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| ID | Type | Description | Link |
|---|---|---|---|
| CMO-EPI-PLS-0536 | Other Identifier | AbbVie |
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Ten year safety study examining rates of rare adverse events, child bearing issues, effects of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast implants.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBIR - US National Breast Implant Registry | Other | NBIR is intended to be a surveillance tool to track patient safety and real-world outcomes associated with breast implants used for aesthetic or reconstructive purposes.. | ||
| 410 Arm | Device | Anatomically shaped silicone gel-filled breast implants. | ||
| BIFs - Breast Implant Follow-Up Study | Device | Round silicone gel-filled breast implants and saline-filled breast implants |
| Measure | Description | Time Frame |
|---|---|---|
| Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator | 10 Years | |
| Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator | 10 Years | |
| Re-operations | Rates of reoperation reported by subjects and by investigators at office visits | 10 Years |
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Inclusion Criteria:
Screening Criteria
Female
Exhibit fluency and literacy in English or Spanish
Enrollment Criteria
For retrospectively enrolled subjects into the 410 arm, in addition to the above, these criteria also apply:
Continuation Criteria (BIFS Arm Only)
Exclusion Criteria:
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Women with breast implants for augmentation, reconstruction, or revision of augmentation or reconstruction
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Plastic Surgery /ID# 240510 | El Paso | Texas | 79925-7618 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26710009 | Derived | Singh N, Picha GJ, Murphy DK. Natrelle Silicone Breast Implant Follow-Up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 50,000 Augmentation Subjects. Plast Reconstr Surg. 2016 Jan;137(1):70-81. doi: 10.1097/PRS.0000000000001851. |
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