Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study

Use of a HADM and implant in post-mastectomy breast reconstruction.

This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Inclusion Criteria:

• Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
• Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
• Skin incision may be skin sparing, or nipple-areolar sparing
• Have signed written, informed consent
• Be at least 18 years of age

Exclusion Criteria:

• Patients undergoing autologous breast reconstruction
• Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
• Patients undergoing reconstruction after previously failed attempts at reconstruction
• Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
• There will be no exclusions based on race or ethnicity
• BMI > 40
• Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.