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 is a prospective study cohort to continue the follow-up of premarket cohort to evaluate
the long term safety and effectiveness
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. Study includes women who received the device while undergoing reconstruction or revision between 1998 and November 17, 2006 are being followed through their 5th post-surgery year and evaluated at 1, 3, and 5 years to assess satisfaction and occurrence of local complications.
Sample Size
Between study start in 1998 and device approval in November 2006, there were 43,384 reconstruction
patients and 38,653 revision patients enrolled
Data Collection
Primary objectives are to evaluated and estimate the rates of local complications (for example, capsular
contracture, pain, implant rupture, seromas, and hematomas), and reoperations, and other longer term outcomes (connective tissue diseases, rheumatological signs and symptoms, neurological diseases, neurological signs and symptoms, specific health problems in the children born to women receiving Allergan Natrelle silicone gel filled breast implants, miscarriages and stillbirths, problems with lactation, cancer, and suicide through scheduled follow up visits. Other objectives include estimating the rate of rupture with mammography, potential interference of breast implant with timing of breast cancer diagnosis, and compliance with the recommended schedule for MRI screening for implant rupture.
Followup Visits and Length of Followup
There are 3 scheduled follow up visits at 1, 3 and 5 years. Length of follow up is 5 years.
