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This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NATRELLE® INSPIRA® TruForm® 1 (Smooth) | Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants |
| |
| NATRELLE® INSPIRA® TruForm® 1 (Textured) | Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 1 breast implants |
| |
| NATRELLE® INSPIRA® TruForm® 2 (Smooth) | Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 2 breast implants |
| |
| NATRELLE® INSPIRA® TruForm® 2 (Textured) | Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 2 breast implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants | Device | Surgical implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants | 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants | 4 Years | |
| Reasons For Primary Augmentation | 4 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects that have undergone a primary breast augmentation for aesthetic reasons with NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 implant.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banff Plastic Surgery | Banff | Alberta | T1L 1B7 | Canada | ||
| Macleod Trail Plastic Surgery |
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| Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants | Device | surgical implant |
|
|
| Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants | Device | surgical implant |
|
|
| Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants | Device | surgical implant |
|
|
| Time From the Date of Implant Until First Reoperation | 4 Years |
| Reasons For Reoperation Incidence | 4 Years |
| Incidences of Implant Removal With Replacement | 4 Years |
| Incidences of Implant Removal Without Replacement | 4 Years |
| Calgary |
| Alberta |
| T2H 0L8 |
| Canada |
| Jonathan Toy | Edmonton | Alberta | T5M 327 | Canada |
| Y.E.S MedSpa & Cosmetic Surgery Centre | Langley | British Columbia | V2Y 0C8 | Canada |
| Institute of Cosmetic and Laser Surgery | Oakville | Ontario | L6J 7W5 | Canada |
| Ottawa Plastic Surgery: Dr. Howard Silverman | Ottawa | Ontario | K1Z 8R9 | Canada |
| Rice Cosmetic Surgery | Toronto | Ontario | M2J 1V1 | Canada |
| Cosmedical Rejuvenation Clinic | Toronto | Ontario | M2P 2C2 | Canada |
| Yorkville Institute of Plastic Surgery | Toronto | Ontario | M5R 2J3 | Canada |
| SpaSurgica | Waterloo | Ontario | N2J 1M3 | Canada |
| Centre de Medecine et de Chirurgie Ambulatoires Isomed | Boucherville | Quebec | J4B 7M6 | Canada |
| CCPEM | Montreal | Quebec | H3G 1B9 | Canada |
| Cosmedica | Pointe-Claire | Quebec | H9R 5N3 | Canada |
| Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville | Québec | Quebec | G1V 1R4 | Canada |
| Sebastien Nguyen MD Inc. | Québec | Quebec | G1V 4M6 | Canada |
| Cosmetic Surgery Clinic | Waterloo | Quebec | N2L 3S2 | Canada |
| Sandra McGill MD Inc. | Westmount | Quebec | H3Z 1S3 | Canada |