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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Post-Approval Case-Control Studies(PACCS)

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Study Status Terminated
Application Number P070004 / PAS004
Date Current Protocol Accepted 03/09/2012
Study Name OSB Lead-Post-Approval Case-Control Studies(PACCS)
General Study Protocol Parameters
Study Design Case Control Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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.

Sientra¿s Silicone 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:

¿ Female

¿ 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)

Sample Size 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.
Data Collection 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

Follow-up Visits and Length of Follow-up There is no follow-up for case-control studies

OSB Lead-Post-Approval Case-Control Studies(PACCS) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
quarterly report 06/08/2012 06/08/2012 On Time
six month report 09/07/2012 09/07/2012 On Time
2nd quarterly report 12/09/2012 12/07/2012 On Time
one year report 03/09/2013 03/01/2013 On Time
15 month report 09/06/2013 06/05/2013 On Time
18 month report 09/07/2013 09/06/2013 On Time
two year report 03/09/2014 02/25/2014 On Time
three year report 03/09/2015 03/12/2015 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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