The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
Timeframe: Month 18
Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2
Timeframe: Up to Month 18
Number of Participants with Adverse Events (AEs)
Timeframe: Up to Approximately 36 Months