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.
Five case]control studies will be conducted in Denmark, Germany, and the United Kingdom for 5
rare disease outcomes: rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma.
Study Population Description
Women in Denmark, Germany, and the United Kingdom with the studied rare diseases (i.e., rare
CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma) as cases and women without any of the 5 studied rare diseases from the same countries as controls.
For each of the 5 case]control studies, 1,150 cases of women diagnosed with studied rare
disease identified from the specialized medical centers and cancer registries in Denmark, Germany and the UK will be enrolled. A total of 5,000 females identified from the same neighborhood as cases without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
Data will be collected by using questionnaires as well as electronic information provided by the
cancer registries/tumor centers. The same questionnaires will be used for cases and controls. The participating women will fill in the questionnaires on potential confounders (e.g., life] style related covariates) and exposure to breast implants. Similar questionnaires have been successfully used in previous case]control studies with self]administered questionnaires.
Followup Visits and Length of Followup
OSB Lead-Breast Implant Case Control Studies