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,
Detailed Study Protocol Parameters
Study Design Description
The study is designed to address postmarket questions for both Natrelle (P020056) and Natrelle 410
(P040046) silicone breast implants. The objectives of the study are to compare Round Responsive and Style 410 implants with saline implants or national norms in regard to long쳌]term safety (including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problem, effects on mammography, effects on satisfaction with breasts and psychosocial well쳌] being, and silicone subject compliance with magnetic resonance imaging (MRI) recommendations. This is a prospective observational study comparing targeted safety outcomes of subjects who elect to receive 1 or 2 Round Responsive implants or 1 or 2 Style 410 implants to national norms or those of a control group of women receiving saline breast implants.
Study Population Description
Women implanted with Allergan Natrelle silicone breast implants and Natrelle 410 highly cohesive silicone breast
implants and control women implanted with saline implants.
2,000 subjects with Allergan Round Responsive silicone gel쳌] filled breast implants and 245 subjects with
saline implants selected from the Breast Implant Follow쳌]up Study (BIFS) cohorts, and 530 newly enrolled Style 410 highly cohesive silicone breast implants.
Adverse events (including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and
symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problem, effects on mammography, effects on satisfaction with breasts and psychosocial well쳌]being, and silicone subject compliance with MRI recommendations.
Followup Visits and Length of Followup
Subject questionnaire will be collected annually. Office visits at Year 1, 4 and 10
for participants enrolled in the device group.
OSB Lead-Natrelle and 410 Combined Cohort