Trial Information
Inclusion Criteria:
1. Females previously treated with Macrolane VRF in the breasts
2. Females continuously being treated with Macrolane VRF in the breasts, initial
treatment or re-treatment.
Exclusion Criteria:
No exclusion criteria
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
To document the incidence of breast cancer in female subjects after treatment with Macrolane VRFs in the breasts when the product is used in clinical practice.
Outcome Time Frame:
2010-2015
Safety Issue:
Yes
Authority:
Sweden: Regional Ethical Review Board
Study ID:
31GB0905
NCT ID:
NCT01145235
Start Date:
April 2010
Completion Date:
Related Keywords:
- Breast Augmentation
- Breast augmentation with Macrolane