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
Prospective cohort study (two arms, i.e., patients receive Natrelle
410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast
implants and patients who receive Natrelle Saline Implants), multicenter.
Study Population Description
Women who are implanted with the Natrelle Highly Cohesive Silicone-Filled Breast Implants for augmentation or
reconstruction purposes, and women who are implanted with Natrelle Saline Implants.
2,287 women with the Natrelle Highly Cohesive Silicone-Filled
Breast Implants and 300 women with Natrelle Saline
The effectiveness endpoints are subject satisfaction with breasts and psychosocial well-being measured using the BREAST-Q.
safety endpoints include subject and Investigator reports of CTD (Chronic fatigue syndrome, Fibromyalgia, Rheumatic polymyalgia, Rheumatoid arthritis, Undifferentiated CTD), cancer (lung and breast, including breast implant interference with mammography and delay of breast cancer detection), suicide/attempted suicide, rheumatologic and neurologic signs and symptoms, local complications, reoperation, implant removal with and without replacement, reproductive complications, congenital deformities and lactation complications. Subjects and Investigators may also report other cancers, CTDs, and neurological
Followup Visits and Length of Followup
Patients will be followed for 10 years.
Patients will complete questionnaires annually. There will be