The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.
Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation
The health of women must comply with ECOG performance status 0-2
The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment
Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
Pregnancy or breast-feeding patients
Known intolerance to the material, mesh-implants under investigation
Metastatic breast cancer (with a life expectancy < 5 years)
Medicinal dis-regulated diabetes
AWOgyn
Lead sponsor
Esculape GmbH
Collaborator