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 immediateimplant-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 ofstudy procedure

• Has a residual gross tumor at the intended reconstruction site

• Has undergone previous breast surgery, such as lumpectomy or breast augmentation, atthe 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 reconstructionsite

• Completed chemotherapy within 3 weeks prior to surgery

• Has been diagnosed with a comorbid condition determined by the investigator to placethe 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 theprocedure or have a history of long-term use of systemic oral corticosteroids oranticipate the use during course of the study