Overview
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.
Eligibility
Inclusion Criteria:
- Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
- Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.
Exclusion Criteria:
- Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.
- Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.