FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction

Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique

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