National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)
The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or
subcutaneous mastectomy with preservation of the nipple-areola-complex during primary
breast reconstruction, secondary breast reconstruction or corrective breast surgery.
Patients shall be included if they meet all of the following criteria:
Clinical Criteria (reason):
- women with indication of prophylactic operation or oncoplastic operation with support
of a mesh implant
- women with histologically confirmed breast cancer or precancerosis or genetic
pre-existing conditions with increased risk of breast cancer or with a family history
- the health of women must comply with ECOG (Eastern Cooperative Oncology Group)
performance status 0-2
Study-related inclusion criteria - Legal reasons:
- Patient is mentally able to understand the nature, aims, or possible consequences of
the clinical investigation
- Patient information has been handed out and all written consents are at hand.
- Patient is between 18 and 75 years old.
Patients must be excluded if any of the following conditions exist or cannot be excluded:
Device-related exclusion criteria (contraindications):
Pathological or physical condition precluding such as:
- Pregnancy or breast-feeding patients
- Known intolerance to the mesh-implants under investigation.
Study-related exclusion criteria - Medical reasons:
- metastatic breast cancer
- medicamentous regulated diabetes with blood sugar level >250
- inadequate bone marrow function with neutrophil granulocytes <1500 and blood plates
- patient with known contraindication to mesh-implants or plastic-reconstructive breast
Study-related exclusion criteria - Legal reasons:
- Lack of written patients informed consent.
- Lack of patient compliance regarding data collection, treatment or follow-up
investigations in the scope of the protocol.
- Patient is institutionalized by court or official order (MPG§20.3).
- Participation in another operative clinical investigation.
It is thought that the study-related exclusion criteria will not significantly influence
the sample of the population under investigation.