Clinical Trials

Inclusion Criteria:

• Subject is a genetic female.
• Subject is ≥ 22 years of age at the time of enrollment.
• Subject is scheduled to undergo either unilateral or bilateral mastectomy (including prophylactic) with immediate, two-stage post-mastectomy alloplastic prepectoral breast reconstruction. 
• Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form.

Exclusion Criteria

• Subject has prior history of neoadjuvant radiotherapy.
• Subject has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
• Subject has an active abscess or infection requiring antibiotics anywhere in their body within 30 days prior to informed consent.
• Subject has a Body Mass Index (BMI) < 14 or > 40.
• Subject is pregnant or is nursing; or plans to become pregnant during the course of the study.
• Subject has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis.
• Subject has known allergies to study device materials (poly [lactic acid, co-glycolic acid]), tyrosine-based polyarylate coating, rifampin and minocycline antibacterial agents), or lactide and glycolide copolymer sutures (e.g., Vicryl®).
• Subject is participating in another interventional research study that may interfere with study endpoints.
• Subject has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that, in the opinion of the Investigator, will preclude them from participation and completion of study procedures or requirements.
• Subject has a medical condition or is taking medications that would result in elevated risk (e.g., blood clotting), and/or affect the validity of the study as determined by the Investigator; or any other clinical reasons deemed by the Investigator to make the patient an unsuitable candidate for the study.
• Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/12/23. Questions regarding updates should be directed to the study team contact.