rates were: capsular contracture III/IV, 24.4%; infection,
1.4%; explantation with or without replacement, 24.1%; explantation with replacement with study device,
13.6%; and any reoperation, 43.6%. The most frequently reported primary reason for reoperation was capsular contracture II/III/IV (30.4% of reoperations).
For the Primary Reconstruction cohort, the rates were: capsular contracture III/IV, 20.5%; infection,
6.2%; explantation with or without replacement, 33.4%; explantation with replacement with study device,
19.8%; and any reoperation, 49.0%. The most frequently reported primary reasons for reoperation were asymmetry (16.6% of reoperations), capsular contracture II/III/IV (14.0% of reoperations), rupture (12.7% of reoperations), and breast mass (10.8% of reoperations).
For the Revision-Reconstruction cohort, the rates were: capsular contracture III/IV, 36.9%; infection, 0%;
explantation with or without replacement, 37.8%; explantation with replacement with study device,
24.8%; and any reoperation, 50.7%. The most frequently reported primary reasons for reoperation were capsular contracture II/III/IV (23.4% of reoperations) and breast mass (12.8% of reoperations).
Overall, the most frequently reported reasons for explantation through 10 years were size change, capsular contracture II/III/IV, and rupture. Based on the MRI cohort, the overall Kaplan-Meier estimated cumulative rupture rates at 10 years were 27.9% and 18.5% for patients and implants, respectively
Final Effectiveness Findings
The overall mean changes in circumferential chest size were positive and statistically significant. The overall
mean bra cup size increase from baseline across all follow-up visits was 1.8 cup sizes and was statistically significant. At the 10-year follow-up visit, overall 97.6% of patients indicated they would make the same decision to have breast implant surgery.
Study Strengths and Weaknesses
One of the study strengths 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 10-year safety and effectiveness results reported in