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
Five case-control studies will be conducted in Brazil for 5 rare disease outcomes: rare CTDs,
neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. The studied diseases will be identified from patient populations treated at the medical centers and hospitals in which the participating Brazilian Principal investigators are affiliated. Study sites will be located in metropolitan urban areas of Southern Brazil, which include Rio de Janeiro, Sao Paulo, and Porto Alegre, among other cities. Study participants will be asked to complete a questionnaire. Information on exposure to Sientra¿s Silicone Gel Breast Implants will be obtained retrospectively. Additionally, participant medical records will be reviewed for relevant study information. One large control group from the same medical centers and hospitals as cases will be used as a comparator for the studies.
Study Population Description
The case-control studies will be conducted in metropolitan urban areas of Southern Brazil.
Gel Breast Implants have been widely used in Brazil for more than a decade, providing the opportunity to evaluate rare disease outcomes, and its potential association in women with Sientra¿s Implants.
Inclusion criteria for cases:
¿ Between 24 and 70 years of age at the time of enrollment
¿ The rare disease outcomes were identified and/or treated at a clinic collaborating in Sientra¿s post-approval study
Exclusion criteria for cases:
¿ Deceased since diagnosis
¿ Diagnosis prior to March 1997
Inclusion criteria for the controls:
¿ Between 24 and 70 years of age at the time of enrollment
¿ Free from any of the diseases that will be evaluated as part of Sientra¿s post-approval study (i.e., rheumatic disease, neurological diseases, cancers of the cervix or brain, or lymphomas)
¿ Within selected age range of case definitions (frequency matched in 5-year age ranges)
¿ Within the general geographic region from which cases are recruited
¿ Currently a patient at one of the hospitals or clinics that provided cases for the studies.
Exclusion criteria for the controls:
¿ Previous diagnosis of one or more of the conditions of interest (i.e., rheumatic disease, neurological diseases, cancers of the cervix or brain, or lymphomas)
For each of the 5 case-control studies, 1,280 cases of women diagnosed with studied rare
disease at medical centers and hospitals in metropolitan urban areas of Southern Brazil will be enrolled. A total of 3,800 female hospital or clinic patients without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
During enrollment, each study participant will complete a self-administered questionnaire. Information obtained from both the
cases and controls will include the following:
¿ Standard demographic data (e.g., name, mailing address, date of birth, race/ethnicity, marital status, educational attainment, occupation, family income, name of hospital/clinic of enrollment)
¿ Personal characteristics (e.g., menopausal status, smoking status, alcohol consumption, medical/surgical history, hours per day in the sun, sexual history)
¿ Disease/medication history (e.g., previously diagnosed with scleroderma, systemic lupus erythematosus (SLE), Sjogren¿s syndrome, multiple sclerosis, dermatomyositis/polymyositis, brain cancer, cervical/vulvar cancer, or lymphoma, family history of those diseases, previous treatment for any type of cancer with chemotherapy, oral contraceptive use, and previous diagnosis with Epstein-Barr virus, inflammatory bowel disease, HIV/AIDS, hepatitis B, hepatitis C, Helicobacter pylori, Chlamydia, or HPV
¿ Reproductive history (i.e., number of pregnancies, ages of children, maternal age at first birth)
The medical records of each study participant will be reviewed by designated study personnel. The following information will be abstracted from the records of both the cases and controls:
¿ Use of specific prescription medications (specific list to be developed)
¿ Type, date, and results of radiology or imaging
¿ Date of last pap smear
¿ Date of any diagnoses of scleroderma, SLE, Sjogren¿s syndrome, multiple sclerosis, dermatomyositis/polymyositis, brain cancer, cervical/vulvar cancer, or lymphoma
¿ Date of breast implantation, any revisions made to the breast implant, manufacturer and type of breast implant