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 large PAS is a 10-year multi-center, prospective cohort study designed to compare targeted safety
outcomes of 39,390 subjects who elect to receive unilateral or bilateral silicone gel-filled breast implants to 15,240 subjects who elect to receive unilateral or bilateral saline-filled breast implants (control subjects).
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. 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.
The study will enroll 54,630 female subjects who elect to receive unilateral or bilateral breast
implant, including: - 39,390 subjects who receive silicone gel-filled breast implant, 15,240 subjects who receive saline-filled breast implants (control subjects).
1. The long-term safety profile of silicone breast implants, especially as it relates to connective
tissue diseases (CTD), neurological diseases, cancer (brain, lung, breast, and cervical/vulvar), and suicide and their associated signs and symptoms. 2. The impact of silicone breast implants on reproductive health (e.g., live vs. non-live births) and offspring health (i.e., congenital and neonatal anomalies and diseases of offspring conceived post-implant, including autoimmune diseases, cancer, and neurological diseases) 3. The impact of silicone breast implants on detection of breast cancer with mammography 4. Complications associated with silicone breast implants 5. The effect of silicone breast implants on overall feeling of satisfaction with life and with the decision to have implant surgery
Followup Visits and Length of Followup
There are 4 follow up clinic visits at 1 wk post surgery, 1 year, 4
years and 10 years. Additionally, there is a patient questionnaire that is assessed annually.