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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P070004 / PAS003 |
| Date Original Protocol Accepted |
03/09/2012
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| Date Current Protocol Accepted |
05/26/2023
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| Study Name |
US Post-Approval Study (US-PAS)
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| Device Name |
SIENTRA SILICONE GEL BREAST IMPLANTS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The US-PAS is a 10-year post-approval cohort study to examine local complications and common diseases recommended by FDA for inclusion in the PAS. Common diseases were defined as conditions with incidence rates greater than 10/100,000. For evaluation of common diseases; reproductive outcomes, and suicide/attempted suicide, external comparisons will be made between the breast implant group and population-based disease rates derived from reliable data sources, from disease rate estimates available from other registries or epidemiologic studies, or from preoperative data. Internal comparisons will be made to baseline observations for quality of life endpoints. For the analysis of rheumatologic and neurologic signs and symptoms, the internal comparison group will be participants undergoing other aesthetic surgery.
The study will enroll women who receive Sientra Silicone Gel Breast Implants for augmentation, revision augmentation, reconstruction, and revision reconstruction (these patients are referred to as “Gel participants”) in the naturally occurring proportions of these procedures at participating study sites. Participants will be followed over a 10-year period following breast implant surgery for common outcomes and all local complications. Gel participants will be evaluated by the Investigator at baseline and years 1, 5, and 9 and will complete questionnaires at baseline and years 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10. A concurrent control group of women undergoing other aesthetic surgery (these patients are referred to as Control participants) will also be enrolled and will complete questionnaires at baseline and years 2, 4, 6, and 8.
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| Study Population |
The device group will be women who received Sientras silicone breast implants as indicated for primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction of the female breast. The control group will be women undergoing other aesthetic surgery.
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| Sample Size |
The study will enroll 4,782 women receiving Sientras silicone breast implants and 300 women undergoing other aesthetic surgery as the comparison group.
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| Key Study Endpoints |
The following safety outcomes will be evaluated: connective tissue diseases (CTDs), rheumatologic and neurologic signs and symptoms, cancer (lung and breast, including the potential of breast implant interference with mammography and delay of breast cancer detection), suicide/attempted suicide, local complications, reoperation and implant removal, reproductive and lactation complications. Effectiveness will be assessed based on quality of life (QOL) assessments and subject satisfaction.
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| Follow-up Visits and Length of Follow-up |
10 years
Investigator evaluations of breast implant participants will occur at baseline and years 1, 5, and 9. Additional study data will be obtained via questionnaires completed by the breast implant and Control participants. Breast implant participants will complete a baseline questionnaire, a condensed follow-up questionnaire at years 1, 5, and 9, and a standard follow-up questionnaire at years 3, 7 and 10. At years 2, 4, 6, and 8 they will complete a QOL and Signs/Symptoms questionnaire regarding QOL, suicide/attempted suicide, participant satisfaction, rheumatologic and neurologic signs and symptoms.
Control participants will complete a baseline questionnaire. At years 2, 4, 6, and 8 they will complete a Signs/Symptoms questionnaire that will collect information on rheumatologic and neurologic signs and symptoms. The subgroup of 1,000 breast implant participants will receive additional reproductive outcome questions at years 1, 3, 5, 7, 9 and 10.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
5,498 total subjects
5,197 Sientra OPUS® Silicone Gel Breast Implant subjects
301 Control subjects
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| Actual Number of Sites Enrolled |
131
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| Patient Follow-up Rate |
The 3 year follow-up rates are:
61% - Sientra OPUS Silicone Gel Breast Implant cohort
The Control population did not have a visit at the 3 year timepoint
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