Overview
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.
Description
This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.
Eligibility
Inclusion Criteria:
- Women with histologically confirmed breast cancer or precancerosis or genetic preexisting 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
- 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- Lack or withdrawn of written patients informed consent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-up investigations 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 surgical technique or outcome.