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The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast enhancement |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI | 4 years | |
| Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography. | 4 years | |
| Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects treated in study 31GB0607
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| Name | Affiliation | Role |
|---|---|---|
| Per Hedén, M.D. | Akademikliniken, Stockholm, Sweden | Principal Investigator |
| Michael Olenius, M.D. | Proforma Clinic AB, Stockholm, Sweden | Principal Investigator |
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| 4 years |
| Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s) | 4 years |
| Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography. | 6 years |
| Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos | 6 years |
| Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s) | 6 years |