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.
Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA.
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.
Single group
ARTIA Reconstructive Tissue Matrix
DeviceSurgical Implant
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
Number of participants with at least one major complication related to breast reconstruction.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment.
Occurrence of Reconstructive Failure Per Breast After Stage 1
Number of participants with an occurrence of reconstructive failure per breast.
Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2
Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.
Occurrence of Capsular Contracture per Breast
Number of participants with an occurrence of capsular contracture per breast.
