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
Women who will undergo breast prepectoral implant-based breast reconstructive surgery
Cohort
Prospective
TIGR® Matrix
Devicebioresorbable, synthetic, surgical mesh
Quality of Life 12 months after surgery (BREAST-Q)
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
Quality of Life 6, 24, 36 months after surgery (BREAST-Q)
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
Complication rate
The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs)
Complication rate of specific complications
Complication rate of: * Seroma-Volume (Sum of fluid-volume during the drainage-time) * Need for aspiration in symptomatic patients, number of aspirations in postoperative follow up * Reconstructive failure (defined as unplanned implant loss)
Days with drain(s)
The number of days between placement of drain system and removal of the drain
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AWOgyn
Lead sponsor
Esculape GmbH
Collaborator
