Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery

Inclusion Criteria:

• Women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family historyall 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 andindependently from study enrollment

• Participant is mentally able to understand the nature, aims, or possibleconsequences of the clinical investigation

• Patient information has been handed out and subject signed informed consent

• Participant has attained full age of 18 years

Exclusion Criteria:

• 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

• Inadequate bone marrow function with neutrophil granulocytes<1500 and blood plates < 100.000/µl

• Lack or withdrawn of written patients informed consent

• Lack of patient compliance regarding data collection, treatment or follow-upinvestigations in the scope of the protocol

• Participant is institutionalized by court or official order (MPDG §27)

• Participation in another surgical clinical investigation that influence the surgicaltechnique or outcome.