FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Inclusion Criteria:

* Females at least 22 years of age
* Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
* Willing to provide Informed Consent
* Able to return for all required study visits
* Must read and understand English language

Exclusion Criteria:

* Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
* Has a residual gross tumor at the intended reconstruction site
* Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
* Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
* Completed chemotherapy within 3 weeks prior to surgery
* Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
* Has a Body Mass Index (BMI) \>35
* Has used nicotine products within 1 month of screening
* Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study